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A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Primary Purpose

Wet Macular Degeneration

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Faricimab

Aflibercept

Sham Procedure

About this trial

This is an interventional treatment trial for Wet Macular Degeneration focused on measuring AMD, nAMD, neovascular age-related macular degeneration, choroidal neovascularization secondary to age-related macular degeneration

Eligibility Criteria

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

Inclusion Criteria:

Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye
Ability to comply with the study protocol, in the investigator's judgment
For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment
Other protocol-specified inclusion criteria may apply

Exclusion Criteria:

Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1
Pregnancy or breastfeeding, or intention to become pregnant during the study
CNV due to causes other than AMD in the study eye
Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye
Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study
Uncontrolled glaucoma in the study eye
Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye
Prior IVT administration of faricimab in either eye
History of idiopathic or autoimmune-associated uveitis in either eye
Active ocular inflammation or suspected or active ocular or periocular infection in either eye
Other protocol-specified exclusion criteria may apply

Sites / Locations

Associated Retina Consultants
Arizona Retina and Vitreous Consultants
Northern California Retina Vitreous Associates
Retinal Consultants Med Group
Orange County Retina Med Group
California Retina Consultants
Colorado Retina Associates, PC
Retina Group of Florida
Retina Care Specialists
Southern Vitreoretinal Assoc
Retina Associates of Florida, LLC
Southeast Retina Center
Georgia Retina PC
Retina Consultants of Hawaii
University Retina and Macula Associates, PC
Prairie Retina Center
Raj K. Maturi, MD PC
Wolfe Eye Clinic
Maine Eye Center
The Retina Care Center
Cumberland Valley Retina PC
Retina Specialists
Ophthalmic Consultants of Boston
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Island Retina
Retina Assoc of Cleveland Inc
The Ohio State University Havener Eye Institute
Midwest Retina
Mid Atlantic Retina - Wills Eye Hospital
Palmetto Retina Center
Southeastern Retina Associates Chattanooga
Retina Res Institute of Texas
Austin Retina Associates
Austin Clinical Research LLC
Retina Specialists
Retina Center of Texas
Retina Consultants of Houston
Strategic Clinical Research Group, LLC
Retina Associates of Utah
Piedmont Eye Center
Wagner Macula & Retina Center
Retina Center Northwest
Fundacion Zambrano
Centro Oftalmológico Dr. Charles S.A.
Oftalmos
Buenos Aires Mácula
Oftar
Grupo Laser Vision
Organizacion Medica de Investigacion
Eyeclinic Albury Wodonga
Marsden Eye Research Centre
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
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie
Hospital de Olhos de Aparecida - HOA
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
Pentagram Eye Hospital (Medical Center "Pentagram")
Specialized Hospital for Active Treatment of Eye Diseases Zora
Peking Union Medical College Hospital
Beijing Friendship Hospital
Beijing Tongren Hospital
The Second Hospital of Jilin University; ophthalmology department
West China Hospital, Sichuan University
Southwest Hospital , Third Military Medical University; Ophthalmology
Daping Hospital of Third Military Medical University
Zhongshan Ophthalmic Center, Sun Yat-sen University
The Second Affiliated Hospital of Harbin Medical University; ophthalmology department
The Affiliated Eye Hospital of Nanjing Medical University
Shanghai First People's Hospital
He Eye Specialist Shenyang Hospital
Tianjin Eye Hospital
Eye Hospital, Wenzhou Medical University
Wuxi No.2 People's Hospital
Rigshospitalet Glostrup; Afdeling for Øjensygdomme, Center for Forskning
Sjællands Universitetshospital, Roskilde; Øjenafdelingen
Chi De Creteil; Ophtalmologie
Pole Vision Val d'Ouest; Ophtalmologie
Hopital de la croix rousse; Ophtalmologie
Centre Paradis Monticelli; Ophtalmologie
CHU Nantes - Hôtel Dieu; Ophthalmology
Centre Odeon; Exploration Ophtalmologique
Hopital Lariboisiere; Ophtalmologie
Centre Ophtalmologique; Imagerie et laser
Centres Ophtalmologique St Exupéry; Ophtalmologie
Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde
Universitätsklinikum Köln; Augenklinik
Augenabteilung am St. Franziskus-Hospital
Universitätsklinikum Münster; Augenheilkunde
Queen Mary Hospital; Department of Ophthalmology
Hong Kong Eye Hospital; CUHK Eye Centre
Magyar Honvedseg Egeszsegugyi Kozpont; Szemészeti Osztály
Bajcsy-Zsilinszky Hospital
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA
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
A.O. Universitaria S. Maria Della Misericordia Di Udine; Clinica Oculistica
Pusan National University Hospital
Yeungnam University Medical Center
Seoul National University Bundang Hospital
Kyung Hee University Hospital
Seoul National University Hospital
Nune Eye Hospital; Ophthalmology
Samsung Medical Center
Asan Medical Center.
OFTALMIKA Sp. z o.o
Optimum Profesorskie Centrum Okulistyki
SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej
Caminomed
Hospital de Braga; Servico de Oftalmologia
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
Hospital de Sao Joao; Servico de Oftalmologia
Intersec Research and Technology Complex "Eye Microsurgery" n.a. S.N. Fyodorov; Cheboksary Branch
"Intersec. Research and Technology Complex "Eye Microsurgery" n a Fyodorov Irkutsk branch
"Intersec Research and Technology Complex Eye Microsurgery n a Fyodorov Novosibirsk Branch
1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology
National University Hospital; Ophthalmology Department
Singapore Eye Research Institute
Instituto Oftalmologico Fernandez Vega; Servicio de oftalmologia
Hospital Universitario de Bellvitge
Institut de la Macula i la retina
Hospital Clinic de Barcelona; Consultas Externas Oftalmologia
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Hospital Universitario Miguel Servet; Servicio de Oftalmologia
Changhua Christian Hospital; Department of Ophthalmology
Taipei Veterans General Hospital; Ophthalmology
Chang Gung Medical Foundation - Linkou; Ophthalmology
Hacettepe University Medical Faculty; Department of Ophthalmology
Ankara University Medical Faculty; Department of Ophthalmology
Gazi University Faculty of Medicine; Department Of Ophthalmology
Ege University Medical Faculty; Department of Ophthalmology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm A: Faricimab

