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A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema (RHINE)

Primary Purpose

Diabetic Macular Edema

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Aflibercept

Faricimab

Sham Procedure

About this trial

This is an interventional treatment trial for Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Documented diagnosis of diabetes mellitus (Type 1 or Type 2)
Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1
Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea
Decreased visual acuity attributable primarily to DME
Ability and willingness to undertake all scheduled visits and assessments
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment

Exclusion Criteria:

Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1
Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest
Currently pregnant or breastfeeding, or intend to become pregnant during the study
Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye
Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye
Prior administration of IVT faricimab in either eye
Active intraocular or periocular infection or active intraocular inflammation in the study eye
Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye
Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye
Other protocol-specified inclusion/exclusion criteria may apply

Sites / Locations

Retinal Research Institute, LLC
Associated Retina Consultants
Northwest Arkansas Retina Associates
California Retina Consultants
Retina-Vitreous Associates Medical Group
The Retina Partners
Retina Consultants of Orange County
Northern California Retina Vitreous Associates
Retinal Consultants Med Group
California Retina Consultants
Bay Area Retina Associates
University of Colorado; dept of ophthalmology
Retina Consultants of Southern
Retina Group of New England
Retina Group of Florida
National Ophthalmic Research Institute
Florida Eye Associates
Bascom Palmer Eye Institute
Fort Lauderdale Eye Institute
Retina Vitreous Assoc of FL
Southeast Retina Center
University Retina and Macula Associates, PC
Prairie Retina Center
Retina Specialists
Tufts Medical Center; Ophthalmology
Associated Retinal Consultants
Vitreo-Retinal Associates
Retina Consultants of Nevada
Envision Ocular, LLC
Long Is. Vitreoretinal Consult
New York University
Ophthalmic Cons of Long Island
Retina Assoc of Western NY
University of Rochester Flaum Eye Institute
The Retina Consultants
Cleveland Clinic Foundation; Cole Eye Institute
Mid Atlantic Retina - Wills Eye Hospital
Retina Consultants Of Carolina
Charleston Neuroscience Inst
Palmetto Retina Center
Southeastern Retina Associates Chattanooga
Southeastern Retina Associates
Tennessee Retina PC
Austin Retina Associates
Retina Center of Texas
Retina Consultants of Texas
Univ of Virginia Ophthalmology
Retina Institute of Virginia
Retina Center Northwest
Fundacion Zambrano
Oftalmos
Oftar
Centro Oftalmólogos Especialistas
Grupo Laser Vision
Organizacion Medica de Investigacion
Strathfield Retina Clinic
Sydney Eye Hospital
Sydney Retina Clinic and Day Surgery
Sydney West Retina
Centre For Eye Research Australia
Retina Specialists Victoria
The Lions Eye Institute
Hospital de Olhos de Aparecida - HOA
Centro Brasileiro de Cirurgia
Hospital das Clinicas - UFRGS
Botelho Hospital da Visao
Faculdade de Medicina do ABC - FMABC
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
CEMAPE - Centro Médico
Hospital das Clinicas - FMUSP
Hosp de Olhos de Sorocaba
Calgary Retina Consultants
University of British Columbia - Vancouver Coastal Health Authority
QEII - HSC Department of Ophthalmology
Vitreous Retina Macula Specialists of Toronto
Ivey Eye Institute
University of Ottawa Eye Institute
Toronto Retina Institute
Unity Health Toronto
University Health Network Toronto Western Hospital
Institut De L'Oeil Des Laurentides
Hôpital Maisonneuve - Rosemont
Peking Union Medical College Hospital
Beijing Friendship Hospital
Beijing Tongren Hospital
The Second Hospital of Jilin University
West China Hospital, Sichuan University
Southwest Hospital , Third Military Medical University; Ophthalmology
Army Medical Center of PLA(Daping Hospital)
Zhongshan Ophthalmic Center, Sun Yat-sen University
The Affiliated Eye Hospital of Nanjing Medical University
Shanghai Tenth People's Hospital
Shanghai First People's Hospital
Tianjin Eye Hospital
Tianjin Medical University Eye Hospital
Eye Hospital, Wenzhou Medical University
Wuxi No.2 People's Hospital
FN Hradec Králové, O?ní klinika; Ophthalmology clinic
Faculty Hospital Ostrava; Ophthalmology clinic
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
AXON Clinical
Nemocnice Sokolov
Aalborg Universitetshospital; Øjenafdelingen
Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Chi De Creteil; Ophtalmologie
CHU Bocage; Ophtalmologie
Hopital de la croix rousse; Ophtalmologie
CHNO des Quinze Vingts; Ophtalmologie
Centre Ophtalmologique; Imagerie et laser
Centres Ophtalmologique St Exupéry; Ophtalmologie
Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie
Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde
Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik
LMU Klinikum der Universität, Augenklinik
Klinikum rechts der Isar der TU München; Augenklinik
Universitätsklinikum Würzburg, Augenklinik und Poliklinik
Queen Mary Hospital; Department of Ophthalmology
Hong Kong Eye Hospital; CUHK Eye Centre
Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály
Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR
Semmelweis Egyetem Szemészeti Vizsgálóhely
Bajcsy-Zsilinszky Hospital
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria
Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Seoul National University Bundang Hospital
Kyung Hee University Hospital
Seoul National University Hospital
Samsung Medical Center
Asan Medical Center.
OFTALMIKA Sp. z o.o
Specjalistyczny O?rodek Okulistyczny Oculomedica
Optimum Profesorskie Centrum Okulistyki
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej
Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow
Caminomed
Centrum Zdrowia MDM
Hospital de Braga; Servico de Oftalmologia
AIBILI - Association for Innovation and Biomedical Research on Light
Espaco Medico Coimbra
Hospital de Santa Maria; Servico de Oftalmologia
Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch
Clinics of Eye Diseases, LLC
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
National University Hospital; Ophthalmology Department
Singapore Eye Research Institute
Tan Tock Seng Hospital; Ophthalmology Department
Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
Hospital Universitario de Bellvitge
Hospital General de Catalunya
Complejo Hospitalario de Navarra; Servicio de oftalmologia
Oftalvist Valencia
Institut de la Macula i la retina
Hospital dos de maig; Pharmacy Service
Hospital Clinico San Carlos; Servicio de oftalmologia
Clinica Baviera; Servicio Oftalmologia
Fisabio-Ofalmologia Medica; Servicio de Oftalmología
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Vista Klinik Ophthalmologische Klinik
Taipei Veterans General Hospital; Ophthalmology
Chang Gung Medical Foundation - Linkou; Ophthalmology
National Taiwan University Hospital; Ophthalmology
King Chulalongkorn Memorial Hospital; Ophthalmology Department
Rajavithi Hospital; Ophthalmology Department
Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department
Ankara University Medical Faculty; Department of Ophthalmology
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology
Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology
Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Bradford Royal Infirmary
University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital
East Kent Hospitals University NHS Foundation Trust
Frimley Park Hospital
Gloucestershire Hospitals NHS Foundation Trust
St James University Hospital
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Moorfields Eye Hospital NHS Foundation Trust
Royal Free Hospital
Kings College Hospital
Manchester Royal Eye Hospital
Hillingdon Hospital
Royal Victoria Infirmary
James Paget University Hospitals NHS Foundation Trust
University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit
Sunderland Eye Infirmary

