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

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

Barnet Dulaney Perkins Eye Center
Retinal Research Institute, LLC
Retina Associates Southwest PC
Retinal Diagnostic Center
The Retina Partners
Jacobs Retina center at the Shiley eye Institute UCSD
South Coast Retina Center
Southern CA Desert Retina Cons
California Eye Specialists Medical group Inc.
Retina Consultants, San Diego
Retina Consultants of Southern California
University of California, Davis, Eye Center
Retina Consultants of Southern
Retina Group of New England
Rand Eye
Florida Eye Associates
Retina Specialty Institute
Fort Lauderdale Eye Institute
Retina Vitreous Assoc of FL
Northwestern Medical Group/Northwestern University
Retina Associates
Johns Hopkins Med; Wilmer Eye Inst
Retina Group of Washington
Tufts Medical Center; Ophthalmology
Associated Retinal Consultants
Midwest Vision Research Foundation
Retina Associates of St. Louis
Sierra Eye Associates
NJ Retina
Retina Associates of NJ
Long Is. Vitreoretinal Consult
Retina Vit Surgeons/Central NY
Ophthalmic Cons of Long Island
Retina Assoc of Western NY
The Retina Consultants
Western Carolina Retinal Associate PA
Char Eye Ear &Throat Assoc
Graystone Eye
Carolina Eye Associates
Cincinnati Eye Institute
Retina Northwest
Mid Atlantic Retina - Wills Eye Hospital
Charleston Neuroscience Inst
Black Hills Eye Institute
Charles Retina Institute
Tennessee Retina PC.
Texas Retina Associates
Valley Retina Institute P.A.
Retina & Vitreous of Texas
Retina Consultants of Texas
Rocky Mountain Retina
Spokane Eye Clinical Research
Calgary Retina Consultants
University of British Columbia - Vancouver Coastal Health Authority
Ivey Eye Institute
University of Ottawa Eye Institute
The Retina Centre of Ottawa
Toronto Retina Institute
Unity Health Toronto
Institut De L'Oeil Des Laurentides
Michel Giunta Clinique Medical
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Universitätsklinik Heidelberg; Augenklinik
Universitätsklinikum Tübingen
Budapest Retina Associates Kft.
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Ganglion Medial Center
Zala Megyei Kórház; SZEMESZET
Rambam Medical Center; Opthalmology
Hadassah MC; Ophtalmology
Rabin MC; Ophtalmology
Kaplan Medical Center; Ophtalmology
Tel Aviv Sourasky MC; Ophtalmology
Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica
Chukyo Hospital
Nagoya University Hospital
Nagoya City University Hospital
Aichi Medical University Hospital
Daiyukai Daiichi Hospital
Chiba University Hospital
Toho University Sakura Medical Center
Hayashi Eye Hospital
Kurume University Hospital
Fukushima Medical University Hospital
Southern TOHOKU Eye Clinic
Sapporo City General Hospital
Hokkaido University Hospital
Asahikawa Medical University Hospital
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Hyogo Medical University Hospital
Kozawa eye hospital and diabetes center
Kagawa University Hospital
Kagoshima University Hospital
Ideta Eye Hospital
Kyoto University Hospital
Mie University Hospital
University of Miyazaki Hospital
Shinshu University Hospital
Iida Municipal Hospital
Japanese Red Cross Nagasaki Genbaku Hospital
Nara Medical University Hospital
University of the Ryukyus Hospital
Kitano Hospital
Osaka Metropolitan University Hospital
Kansai Medical University Medical Center
Kansai Medical University Hospital
National Defense Medical College Hospital
Shiga University Of Medical Science Hospital
Tokushima University Hospital
Nihon University Hospital
Takeuchi eye clinic
Tokyo Women's Medical University Hospital
Kyorin University Hospital
Tokyo Medical University Hachioji Medical Center
Yamaguchi University Hospital
Centro Oftalmológico Mira, S.C
Macula Retina Consultores
Montemayor & Asociados (Oftalmologos)
Het Oogziekenhuis Rotterdam
ETZ Elisabeth
Szpital sw. Lukasza
Specjalistyczny Ośrodek Okulistyczny Oculomedica
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Dobry Wzrok Sp Z O O
Gabinet Okulistyczny Prof Edward Wylegala
Centrum Medyczne Dietla 19 Sp. Z O.O.
SPEKTRUM Osrodek Okulistyki Klinicznej
Medical Military Academy n.a S.M.Kirov
Clinics of Eye Diseases, LLC
FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences
Hospital General de Catalunya
Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia
Hospital Universitario Puerta de Hierro
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Oftalvist Valencia
Hospital dos de maig; servicio de oftalmologia
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Clinica Baviera; Servicio Oftalmologia
Vista Klinik Ophthalmologische Klinik
Stadtspital Triemli Ophthalmologische Klinik
Ankara Baskent University Medical Faculty; Department of Ophthalmology
Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology
Selcuk University Faculty of Medicine; Department Of Ophthalmology
Bradford Royal Infirmary
Bristol Eye Hospital
University Hospital of Wales
Frimley Park Hospital
Gloucestershire Royal Hospital
Hull Royal Infirmary
St James University Hospital
Royal Liverpool University Hospital; St Paul's Clinical Eye Research Centre
Moorfields Eye Hospital NHS Foundation Trust
Royal Free Hospital
Manchester Royal Infirmary
Royal Victoria Infirmary
Southampton General Hospital
New Cross Hospital
The York Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Faricimab