Arm B: Aflibercept

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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 from baseline indicates an improvement in visual acuity. The Mixed Model of Repeated Measures (MMRM) analysis adjusted for treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), baseline BCVA (≥74, 73-55, and ≤54 letters), baseline LLD (<33 and ≥33 letters), and region (U.S. and Canada, Asia, and rest of the world). An unstructured covariance structure was used. Treatment policy strategy (i.e., all observed values used) and hypothetical strategy (i.e., all values censored after 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% CI is a rounding of 95.03% CI.

Secondary Outcome Measures

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Change From Baseline in BCVA in the Study Eye Over Time

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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 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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

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

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 percentage of participants avoiding a loss of letters in BCVA from baseline was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

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

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

Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA or Achieving BCVA Snellen Equivalent of 20/20 or Better (BCVA ≥84 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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 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 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 48. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 60. The treatment interval at a given visit is defined as the treatment interval decision followed at that visit. The 95% confidence interval (CI) is a rounding of 95.03% CI.

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112

Percentages are based on the number of participants randomized to the faricimab arm who have not discontinued the study at Week 112. Treatment interval at a given visit is defined as the treatment interval decision followed at that visit. Treatment interval at Week 112 is calculated using data recorded at Week 108. The 95% confidence interval (CI) is a rounding of 95.03% CI.

Number of Study Drug Injections Received in the Study Eye Through Week 48

Number of Study Drug Injections Received in the Study Eye Through Week 60

Number of Study Drug Injections Received in the Study Eye Through Week 108

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group iteraction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.

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

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.

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

Intraretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 millimetre [mm]). The weighted estimates of the percentage of participants with absence of intraretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), 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 95.03% CI.

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

Subretinal fluid was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), 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 95.03% CI.

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

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 with absence of intraretinal and subretinal fluid were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), 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 95.03% CI.

Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time

Pigment epithelial detachment was measured using optical coherence tomography (OCT) in the central subfield (center 1 mm). The weighted estimates of the percentage of participants with absence of pigment epithelial detachment were based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 letters), 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 95.03% CI.

Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time

Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

The total area of the choroidal neovascularization lesion in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.

Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112

Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48

The total area of choroidal neovascularization leakage in the study eye was evaluated by a central reading center using fundus fluorescein angiography (FFA). Assessments were censored following COVID-19 related intercurrent events. Baseline was defined as the last available measurement obtained on or prior to randomization.

Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112

Percentage of Participants With at Least One Adverse Event

This analysis of adverse events (AEs) includes both ocular and non-ocular (systemic) AEs. Multiple occurrences of the same AE in one individual are counted only once. 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 (IOI).

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. Multiple occurrences of the same AE in one individual are counted only once. 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. Multiple occurrences of the same AE in one individual are counted only once. 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. 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 Tested 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

NCT03823300

First Posted

January 29, 2019

Last Updated

December 16, 2022

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03823300

Brief Title

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

Official Title

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (LUCERNE)

Study Type

Interventional

2. Study Status

Record Verification Date

December 2022

Overall Recruitment Status

Completed

Study Start Date

March 11, 2019 (Actual)

Primary Completion Date

October 5, 2020 (Actual)

Study Completion Date

January 7, 2022 (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

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

This study will evaluate the efficacy, safety, durability, and pharmacokinetics of faricimab administered at intervals as specified in the protocol, compared with aflibercept once every 8 weeks (Q8W), in participants with neovascular age-related macular degeneration (nAMD).

6. Conditions and Keywords

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

Wet Macular Degeneration

Keywords

AMD, nAMD, neovascular age-related macular degeneration, choroidal neovascularization secondary to age-related macular degeneration

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

658 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm A: Faricimab

Arm Type

Experimental

Arm Title

Arm B: Aflibercept

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Faricimab

Other Intervention Name(s)

VABYSMO™, RO6867461, RG7716

Intervention Description

Faricimab will be administered by intravitreal injection into the study eye at intervals as specified in the study protocol.

Intervention Type

Drug

Intervention Name(s)

Aflibercept

Other Intervention Name(s)

Eylea

Intervention Description

Aflibercept will be administered by intravitreal injection into the study eye once every 4 weeks for 3 consecutive months, followed by once every 8 weeks (Q8W).

Intervention Type

Procedure

Intervention Name(s)

Sham Procedure

Intervention Description

The sham is a procedure that mimics an intravitreal injection, but involves the blunt end of an empty syringe (without a needle) being pressed against the anesthetized eye. It will be administered to participants in both treatment arms at applicable visits to maintain masking.

Primary Outcome Measure Information:

Title

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Description

Time Frame

From Baseline through Week 48

Secondary Outcome Measure Information:

Title

Change From Baseline in BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Description

Time Frame

From Baseline through Week 60

Title

Change From Baseline in BCVA in the Study Eye Over Time

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, 100, 104, 108, and 112

Title

Percentage of Participants Gaining Greater Than or Equal to (≥)15, ≥10, ≥5, or ≥0 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Description

Time Frame

Baseline, average of Weeks 40, 44, and 48

Title

Percentage of Participants Gaining ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Description

Time Frame

Baseline, average of Weeks 52, 56, and 60

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

Percentage of Participants Avoiding a Loss of ≥15, ≥10, or ≥5 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 40, 44, and 48

Description

Time Frame

Baseline, average of Weeks 40, 44, and 48

Title

Percentage of Participants Avoiding a Loss of ≥15 Letters From the Baseline BCVA in the Study Eye Averaged Over Weeks 52, 56, and 60

Description

Time Frame

Baseline, average of Weeks 52, 56, and 60

Title

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

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, 100, 104, 108, and 112

Title

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

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, 100, 104, 108, and 112

Title

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

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, 100, 104, 108, and 112

Title

Description

Time Frame

Baseline, average of Weeks 40, 44, and 48

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better (BCVA ≥69 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

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 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 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 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 95.03% CI.