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

A: Faricimab 6 mg Q8W

B: Faricimab 6 mg PTI

C: Aflibercept 2 mg Q8W

Arm Description

Participants randomized to Arm A received 6 milligrams (mg) faricimab intravitreal (IVT) injections once every 4 weeks (Q4W) to Week 20, followed by 6 mg faricimab IVT injections once every 8 weeks (Q8W) to Week 96, followed by the final study visit at Week 100.

Participants randomized to Arm B received 6 milligrams (mg) faricimab intravitreal (IVT) injections Q4W to at least Week 12, followed by a personalized treatment interval (PTI) dosing of 6 mg faricimab IVT injections up to once every 16 weeks (Q16W) through Week 96, followed by the final study visit at Week 100.

Participants randomized to Arm C received 2 milligrams (mg) aflibercept intravitreal (IVT) injections Q4W to Week 16, followed by 2 mg aflibercept IVT injections Q8W to Week 96, followed by the final study visit at Week 100.

Outcomes

Primary Outcome Measures

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded. 97.5% CI is a rounding of 97.52% CI.

Secondary Outcome Measures

Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity (DRS) Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale (DRSS) at Week 52, ITT and Treatment-Naive Populations

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 97.5% confidence interval (CI) is a rounding of 97.52% CI.

Change From Baseline in BCVA in the Study Eye Over Time, ITT Population

Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population

Best-Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline BCVA (continuous), baseline BCVA (<64 vs. ≥64 letters), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, Treatment-Naive Population

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.

Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR. High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population

Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 52 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations

Percentage of Participants in the Faricimab 6 mg PTI Arm at Week 96 Who Achieved a Once Every 12-Weeks or 16-Weeks Treatment Interval Without an Interval Decrease Below Once Every 12 Weeks, ITT and Treatment-Naive Populations

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.

Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population

Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Absence of diabetic macular edema was defined as achieving a central subfield thickness (CST) of <325 microns in the study eye. CST was defined as the distance between the internal limiting membrane and Bruch's membrane. For each participant, an average CST value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population

Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population

Retinal dryness was defined as achieving a central subfield thickness (ILM-BM) of <280 microns. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted estimates of the percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population

Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population

Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population

Intraretinal fluid and subretinal fluid were measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world); Asia and rest of the world regions were combined due to a small number of enrolled participants. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population

The NEI VFQ-25 captures a patient's perception of vision-related functioning and quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and one item on general health. The composite score ranges from 0 to 100, with higher scores, or a positive change from baseline, indicating better vision-related functioning. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA (<64 vs. ≥64 letters), prior intravitreal anti-VEGF therapy (yes vs. no), and region of enrollment. An unstructured covariance structure was used. Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% CI is a rounding of 95.04% CI.

Percentage of Participants With at Least One Adverse Event

This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. AEs of special interest included the following: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law; Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation.

Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye

This analysis of adverse events (AEs) only includes ocular AEs, which are categorized as having occurred either in the study eye or the fellow eye. Investigators sought information on AEs at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. Ocular AEs of special interest included the following: Suspected transmission of an infectious agent by the study drug; Sight-threatening AEs that cause a drop in visual acuity (VA) score ≥30 letters lasting more than 1 hour, require surgical or medical intervention to prevent permanent loss of sight, or are associated with severe intraocular inflammation (IOI).

Percentage of Participants With at Least One Non-Ocular Adverse Event

This analysis of adverse events (AEs) only includes non-ocular (systemic) AEs. Investigators sought information on adverse events (AEs) at each contact with the participants. All AEs were recorded and the investigator made an assessment of seriousness, severity, and causality of each AE. The non-ocular AE of special interest was: Cases of potential drug-induced liver injury that include an elevated ALT or AST in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's Law.

Plasma Concentration of Faricimab Over Time

Faricimab concentration in plasma was determined using a validated immunoassay method.

Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study

Anti-drug antibodies (ADAs) against fariciamb were detected in plasma using a validated bridging enzyme-linked immunosorbent assay (ELISA). The percentage of participants with treatment-emergent ADA-positive samples includes post-baseline evaluable participants with at least one treatment-induced (defined as having an ADA-negative sample or missing sample at baseline and any positive post-baseline sample) or treatment-boosted (defined as having an ADA-positive sample at baseline and any positive post-baseline sample with a titer that is equal to or greater than 4-fold baseline titer) ADA-positive sample during the study treatment period.

Full Information

NCT ID

NCT03622593

First Posted

August 1, 2018

Last Updated

June 20, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03622593

Brief Title

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

Acronym

RHINE

Official Title

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

October 9, 2018 (Actual)

Primary Completion Date

October 19, 2020 (Actual)

Study Completion Date

August 27, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

This study will evaluate the efficacy, safety, and pharmacokinetics of faricimab administered at 8-week intervals or as specified in the protocol following treatment initiation, compared with aflibercept once every 8 weeks (Q8W), in participants with diabetic macular edema (DME).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Diabetic Macular Edema

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

951 (Actual)

8. Arms, Groups, and Interventions

Arm Title

A: Faricimab 6 mg Q8W

Arm Type

Experimental

Arm Description

Arm Title

B: Faricimab 6 mg PTI

Arm Type

Experimental

Arm Description

Arm Title

C: Aflibercept 2 mg Q8W

Arm Type

Active Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea

Intervention Description

Aflibercept 2 mg was administered by intravitreal (IVT) injection into the study eye once every 8 weeks (Q8W).

Intervention Type

Drug

Intervention Name(s)

Faricimab

Other Intervention Name(s)

VABYSMO™, RO6867461, RG7716

Intervention Description

Faricimab 6 mg was administered by IVT injection into the study eye either once every 8 weeks (Q8W) in arm A or according to a personalized treatment interval (PTI) in arm B.

Intervention Type

Procedure

Intervention Name(s)

Sham Procedure

Intervention Description

The sham is a procedure that mimics an IVT injection and involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It was administered to participants in all three treatments arms at applicable visits to maintain masking among treatment arms.

Primary Outcome Measure Information:

Title

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Description

Time Frame

From Baseline through Week 56

Secondary Outcome Measure Information:

Title

Description

Time Frame

Baseline and Week 52

Title

Change From Baseline in BCVA in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Change From Baseline in BCVA in the Study Eye Over Time, Treatment-Naive Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population

Description

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥15, ≥10, ≥5, or ≥0 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population

Description

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Gaining ≥0 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT Population

Description

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters in BCVA From Baseline in the Study Eye Averaged Over Weeks 48, 52, and 56, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The weighted estimates of the percentage of participants avoiding a loss of letters in BCVA from baseline were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Description

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Description

BCVA was measured on the ETDRS chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA from baseline indicates an improvement in visual acuity. For each participant, an average BCVA value was calculated across the three visits, and this averaged value was then used to determine if the endpoint was met. The results were summarized as the percentage of participants per treatment arm who met the endpoint. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world). Treatment policy strategy and hypothetical strategy were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥69 vs. <69 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Description

Time Frame

Baseline, average of Weeks 48, 52, and 56

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, ITT Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement invisual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Over Time, Treatment-Naive Population

Description

Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score attainable), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. Invalid BCVA values were excluded from analysis. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With a ≥2-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Percentage of Participants With a ≥3-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Percentage of Participants With a ≥4-Step Diabetic Retinopathy Severity Improvement From Baseline on the ETDRS Diabetic Retinopathy Severity Scale in the Study Eye Over Time, ITT Population

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy. Ocular imaging assessments were made independently by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters) and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 16, 52, and 96

Title

Percentage of Participants Without Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed New PDR at Week 52, ITT and Treatment-Naive Populations

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced proliferative diabetic retinopathy (PDR). PDR was defined as an ETDRS DRSS score of ≥61 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted percentages of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.

Time Frame

Baseline and Week 52

Title

Percentage of Participants Without High-Risk Proliferative Diabetic Retinopathy (PDR) at Baseline Who Developed High-Risk PDR at Week 52, ITT and Treatment-Naive Populations

Description

The Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) classifies diabetic retinopathy into 12 severity steps ranging from absence of retinopathy to advanced PDR. High-risk PDR was defined as an ETDRS DRSS score of ≥71 on the 7-field/4-wide field color fundus photographs assessment by a central reading center. The weighted estimates of the percentage of participants were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥64 vs. <64 letters), prior IVT anti-VEGF therapy (yes vs. no), and region (U.S. and Canada vs. rest of the world; Asia and rest of the world regions were combined). Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were not imputed. 95% CI is a rounding of 95.04% CI.

Time Frame

Baseline and Week 52

Title

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, ITT Population

Time Frame

Week 52

Title

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 52, Treatment-Naive Population

Time Frame

Week 52

Title

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, ITT Population

Time Frame

Week 96

Title

Percentage of Participants in the Faricimab 6 mg PTI Arm on a Once Every 4-Weeks, 8-Weeks, 12-Weeks, or 16-Weeks Treatment Interval at Week 96, Treatment-Naive Population

Time Frame

Week 96

Title

Time Frame

From start of PTI (Week 12 or later) until Week 52

Title

Time Frame

From start of PTI (Week 12 or later) until Week 96

Title

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Description

Time Frame

From Baseline through Week 56

Title

Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Change From Baseline in Central Subfield Thickness in the Study Eye Over Time, Treatment-Naive Population

Description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. For the Mixed Model for Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (<64 vs. ≥64 letters), and region of enrollment (U.S. and Canada vs. the rest of the world; Asia and rest of the world regions were combined). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after the occurrence of the intercurrent event) were applied to non-COVID-19 related and COVID-19 related intercurrent events, respectively. Missing data were implicitly imputed by MMRM. 95% confidence interval (CI) is a rounding of 95.04% CI.