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 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 Averaged Over Weeks 52, 56, and 60

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

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 millimetre [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

NCT03823287

First Posted

January 29, 2019

Last Updated

January 16, 2023

Sponsor

Hoffmann-La Roche

1. Study Identification

Unique Protocol Identification Number

NCT03823287

Brief Title

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

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 (TENAYA)

Study Type

Interventional

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Completed

Study Start Date

February 19, 2019 (Actual)

Primary Completion Date

October 26, 2020 (Actual)

Study Completion Date

January 18, 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

671 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Faricimab

Arm Type

Experimental

Arm Title

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 treatments 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

Time Frame

From Baseline through Week 60

Title

Change From Baseline in Central Subfield Thickness 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 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

Barnet Dulaney Perkins Eye Center

City

Mesa

State/Province

Arizona

ZIP/Postal Code

85206

Country

United States

Facility Name

Retinal Research Institute, LLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85014

Country

United States

Facility Name

Retina Associates Southwest PC

City

Tucson

State/Province

Arizona

ZIP/Postal Code

85704

Country

United States

Facility Name

Retinal Diagnostic Center

City

Campbell

State/Province

California

ZIP/Postal Code

95008

Country

United States

Facility Name

The Retina Partners

City

Encino

State/Province

California

ZIP/Postal Code

91436

Country

United States

Facility Name

Jacobs Retina center at the Shiley eye Institute UCSD

City

La Jolla

State/Province

California

ZIP/Postal Code

92037

Country

United States

Facility Name

South Coast Retina Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Facility Name

Southern CA Desert Retina Cons

City

Palm Desert

State/Province

California

ZIP/Postal Code

92211

Country

United States

Facility Name

California Eye Specialists Medical group Inc.

City

Pasadena

State/Province

California

ZIP/Postal Code

91107

Country

United States

Facility Name

Retina Consultants, San Diego

City

Poway

State/Province

California

ZIP/Postal Code

92064

Country

United States

Facility Name

Retina Consultants of Southern California

City

Redlands

State/Province

California

ZIP/Postal Code

92373

Country

United States

Facility Name

University of California, Davis, Eye Center

City

Sacramento

State/Province

California

ZIP/Postal Code

95817

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

Rand Eye

City

Deerfield Beach

State/Province

Florida

ZIP/Postal Code

33064

Country

United States

Facility Name

Florida Eye Associates

City

Melbourne

State/Province

Florida

ZIP/Postal Code

32901

Country

United States

Facility Name

Retina Specialty Institute

City

Pensacola

State/Province

Florida

ZIP/Postal Code

32503

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

Northwestern Medical Group/Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Retina Associates