Time Frame

Baseline, average of Weeks 40, 44, and 48

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (<69 letters vs. ≥69 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (BCVA ≤38 Letters) in the Study Eye Averaged Over Weeks 40, 44, and 48

Description

Time Frame

Baseline, average of Weeks 40, 44, and 48

Title

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

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 percentage of participants was based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (≥33 letters and <33 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 95.03% 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, 100, 104, 108, and 112

Title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 48

Description

Time Frame

Week 48

Title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 60

Description

Time Frame

Week 60

Title

Percentage of Participants in the Faricimab Arm on Once Every 8-Weeks, 12-Weeks, or 16-Weeks Treatment Intervals Among Those Completing Week 112

Description

Time Frame

Weeks 108 and 112

Title

Number of Study Drug Injections Received in the Study Eye Through Week 48

Time Frame

From Baseline through Week 48

Title

Number of Study Drug Injections Received in the Study Eye Through Week 60

Time Frame

From Baseline through Week 60

Title

Number of Study Drug Injections Received in the Study Eye Through Week 108

Time Frame

From Baseline through Week 108

Title

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 40, 44, and 48

Description

Time Frame

From Baseline through Week 48

Title

Change From Baseline in Central Subfield Thickness in the Study Eye Averaged Over Weeks 52, 56, and 60

Description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% CI.

Time Frame

From Baseline through Week 60

Title

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

Description

Central subfield thickness (CST) was defined as the distance between the internal limiting membrane (ILM) and the retinal pigment epithelium (RPE) using optical coherence tomography (OCT), as assessed by the central reading center. For the Mixed Model of Repeated Measures (MMRM) analysis, the model adjusted for treatment group, visit, visit-by-treatment group interaction, baseline CST (continuous), baseline BCVA (≥74 letters, 73-55 letters, and ≤54 letters), baseline LLD (<33 letters and ≥33 letters), and region (U.S. and Canada, Asia, and the rest of the world). 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 95.03% 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, 100, 104, 108, and 112

Title

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

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

Title

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

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

Title

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

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

Title

Percentage of Participants With Absence of Pigment Epithelial Detachment in the Study Eye Over Time

Description

Time Frame

Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 104, 108, and 112

Title

Percentage of Participants With Absence of Intraretinal Cysts in the Study Eye Over Time

Time Frame

Up to 112 weeks

Title

Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 48

Description

Time Frame

Baseline and Week 48

Title

Change From Baseline in Total Area of Choroidal Neovascularization Lesion in the Study Eye at Week 112

Description

Time Frame

Baseline and Week 112

Title

Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 48

Description

Time Frame

Baseline and Week 48

Title

Change From Baseline in Total Area of Choroidal Neovascularization Leakage in the Study Eye at Week 112

Description

Time Frame

Baseline and Week 112

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 112 weeks)

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 112 weeks)

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 112 weeks)

Title

Plasma Concentration of Faricimab Over Time

Description

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

Time Frame

Pre-dose at Baseline, Weeks 4, 16, 20, 48, 76, and 112

Title

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

Description

Time Frame

Pre-dose at Baseline, Weeks 4, 20, 48, 76, and 112

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Treatment-naïve choroidal neovascularization (CNV) secondary to age-related macular degeneration (nAMD) in the study eye Ability to comply with the study protocol, in the investigator's judgment For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use acceptable contraceptive measures that result in failure rate <1% per year during the treatment period and for at least 3 months after the final dose of study treatment Other protocol-specified inclusion criteria may apply Exclusion Criteria: Uncontrolled blood pressure, defined as systolic blood pressure >180 millimeters of mercury (mmHg) and/or diastolic blood pressure >100 mmHg while a patient is at rest on Day 1 Pregnancy or breastfeeding, or intention to become pregnant during the study CNV due to causes other than AMD in the study eye Any history of macular pathology unrelated to AMD affecting vision or contributing to the presence of intraretinal or subretinal fluid in the study eye Any concurrent intraocular condition in the study eye that, in the opinion of the investigator, could either reduce the potential for visual improvement or require medical or surgical intervention during the study Uncontrolled glaucoma in the study eye Any prior or concomitant treatment for CNV or vitreomacular-interface abnormalities in the study eye Prior IVT administration of faricimab in either eye History of idiopathic or autoimmune-associated uveitis in either eye Active ocular inflammation or suspected or active ocular or periocular infection in either eye Other protocol-specified 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