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Averaged Over Weeks 48, 52, and 56, ITT and Treatment-Naive Populations

Description

Time Frame

Average of Weeks 48, 52, and 56

Title

Percentage of Participants With Absence of Diabetic Macular Edema in the Study Eye Over Time, ITT Population

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With Retinal Dryness in the Study Eye Over Time, ITT Population

Description

Time Frame

Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, 72, 76, 80, 84, 88, 92, 96, and 100

Title

Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100

Title

Percentage of Participants With Absence of Subretinal Fluid in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100

Title

Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 16, 48, 52, 56, 92, 96, and 100

Title

Change From Baseline in the National Eye Institute Visual Functioning Questionnaire-25 (NEI VFQ-25) Composite Score Over Time, ITT Population

Description

Time Frame

Baseline, Weeks 24, 52, and 100

Title

Percentage of Participants With at Least One Adverse Event

Description

Time Frame

From first dose of study drug through end of study (up to 2 years)

Title

Percentage of Participants With at Least One Ocular Adverse Event in the Study Eye or the Fellow Eye

Description

Time Frame

From first dose of study drug through end of study (up to 2 years)

Title

Percentage of Participants With at Least One Non-Ocular Adverse Event

Description

Time Frame

From first dose of study drug through end of study (up to 2 years)

Title

Plasma Concentration of Faricimab Over Time

Description

Faricimab concentration in plasma was determined using a validated immunoassay method.

Time Frame

Pre-dose on Day 1 (Baseline); Weeks 4, 28, 52, 76, and 100

Title

Percentage of Participants Who Test Positive for Treatment-Emergent Anti-Drug Antibodies Against Faricimab During the Study

Description

Time Frame

Baseline, Weeks 4, 28, 52, 76, and 100

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Documented diagnosis of diabetes mellitus (Type 1 or Type 2) Hemoglobin A1c (HbA1c) of less than or equal to (≤)10% within 2 months prior to Day 1 Macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea Decreased visual acuity attributable primarily to DME Ability and willingness to undertake all scheduled visits and assessments For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods that result in a failure rate of <1% per year during the treatment period and for at least 3 months after the final dose of study treatment Exclusion Criteria: Currently untreated diabetes mellitus or previously untreated patients who initiated oral or injectable anti-diabetic medication within 3 months prior to Day 1 Uncontrolled blood pressure, defined as a systolic value greater than (>)180 millimeters of mercury (mmHg) and/or a diastolic value >100 mmHg while a patient is at rest Currently pregnant or breastfeeding, or intend to become pregnant during the study Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye Any intraocular or periocular corticosteroid treatment within 6 months prior to Day 1 to the study eye Prior administration of IVT faricimab in either eye Active intraocular or periocular infection or active intraocular inflammation in the study eye Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye Other protocol-specified inclusion/exclusion criteria may apply

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Clinical Trials

Organizational Affiliation

Hoffmann-La Roche

Official's Role

Study Director

Facility Information:

Facility Name

Retinal Research Institute, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Associated Retina Consultants

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Northwest Arkansas Retina Associates

City

Springdale

State/Province

Arkansas

ZIP/Postal Code

72762

Country

United States

Facility Name

California Retina Consultants

City

Bakersfield

State/Province

California

ZIP/Postal Code

93309

Country

United States

Facility Name

Retina-Vitreous Associates Medical Group

City

Beverly Hills

State/Province

California

ZIP/Postal Code

90211

Country

United States

Facility Name

The Retina Partners

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Retina Consultants of Orange County

City

Fullerton

State/Province

California

ZIP/Postal Code

92835-3424

Country

United States

Facility Name

Northern California Retina Vitreous Associates

City

Mountain View

State/Province

California

ZIP/Postal Code

94040

Country

United States

Facility Name

Retinal Consultants Med Group

City

Sacramento

State/Province

California

ZIP/Postal Code

95825

Country

United States

Facility Name

California Retina Consultants

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93103

Country

United States

Facility Name

Bay Area Retina Associates

City

Walnut Creek

State/Province

California

ZIP/Postal Code

94598

Country

United States

Facility Name

University of Colorado; dept of ophthalmology

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

Facility Name

Retina Consultants of Southern

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80909

Country

United States

Facility Name

Retina Group of New England

City

Waterford

State/Province

Connecticut

ZIP/Postal Code

06385

Country

United States

Facility Name

Retina Group of Florida

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

National Ophthalmic Research Institute

City

Fort Myers

State/Province

Florida

ZIP/Postal Code

33912

Country

United States

Facility Name

Florida Eye Associates

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Bascom Palmer Eye Institute

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33418

Country

United States

Facility Name

Fort Lauderdale Eye Institute

City

Plantation

State/Province

Florida

ZIP/Postal Code

33324

Country

United States

Facility Name

Retina Vitreous Assoc of FL

City

Saint Petersburg

State/Province

Florida

ZIP/Postal Code

33711

Country

United States

Facility Name

Southeast Retina Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

University Retina and Macula Associates, PC

City

Oak Forest

State/Province

Illinois

ZIP/Postal Code

60452

Country

United States

Facility Name

Prairie Retina Center

City

Springfield

State/Province

Illinois

ZIP/Postal Code

62704

Country

United States

Facility Name

Retina Specialists

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Tufts Medical Center; Ophthalmology