City

Lenexa

State/Province

Kansas

ZIP/Postal Code

66215

Country

United States

Facility Name

Johns Hopkins Med; Wilmer Eye Inst

City

Baltimore

State/Province

Maryland

ZIP/Postal Code

21287

Country

United States

Facility Name

Retina Group of Washington

City

Chevy Chase

State/Province

Maryland

ZIP/Postal Code

20815

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

Midwest Vision Research Foundation

City

Chesterfield

State/Province

Missouri

ZIP/Postal Code

63017

Country

United States

Facility Name

Retina Associates of St. Louis

City

Florissant

State/Province

Missouri

ZIP/Postal Code

63031

Country

United States

Facility Name

Sierra Eye Associates

City

Reno

State/Province

Nevada

ZIP/Postal Code

89502

Country

United States

Facility Name

NJ Retina

City

Edison

State/Province

New Jersey

ZIP/Postal Code

08820

Country

United States

Facility Name

Retina Associates of NJ

City

Teaneck

State/Province

New Jersey

ZIP/Postal Code

07666

Country

United States

Facility Name

Long Is. Vitreoretinal Consult

City

Hauppauge

State/Province

New York

ZIP/Postal Code

11788

Country

United States

Facility Name

Retina Vit Surgeons/Central NY

City

Liverpool

State/Province

New York

ZIP/Postal Code

13088

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

The Retina Consultants

City

Slingerlands

State/Province

New York

ZIP/Postal Code

12159

Country

United States

Facility Name

Western Carolina Retinal Associate PA

City

Asheville

State/Province

North Carolina

ZIP/Postal Code

28803

Country

United States

Facility Name

Char Eye Ear &Throat Assoc

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28210

Country

United States

Facility Name

Graystone Eye

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28602

Country

United States

Facility Name

Carolina Eye Associates

City

Southern Pines

State/Province

North Carolina

ZIP/Postal Code

28387

Country

United States

Facility Name

Cincinnati Eye Institute

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45242

Country

United States

Facility Name

Retina Northwest

City

Portland

State/Province

Oregon

ZIP/Postal Code

97221

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

Charleston Neuroscience Inst

City

Ladson

State/Province

South Carolina

ZIP/Postal Code

29456

Country

United States

Facility Name

Black Hills Eye Institute

City

Rapid City

State/Province

South Dakota

ZIP/Postal Code

57701

Country

United States

Facility Name

Charles Retina Institute

City

Germantown

State/Province

Tennessee

ZIP/Postal Code

38138

Country

United States

Facility Name

Tennessee Retina PC.

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

Facility Name

Texas Retina Associates

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Valley Retina Institute P.A.

City

Harlingen

State/Province

Texas

ZIP/Postal Code

78550

Country

United States

Facility Name

Retina & Vitreous of Texas

City

Houston

State/Province

Texas

ZIP/Postal Code

77025

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

Rocky Mountain Retina

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84107

Country

United States

Facility Name

Spokane Eye Clinical Research

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

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

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

The Retina Centre of Ottawa

City

Ottawa

State/Province

Ontario

ZIP/Postal Code

K2B 7E9

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

Institut De L'Oeil Des Laurentides

City

Boisbriand

State/Province

Quebec

ZIP/Postal Code

J7H 0E8

Country

Canada

Facility Name

Michel Giunta Clinique Medical

City

Sherbrooke

State/Province

Quebec

ZIP/Postal Code

J1G 2V4

Country

Canada

Facility Name

Universitätsklinikum Freiburg, Klinik für Augenheilkunde

City

Freiburg

ZIP/Postal Code

79106

Country

Germany

Facility Name

Universitätsklinik Heidelberg; Augenklinik

City

Heidelberg

ZIP/Postal Code

69120

Country

Germany

Facility Name

Universitätsklinikum Tübingen

City

Tübingen

ZIP/Postal Code

72076

Country

Germany

Facility Name

Budapest Retina Associates Kft.

City

Budapest

ZIP/Postal Code

1133

Country

Hungary

Facility Name

Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika

City

Debrecen

ZIP/Postal Code

4032

Country

Hungary

Facility Name

Ganglion Medial Center

City

Pécs

ZIP/Postal Code

7621

Country

Hungary

Facility Name

Zala Megyei Kórház; SZEMESZET

City

Zalaegerszeg

ZIP/Postal Code

8900

Country

Hungary

Facility Name

Rambam Medical Center; Opthalmology

City

Haifa

ZIP/Postal Code

3109601

Country

Israel

Facility Name

Hadassah MC; Ophtalmology

City

Jerusalem

ZIP/Postal Code

9112001

Country

Israel

Facility Name

Rabin MC; Ophtalmology

City

Petach Tikva

ZIP/Postal Code

4941492

Country

Israel

Facility Name

Kaplan Medical Center; Ophtalmology

City

Rehovot

ZIP/Postal Code

7660101

Country

Israel

Facility Name

Tel Aviv Sourasky MC; Ophtalmology

City

Tel Aviv

ZIP/Postal Code

6423906

Country

Israel

Facility Name

Fondazione G.B. Bietti Per Lo Studio E La Ricerca in Oftalmologia-Presidio Ospedaliero Britannico

City

Roma

State/Province

Lazio

ZIP/Postal Code

00198

Country

Italy

Facility Name

Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica

City

Milano

State/Province

Lombardia

ZIP/Postal Code

20100

Country

Italy

Facility Name

Azienda Ospedaliera di Perugia Ospedale S. Maria Della Misericordia; Clinica Oculistica