Associated Retina Consultants

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85020

Country

United States

Facility Name

Arizona Retina and Vitreous Consultants

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85021

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

Orange County Retina Med Group

City

Santa Ana

State/Province

California

ZIP/Postal Code

92705

Country

United States

Facility Name

California Retina Consultants

City

Santa Barbara

State/Province

California

ZIP/Postal Code

93103

Country

United States

Facility Name

Colorado Retina Associates, PC

City

Lakewood

State/Province

Colorado

ZIP/Postal Code

80228

Country

United States

Facility Name

Retina Group of Florida

City

Fort Lauderdale

State/Province

Florida

ZIP/Postal Code

33308

Country

United States

Facility Name

Retina Care Specialists

City

Palm Beach Gardens

State/Province

Florida

ZIP/Postal Code

33410

Country

United States

Facility Name

Southern Vitreoretinal Assoc

City

Tallahassee

State/Province

Florida

ZIP/Postal Code

32308

Country

United States

Facility Name

Retina Associates of Florida, LLC

City

Tampa

State/Province

Florida

ZIP/Postal Code

33609

Country

United States

Facility Name

Southeast Retina Center

City

Augusta

State/Province

Georgia

ZIP/Postal Code

30909

Country

United States

Facility Name

Georgia Retina PC

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060-1137

Country

United States

Facility Name

Retina Consultants of Hawaii

City

'Aiea

State/Province

Hawaii

ZIP/Postal Code

96701

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

Raj K. Maturi, MD PC

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46290

Country

United States

Facility Name

Wolfe Eye Clinic

City

West Des Moines

State/Province

Iowa

ZIP/Postal Code

50266

Country

United States

Facility Name

Maine Eye Center

City

Portland

State/Province

Maine

ZIP/Postal Code

04101

Country

United States

Facility Name

The Retina Care Center

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21209

Country

United States

Facility Name

Cumberland Valley Retina PC

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Retina Specialists

City

Towson

State/Province

Maryland

ZIP/Postal Code

21204

Country

United States

Facility Name

Ophthalmic Consultants of Boston

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota

City

Edina

State/Province

Minnesota

ZIP/Postal Code

55435

Country

United States

Facility Name

Island Retina

City

Shirley

State/Province

New York

ZIP/Postal Code

11967

Country

United States

Facility Name

Retina Assoc of Cleveland Inc

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44122

Country

United States

Facility Name

The Ohio State University Havener Eye Institute

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43212

Country

United States

Facility Name

Midwest Retina

City

Dublin

State/Province

Ohio

ZIP/Postal Code

43016

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

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

Retina Res Institute of Texas

City

Abilene

State/Province

Texas

ZIP/Postal Code

79606

Country

United States

Facility Name

Austin Retina Associates

City

Austin

State/Province

Texas

ZIP/Postal Code

78705-1169

Country

United States

Facility Name

Austin Clinical Research LLC

City

Austin

State/Province

Texas

ZIP/Postal Code

78750

Country

United States

Facility Name

Retina Specialists

City

DeSoto

State/Province

Texas

ZIP/Postal Code

75115

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 Houston

City

The Woodlands

State/Province

Texas

ZIP/Postal Code

77384

Country

United States

Facility Name

Strategic Clinical Research Group, LLC

City

Willow Park

State/Province

Texas

ZIP/Postal Code

76087

Country

United States

Facility Name

Retina Associates of Utah

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Piedmont Eye Center

City

Lynchburg

State/Province

Virginia

ZIP/Postal Code

24502

Country

United States

Facility Name

Wagner Macula & Retina Center

City

Norfolk

State/Province

Virginia

ZIP/Postal Code

23502

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

Centro Oftalmológico Dr. Charles S.A.