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02111

Country

United States

Facility Name

Associated Retinal Consultants

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Vitreo-Retinal Associates

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49546

Country

United States

Facility Name

Retina Consultants of Nevada

City

Las Vegas

State/Province

Nevada

ZIP/Postal Code

89144

Country

United States

Facility Name

Envision Ocular, LLC

City

Bloomfield

State/Province

New Jersey

ZIP/Postal Code

07003

Country

United States

Facility Name

Long Is. Vitreoretinal Consult

City

Hauppauge

State/Province

New York

ZIP/Postal Code

11788

Country

United States

Facility Name

New York University

City

New York

State/Province

New York

ZIP/Postal Code

10017

Country

United States

Facility Name

Ophthalmic Cons of Long Island

City

Oceanside

State/Province

New York

ZIP/Postal Code

11572

Country

United States

Facility Name

Retina Assoc of Western NY

City

Rochester

State/Province

New York

ZIP/Postal Code

14620

Country

United States

Facility Name

University of Rochester Flaum Eye Institute

City

Rochester

State/Province

New York

ZIP/Postal Code

14642

Country

United States

Facility Name

The Retina Consultants

City

Slingerlands

State/Province

New York

ZIP/Postal Code

12159

Country

United States

Facility Name

Cleveland Clinic Foundation; Cole Eye Institute

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44195-0001

Country

United States

Facility Name

Mid Atlantic Retina - Wills Eye Hospital

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19107

Country

United States

Facility Name

Retina Consultants Of Carolina

City

Greenville

State/Province

South Carolina

ZIP/Postal Code

29605

Country

United States

Facility Name

Charleston Neuroscience Inst

City

Ladson

State/Province

South Carolina

ZIP/Postal Code

29456

Country

United States

Facility Name

Palmetto Retina Center

City

West Columbia

State/Province

South Carolina

ZIP/Postal Code

29169

Country

United States

Facility Name

Southeastern Retina Associates Chattanooga

City

Chattanooga

State/Province

Tennessee

ZIP/Postal Code

37421

Country

United States

Facility Name

Southeastern Retina Associates

City

Knoxville

State/Province

Tennessee

ZIP/Postal Code

37923

Country

United States

Facility Name

Tennessee Retina PC

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Austin Retina Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705-1169

Country

United States

Facility Name

Retina Center of Texas

City

Southlake

State/Province

Texas

ZIP/Postal Code

76092

Country

United States

Facility Name

Retina Consultants of Texas

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77384-4167

Country

United States

Facility Name

Univ of Virginia Ophthalmology

City

Charlottesville

State/Province

Virginia

ZIP/Postal Code

22903

Country

United States

Facility Name

Retina Institute of Virginia

City

Richmond

State/Province

Virginia

ZIP/Postal Code

23235

Country

United States

Facility Name

Retina Center Northwest

City

Silverdale

State/Province

Washington

ZIP/Postal Code

98383

Country

United States

Facility Name

Fundacion Zambrano

City

Caba

ZIP/Postal Code

C1017AAO

Country

Argentina

Facility Name

Oftalmos

City

Capital Federal

ZIP/Postal Code

C1120AAN

Country

Argentina

Facility Name

Oftar

City

Mendoza

ZIP/Postal Code

M5500GGK

Country

Argentina

Facility Name

Centro Oftalmólogos Especialistas

City

Rosario

ZIP/Postal Code

S2000ANJ

Country

Argentina

Facility Name

Grupo Laser Vision

City

Rosario

ZIP/Postal Code

S2000DLA

Country

Argentina

Facility Name

Organizacion Medica de Investigacion

City

San Nicolás

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Strathfield Retina Clinic

City

Strathfield

State/Province

New South Wales

ZIP/Postal Code

2135

Country

Australia

Facility Name

Sydney Eye Hospital

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

Facility Name

Sydney Retina Clinic and Day Surgery

City

Sydney

State/Province

New South Wales

ZIP/Postal Code

2000

Country

Australia

Facility Name

Sydney West Retina

City

Westmead

State/Province

New South Wales

ZIP/Postal Code

2145

Country

Australia

Facility Name

Centre For Eye Research Australia

City

East Melbourne

State/Province

Victoria

ZIP/Postal Code

3002

Country

Australia

Facility Name

Retina Specialists Victoria

City

Rowville

State/Province

Victoria

ZIP/Postal Code

3178

Country

Australia

Facility Name

The Lions Eye Institute

City

Nedlands

State/Province

Western Australia

ZIP/Postal Code

6009

Country

Australia

Facility Name

Hospital de Olhos de Aparecida - HOA

City

Aparecida de Goiania

State/Province

ZIP/Postal Code

74980-010

Country

Brazil

Facility Name

Centro Brasileiro de Cirurgia

City

Goiania

State/Province

ZIP/Postal Code

74210-010

Country

Brazil

Facility Name

Hospital das Clinicas - UFRGS

City

Porto Alegre

State/Province

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Botelho Hospital da Visao

City

Blumenau

State/Province

ZIP/Postal Code

89052-504

Country

Brazil

Facility Name

Faculdade de Medicina do ABC - FMABC

City

Santo Andre

State/Province

ZIP/Postal Code

09060-650

Country

Brazil

Facility Name

Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia

City

Sao Paulo

State/Province

ZIP/Postal Code

04023-062

Country

Brazil

Facility Name

CEMAPE - Centro Médico

City

Sao Paulo

State/Province

ZIP/Postal Code

04084-002

Country

Brazil

Facility Name

Hospital das Clinicas - FMUSP

City

Sao Paulo

State/Province

ZIP/Postal Code

05403-900

Country

Brazil

Facility Name

Hosp de Olhos de Sorocaba

City

Sorocaba

State/Province

ZIP/Postal Code

18031-060

Country

Brazil

Facility Name

Calgary Retina Consultants

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2J 0C8

Country

Canada

Facility Name

University of British Columbia - Vancouver Coastal Health Authority

City

Vancouver

State/Province

British Columbia

ZIP/Postal Code

V5Z 1M9

Country

Canada

Facility Name

QEII - HSC Department of Ophthalmology

City

Halifax

State/Province

Nova Scotia

ZIP/Postal Code

B3H 2Y9

Country

Canada

Facility Name

Vitreous Retina Macula Specialists of Toronto

City

Etobicoke

State/Province

Ontario

ZIP/Postal Code

M8X 2X3

Country

Canada

Facility Name

Ivey Eye Institute

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 4V2

Country

Canada

Facility Name

University of Ottawa Eye Institute

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K1H 8L6

Country

Canada

Facility Name

Toronto Retina Institute

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M3C 0G9

Country

Canada

Facility Name

Unity Health Toronto

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B IW8

Country

Canada

Facility Name

University Health Network Toronto Western Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5T 2S9

Country

Canada

Facility Name

Institut De L'Oeil Des Laurentides

City

Boisbriand

State/Province

Quebec

ZIP/Postal Code

J7H 0E8

Country

Canada

Facility Name

Hôpital Maisonneuve - Rosemont

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T 2M4

Country

Canada

Facility Name

Peking Union Medical College Hospital

City

Beijing City

ZIP/Postal Code

100032

Country

China

Facility Name

Beijing Friendship Hospital

City

Beijing

ZIP/Postal Code

100050

Country

China

Facility Name

Beijing Tongren Hospital

City

Beijing

ZIP/Postal Code

100730

Country

China

Facility Name

The Second Hospital of Jilin University

City

Changchun

ZIP/Postal Code

130041

Country

China

Facility Name

West China Hospital, Sichuan University

City

Chengdu

ZIP/Postal Code

610041

Country

China

Facility Name

Southwest Hospital , Third Military Medical University; Ophthalmology

City

Chongqing City

ZIP/Postal Code

400014

Country

China

Facility Name

Army Medical Center of PLA(Daping Hospital)

City

Chongqing City

ZIP/Postal Code

400042

Country

China

Facility Name

Zhongshan Ophthalmic Center, Sun Yat-sen University

City

Guangzhou City

ZIP/Postal Code

510060

Country

China

Facility Name

The Affiliated Eye Hospital of Nanjing Medical University

City

Nanjing City

ZIP/Postal Code

210029

Country

China

Facility Name

Shanghai Tenth People's Hospital

City

Shanghai

ZIP/Postal Code

200072

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

Tianjin Eye Hospital

City

Tianjin City

ZIP/Postal Code

300050

Country

China

Facility Name

Tianjin Medical University Eye Hospital

City

Tianjin City

ZIP/Postal Code

300070

Country

China

Facility Name

Eye Hospital, Wenzhou Medical University

City

Wenzhou City

ZIP/Postal Code

325027

Country

China

Facility Name

Wuxi No.2 People's Hospital

City

Wuxi

ZIP/Postal Code

214000

Country

China

Facility Name

FN Hradec Králové, O?ní klinika; Ophthalmology clinic

City

Hradec Králové

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Faculty Hospital Ostrava; Ophthalmology clinic

City

Ostrava

ZIP/Postal Code

708 52

Country

Czechia

Facility Name

Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic

City

Prague

ZIP/Postal Code

100 34

Country

Czechia

Facility Name

AXON Clinical

City

Prague

Country

Czechia

Facility Name

Nemocnice Sokolov

City

Sokolov

ZIP/Postal Code

356 01

Country

Czechia

Facility Name

Aalborg Universitetshospital; Øjenafdelingen

City

Aalborg

ZIP/Postal Code

9000

Country

Denmark

Facility Name

Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning

City

Glostrup

ZIP/Postal Code

2600

Country

Denmark

Facility Name

Sjællands Universitetshospital, Roskilde; Øjenafdelingen

City

Roskilde

ZIP/Postal Code

4000

Country

Denmark

Facility Name

Chi De Creteil; Ophtalmologie

City

Creteil

ZIP/Postal Code

94010

Country

France

Facility Name

CHU Bocage; Ophtalmologie

City

Dijon

ZIP/Postal Code

21079

Country

France

Facility Name

Hopital de la croix rousse; Ophtalmologie

City

Lyon cedex

ZIP/Postal Code

69317

Country

France

Facility Name

CHNO des Quinze Vingts; Ophtalmologie

City

Paris

ZIP/Postal Code

75012

Country

France

Facility Name

Centre Ophtalmologique; Imagerie et laser

City

Paris

ZIP/Postal Code

75015

Country

France

Facility Name

Centres Ophtalmologique St Exupéry; Ophtalmologie

City

St Cyr Sur Loire

ZIP/Postal Code

37540

Country

France

Facility Name

Hôpital PURPAN - CHU TOULOUSE; Ophtalmologie

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

Universitätsklinikum Carl Gustav Carus, Klinik und Poliklinik für Augenheilkunde

City

Dresden

ZIP/Postal Code

01307

Country

Germany

Facility Name

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitätsklinikum des Saarlandes; Klinik für Augenheilkunde