City

Capital Federal

ZIP/Postal Code

C1015ABO

Country

Argentina

Facility Name

Oftalmos

City

Capital Federal

ZIP/Postal Code

C1120AAN

Country

Argentina

Facility Name

Buenos Aires Mácula

City

Ciudad Autonoma Buenos Aires

ZIP/Postal Code

C1061AAE

Country

Argentina

Facility Name

Oftar

City

Mendoza

ZIP/Postal Code

M5500GGK

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

Eyeclinic Albury Wodonga

City

Albury

State/Province

New South Wales

ZIP/Postal Code

2640

Country

Australia

Facility Name

Marsden Eye Research Centre

City

Parramatta

State/Province

New South Wales

ZIP/Postal Code

2150

Country

Australia

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

LKH-Univ.Klinikum Graz; Universitäts-Augenklinik

City

Graz

ZIP/Postal Code

8036

Country

Austria

Facility Name

Medizinische Universität Wien; Universitätsklinik für Augenheilkunde und Optometrie

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

Hospital de Olhos de Aparecida - HOA

City

Aparecida de Goiania

State/Province

ZIP/Postal Code

74980-010

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

Pentagram Eye Hospital (Medical Center "Pentagram")

City

Sofia

ZIP/Postal Code

1309

Country

Bulgaria

Facility Name

Specialized Hospital for Active Treatment of Eye Diseases Zora

City

Sofia

ZIP/Postal Code

1784

Country

Bulgaria

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; ophthalmology department

City

Changchun City

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

Daping Hospital of Third Military Medical University

City

Chongqing

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 Second Affiliated Hospital of Harbin Medical University; ophthalmology department