City

Homburg/Saar

ZIP/Postal Code

66424

Country

Germany

Facility Name

Universitätsklinikum Magdeburg A.ö.R., Universitätsaugenklinik

City

Magdeburg

ZIP/Postal Code

39120

Country

Germany

Facility Name

LMU Klinikum der Universität, Augenklinik

City

München

ZIP/Postal Code

80336

Country

Germany

Facility Name

Klinikum rechts der Isar der TU München; Augenklinik

City

München

ZIP/Postal Code

81675

Country

Germany

Facility Name

Universitätsklinikum Würzburg, Augenklinik und Poliklinik

City

Würzburg

ZIP/Postal Code

97080

Country

Germany

Facility Name

Queen Mary Hospital; Department of Ophthalmology

City

Hong Kong

Country

Hong Kong

Facility Name

Hong Kong Eye Hospital; CUHK Eye Centre

City

Mongkok

Country

Hong Kong

Facility Name

Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály

City

Budapest

ZIP/Postal Code

1068

Country

Hungary

Facility Name

Peterfy Sandor utcai Korhaz-Rendelointezet es Baleseti Kozpont, Szemeszet KR

City

Budapest

ZIP/Postal Code

1076

Country

Hungary

Facility Name

Semmelweis Egyetem Szemészeti Vizsgálóhely

City

Budapest

ZIP/Postal Code

1085

Country

Hungary

Facility Name

Bajcsy-Zsilinszky Hospital

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche

City

Roma

State/Province

Lazio

ZIP/Postal Code

00133

Country

Italy

Facility Name

ASST FATEBENEFRATELLI SACCO; Oculistica (Sacco)

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20157

Country

Italy

Facility Name

Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica

City

Firenze

State/Province

Toscana

ZIP/Postal Code

50134

Country

Italy

Facility Name

Nuovo Ospedale S. Chiara - A.O.U.P Presidio Ospedaliero di Cisanello; U.O. Oculistica Universitaria

City

Pisa

State/Province

Toscana

ZIP/Postal Code

56124

Country

Italy

Facility Name

Ospedale Classificato Equiparato Sacro Cuore ? Don Calabria; Dipartimento Oculistica

City

Negrar - Verona

State/Province

Veneto

ZIP/Postal Code

37024

Country

Italy

Facility Name

A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica

City

Udine

State/Province

Veneto

ZIP/Postal Code

33100

Country

Italy

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

ZIP/Postal Code

463-707

Country

Korea, Republic of

Facility Name

Kyung Hee University Hospital

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Samsung Medical Center

City

Seoul

ZIP/Postal Code

135-710

Country

Korea, Republic of

Facility Name

Asan Medical Center.

City

Seoul

ZIP/Postal Code

5505

Country

Korea, Republic of

Facility Name

OFTALMIKA Sp. z o.o

City

Bydgoszcz

ZIP/Postal Code

85-631

Country

Poland

Facility Name

Specjalistyczny O?rodek Okulistyczny Oculomedica

City

Bydgoszcz

ZIP/Postal Code

85-870

Country

Poland

Facility Name

Optimum Profesorskie Centrum Okulistyki

City

Gda?sk

ZIP/Postal Code

80-809

Country

Poland

Facility Name

Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT

City

Gliwice

ZIP/Postal Code

44-100

Country

Poland

Facility Name

SP ZOZ Szpital Uniwersytecki w Krakowie Oddzia? Kliniczny Okulistyki i Onkologii Okulistycznej

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Osrodek Chirurgii Oka prof. Zagorskiego Rzeszow

City

Rzeszów

ZIP/Postal Code

35-017

Country

Poland

Facility Name

Caminomed

City

Tarnowskie Góry

ZIP/Postal Code

42-600

Country

Poland

Facility Name

Centrum Zdrowia MDM

City

Warszawa

ZIP/Postal Code

00-635

Country

Poland

Facility Name

Hospital de Braga; Servico de Oftalmologia

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

AIBILI - Association for Innovation and Biomedical Research on Light

City

Coimbra

ZIP/Postal Code

3000-548

Country

Portugal

Facility Name

Espaco Medico Coimbra

City

Coimbra

ZIP/Postal Code

3030-163

Country

Portugal

Facility Name

Hospital de Santa Maria; Servico de Oftalmologia

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Intersec Research and Technology Complex ?Eye Microsurgery? n.a. S.N. Fyodorov; Cheboksary Branch

City

Cheboksary

State/Province

Marij EL

ZIP/Postal Code

428000

Country

Russian Federation

Facility Name

Clinics of Eye Diseases, LLC

City

Kazan

State/Province

Tatarstan

ZIP/Postal Code

420066

Country

Russian Federation

Facility Name

?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch

City

Irkutsk

ZIP/Postal Code

664033

Country

Russian Federation

Facility Name

?Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch

City

Novosibirsk

ZIP/Postal Code

630096

Country

Russian Federation

Facility Name

National University Hospital; Ophthalmology Department

City

Singapore

ZIP/Postal Code

119074

Country

Singapore

Facility Name

Singapore Eye Research Institute

City

Singapore

ZIP/Postal Code

168751

Country

Singapore

Facility Name

Tan Tock Seng Hospital; Ophthalmology Department

City

Singapore

ZIP/Postal Code

308433

Country

Singapore

Facility Name

Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia

City

Oviedo

State/Province

Asturias

ZIP/Postal Code

33012

Country

Spain

Facility Name

Hospital Universitario de Bellvitge

City

Hospitalet de Llobregat

State/Province

Barcelona

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hospital General de Catalunya