City

Harbin

ZIP/Postal Code

150081

Country

China

Facility Name

The Affiliated Eye Hospital of Nanjing Medical University

City

Nanjing City

ZIP/Postal Code

210029

Country

China

Facility Name

Shanghai First People's Hospital

City

Shanghai

ZIP/Postal Code

200080

Country

China

Facility Name

He Eye Specialist Shenyang Hospital

City

Shenyang City

ZIP/Postal Code

110034

Country

China

Facility Name

Tianjin Eye Hospital

City

Tianjin City

ZIP/Postal Code

300050

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

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

Pole Vision Val d'Ouest; Ophtalmologie

City

Ecully

ZIP/Postal Code

69130

Country

France

Facility Name

Hopital de la croix rousse; Ophtalmologie

City

Lyon cedex

ZIP/Postal Code

69317

Country

France

Facility Name

Centre Paradis Monticelli; Ophtalmologie

City

Marseille

ZIP/Postal Code

13008

Country

France

Facility Name

CHU Nantes - Hôtel Dieu; Ophthalmology

City

Nantes

ZIP/Postal Code

44093

Country

France

Facility Name

Centre Odeon; Exploration Ophtalmologique

City

Paris

ZIP/Postal Code

75006

Country

France

Facility Name

Hopital Lariboisiere; Ophtalmologie

City

Paris

ZIP/Postal Code

75010

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

Universitätkslinikum Düsseldorf, Augenklinik; Klinik fürAugenheilkunde

City

Düsseldorf

ZIP/Postal Code

40225

Country

Germany

Facility Name

Universitätsklinikum Köln; Augenklinik

City

Köln

ZIP/Postal Code

50937

Country

Germany

Facility Name

Augenabteilung am St. Franziskus-Hospital

City

Münster

ZIP/Postal Code

48145

Country

Germany

Facility Name

Universitätsklinikum Münster; Augenheilkunde

City

Münster

ZIP/Postal Code

48149

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

Bajcsy-Zsilinszky Hospital

City

Budapest

ZIP/Postal Code

1106

Country

Hungary

Facility Name

Szegedi Tudományegyetem ÁOK; Department of Ophtalmology

City

Szeged

ZIP/Postal Code

6720

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

UNIVERSITA' DEGLI STUDI DI GENOVA - Di.N.O.G.;CLINICA OCULISTICA

City

Genova

State/Province

Liguria

ZIP/Postal Code

16132

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

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

City

Udine

State/Province

Veneto

ZIP/Postal Code

33100

Country

Italy

Facility Name

Pusan National University Hospital

City

Busan

ZIP/Postal Code

602-739

Country

Korea, Republic of

Facility Name

Yeungnam University Medical Center

City

Daegu

ZIP/Postal Code

42415

Country

Korea, Republic of

Facility Name

Seoul National University Bundang Hospital

City

Seongnam-si

ZIP/Postal Code

13620

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

Nune Eye Hospital; Ophthalmology

City

Seoul

ZIP/Postal Code

06192

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

Optimum Profesorskie Centrum Okulistyki

City

Gdańsk

ZIP/Postal Code

80-809

Country

Poland

Facility Name

SP ZOZ Szpital Uniwersytecki w Krakowie Oddział Kliniczny Okulistyki i Onkologii Okulistycznej

City

Krakow

ZIP/Postal Code

31-501

Country

Poland

Facility Name

Caminomed

City

Tarnowskie Góry

ZIP/Postal Code

42-600

Country

Poland

Facility Name

Hospital de Braga; Servico de Oftalmologia

City

Braga

ZIP/Postal Code

4710-243

Country

Portugal

Facility Name

Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Hospital de Sao Joao; Servico de Oftalmologia

City

Porto

ZIP/Postal Code

4200-319

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

"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

1 Saint-Petersburg St. Med. University named after academician I.P.Pavlov; Chair of ophathalmology

City

Saint Petersburg

ZIP/Postal Code

197022

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

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

Institut de la Macula i la retina

City

Barcelona

ZIP/Postal Code

08022

Country

Spain

Facility Name

Hospital Clinic de Barcelona; Consultas Externas Oftalmologia

City

Barcelona

ZIP/Postal Code

08028

Country

Spain

Facility Name

Hospital Universitario Rio Hortega; Servicio de Oftalmologia

City

Valladolid

ZIP/Postal Code

47012

Country

Spain

Facility Name

Hospital Universitario Miguel Servet; Servicio de Oftalmologia

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Changhua Christian Hospital; Department of Ophthalmology

City

Changhua

ZIP/Postal Code

500

Country

Taiwan

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

Hacettepe University Medical Faculty; Department of Ophthalmology

City

Ankara

ZIP/Postal Code

06100

Country

Turkey

Facility Name

Ankara University Medical Faculty; Department of Ophthalmology

City

Ankara

ZIP/Postal Code

06340

Country

Turkey

Facility Name

Gazi University Faculty of Medicine; Department Of Ophthalmology

City

Ankara

ZIP/Postal Code

06560

Country

Turkey

Facility Name

Ege University Medical Faculty; Department of Ophthalmology

City

Izmir

ZIP/Postal Code

35100

Country

Turkey

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

36246941

Citation

Khanani AM, Guymer RH, Basu K, Boston H, Heier JS, Korobelnik JF, Kotecha A, Lin H, Silverman D, Swaminathan B, Willis JR, Yoon YH, Quezada-Ruiz C. TENAYA and LUCERNE: Rationale and Design for the Phase 3 Clinical Trials of Faricimab for Neovascular Age-Related Macular Degeneration. Ophthalmol Sci. 2021 Nov 17;1(4):100076. doi: 10.1016/j.xops.2021.100076. eCollection 2021 Dec.

Results Reference

derived

PubMed Identifier

35085502

Citation

Heier JS, Khanani AM, Quezada Ruiz C, Basu K, Ferrone PJ, Brittain C, Figueroa MS, Lin H, Holz FG, Patel V, Lai TYY, Silverman D, Regillo C, Swaminathan B, Viola F, Cheung CMG, Wong TY; TENAYA and LUCERNE Investigators. Efficacy, durability, and safety of intravitreal faricimab up to every 16 weeks for neovascular age-related macular degeneration (TENAYA and LUCERNE): two randomised, double-masked, phase 3, non-inferiority trials. Lancet. 2022 Feb 19;399(10326):729-740. doi: 10.1016/S0140-6736(22)00010-1. Epub 2022 Jan 24.

Results Reference

derived

Learn more about this trial

A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Neovascular Age-Related Macular Degeneration (LUCERNE)

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