City

San Cugat Del Valles

State/Province

Barcelona

ZIP/Postal Code

08195

Country

Spain

Facility Name

Complejo Hospitalario de Navarra; Servicio de oftalmologia

City

Pamplona

State/Province

Navarra

ZIP/Postal Code

31008

Country

Spain

Facility Name

Oftalvist Valencia

City

Burjassot

State/Province

Valencia

ZIP/Postal Code

46100

Country

Spain

Facility Name

Institut de la Macula i la retina

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Hospital dos de maig; Pharmacy Service

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Hospital Clinico San Carlos; Servicio de oftalmologia

City

Madrid

ZIP/Postal Code

28040

Country

Spain

Facility Name

Clinica Baviera; Servicio Oftalmologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Fisabio-Ofalmologia Medica; Servicio de Oftalmología

City

Valencia

ZIP/Postal Code

46015

Country

Spain

Facility Name

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

City

Valladolid

ZIP/Postal Code

47012

Country

Spain

Facility Name

Vista Klinik Ophthalmologische Klinik

City

Binningen

ZIP/Postal Code

4102

Country

Switzerland

Facility Name

Taipei Veterans General Hospital; Ophthalmology

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Medical Foundation - Linkou; Ophthalmology

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

National Taiwan University Hospital; Ophthalmology

City

Zhongzheng Dist.

ZIP/Postal Code

10002

Country

Taiwan

Facility Name

King Chulalongkorn Memorial Hospital; Ophthalmology Department

City

Bangkok

ZIP/Postal Code

10330

Country

Thailand

Facility Name

Rajavithi Hospital; Ophthalmology Department

City

Bangkok

ZIP/Postal Code

10400

Country

Thailand

Facility Name

Maharaj Nakorn ChiangMai Hospital; Ophthalmology Department

City

ChiangMai

ZIP/Postal Code

50200

Country

Thailand

Facility Name

Ankara University Medical Faculty; Department of Ophthalmology

City

Ankara

ZIP/Postal Code

06340

Country

Turkey

Facility Name

Ankara Baskent University Medical Faculty; Department of Ophthalmology

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Beyoglu Goz Training and Research Hospital; Department Of Ophthalmology

City

Istanbul

ZIP/Postal Code

34421

Country

Turkey

Facility Name

Kocaeli Üniversitesi T?p Fakültesi; Department of Ophthalmology

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Barnet Hospital; ROYAL FREE LONDON NHS FOUNDATION TRUST

City

Barnet

ZIP/Postal Code

EN5 3DJ

Country

United Kingdom

Facility Name

Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

Bradford Royal Infirmary

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

University Hospitals Bristol NHS Foundation Trust, Bristol Eye Hospital

City

Bristol

ZIP/Postal Code

BS1 2LX

Country

United Kingdom

Facility Name

East Kent Hospitals University NHS Foundation Trust

City

Canterbury

ZIP/Postal Code

CT1 3NG

Country

United Kingdom

Facility Name

Frimley Park Hospital

City

Frimley

ZIP/Postal Code

GU16 7UJ

Country

United Kingdom

Facility Name

Gloucestershire Hospitals NHS Foundation Trust

City

Gloucestershire

ZIP/Postal Code

GL1 3NN

Country

United Kingdom

Facility Name

St James University Hospital

City

Leeds

ZIP/Postal Code

LS9 7TF

Country

United Kingdom

Facility Name

Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre

City

Liverpool

ZIP/Postal Code

L7 8YE

Country

United Kingdom

Facility Name

Moorfields Eye Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

EC1V 2PD

Country

United Kingdom

Facility Name

Royal Free Hospital

City

London

ZIP/Postal Code

NW3 2QS

Country

United Kingdom

Facility Name

Kings College Hospital

City

London

ZIP/Postal Code

SW9 8RR

Country

United Kingdom

Facility Name

Manchester Royal Eye Hospital

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Hillingdon Hospital

City

Middx

ZIP/Postal Code

UB8 3NN

Country

United Kingdom

Facility Name

Royal Victoria Infirmary

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

James Paget University Hospitals NHS Foundation Trust

City

Norfolk

ZIP/Postal Code

NR31 6LA

Country

United Kingdom

Facility Name

University Hospital Southampton NHS Foundation Trust; Southampton Eye Unit

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Sunderland Eye Infirmary

City

Sunderland

ZIP/Postal Code

SR2 9HP

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Qualified researchers may request access to individual patient level data through the request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Citations:

PubMed Identifier

36246184

Citation

Eter N, Singh RP, Abreu F, Asik K, Basu K, Baumal C, Chang A, Csaky KG, Haskova Z, Lin H, Ruiz CQ, Ruamviboonsuk P, Silverman D, Wykoff CC, Willis JR. YOSEMITE and RHINE: Phase 3 Randomized Clinical Trials of Faricimab for Diabetic Macular Edema: Study Design and Rationale. Ophthalmol Sci. 2021 Dec 30;2(1):100111. doi: 10.1016/j.xops.2021.100111. eCollection 2022 Mar.

Results Reference

derived

PubMed Identifier

35085503

Citation

Wykoff CC, Abreu F, Adamis AP, Basu K, Eichenbaum DA, Haskova Z, Lin H, Loewenstein A, Mohan S, Pearce IA, Sakamoto T, Schlottmann PG, Silverman D, Sun JK, Wells JA, Willis JR, Tadayoni R; YOSEMITE and RHINE Investigators. Efficacy, durability, and safety of intravitreal faricimab with extended dosing up to every 16 weeks in patients with diabetic macular oedema (YOSEMITE and RHINE): two randomised, double-masked, phase 3 trials. Lancet. 2022 Feb 19;399(10326):741-755. doi: 10.1016/S0140-6736(22)00018-6. Epub 2022 Jan 24.

Results Reference

derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Participants With Diabetic Macular Edema

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