City

Perugia

State/Province

Umbria

ZIP/Postal Code

06129

Country

Italy

Facility Name

Chukyo Hospital

City

Aichi

ZIP/Postal Code

457-8510

Country

Japan

Facility Name

Nagoya University Hospital

City

Aichi

ZIP/Postal Code

466-8560

Country

Japan

Facility Name

Nagoya City University Hospital

City

Aichi

ZIP/Postal Code

467-8602

Country

Japan

Facility Name

Aichi Medical University Hospital

City

Aichi

ZIP/Postal Code

480-1195

Country

Japan

Facility Name

Daiyukai Daiichi Hospital

City

Aichi

ZIP/Postal Code

491-8551

Country

Japan

Facility Name

Chiba University Hospital

City

Chiba

ZIP/Postal Code

260-8677

Country

Japan

Facility Name

Toho University Sakura Medical Center

City

Chiba

ZIP/Postal Code

285-8741

Country

Japan

Facility Name

Hayashi Eye Hospital

City

Fukuoka

ZIP/Postal Code

812-0011

Country

Japan

Facility Name

Kurume University Hospital

City

Fukuoka

ZIP/Postal Code

830-0011

Country

Japan

Facility Name

Fukushima Medical University Hospital

City

Fukushima

ZIP/Postal Code

960-1295

Country

Japan

Facility Name

Southern TOHOKU Eye Clinic

City

Fukushima

ZIP/Postal Code

963-8052

Country

Japan

Facility Name

Sapporo City General Hospital

City

Hokkaido

ZIP/Postal Code

060-8604

Country

Japan

Facility Name

Hokkaido University Hospital

City

Hokkaido

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

Asahikawa Medical University Hospital

City

Hokkaido

ZIP/Postal Code

078-8510

Country

Japan

Facility Name

Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)

City

Hyogo

ZIP/Postal Code

660-8550

Country

Japan

Facility Name

Hyogo Medical University Hospital

City

Hyogo

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

Kozawa eye hospital and diabetes center

City

Ibaraki

ZIP/Postal Code

310-0845

Country

Japan

Facility Name

Kagawa University Hospital

City

Kagawa

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

Kagoshima University Hospital

City

Kagoshima

ZIP/Postal Code

890-8520

Country

Japan

Facility Name

Ideta Eye Hospital

City

Kumamoto

ZIP/Postal Code

860-0027

Country

Japan

Facility Name

Kyoto University Hospital

City

Kyoto

ZIP/Postal Code

606-8507

Country

Japan

Facility Name

Mie University Hospital

City

Mie

ZIP/Postal Code

514-8507

Country

Japan

Facility Name

University of Miyazaki Hospital

City

Miyazaki

ZIP/Postal Code

889-1692

Country

Japan

Facility Name

Shinshu University Hospital

City

Nagano

ZIP/Postal Code

390-8621

Country

Japan

Facility Name

Iida Municipal Hospital

City

Nagano

ZIP/Postal Code

395-8502

Country

Japan

Facility Name

Japanese Red Cross Nagasaki Genbaku Hospital

City

Nagasaki

ZIP/Postal Code

852-8511

Country

Japan

Facility Name

Nara Medical University Hospital

City

Nara

ZIP/Postal Code

634-8522

Country

Japan

Facility Name

University of the Ryukyus Hospital

City

Okinawa

ZIP/Postal Code

903-0125

Country

Japan

Facility Name

Kitano Hospital

City

Osaka

ZIP/Postal Code

530-8480

Country

Japan

Facility Name

Osaka Metropolitan University Hospital

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

Kansai Medical University Medical Center

City

Osaka

ZIP/Postal Code

570-8507

Country

Japan

Facility Name

Kansai Medical University Hospital

City

Osaka

ZIP/Postal Code

573-1191

Country

Japan

Facility Name

National Defense Medical College Hospital

City

Saitama

ZIP/Postal Code

359-8513

Country

Japan

Facility Name

Shiga University Of Medical Science Hospital

City

Shiga

ZIP/Postal Code

520-2192

Country

Japan

Facility Name

Tokushima University Hospital

City

Tokushima

ZIP/Postal Code

770-8503

Country

Japan

Facility Name

Nihon University Hospital

City

Tokyo

ZIP/Postal Code

101-8309

Country

Japan

Facility Name

Takeuchi eye clinic

City

Tokyo

ZIP/Postal Code

111-0051

Country

Japan

Facility Name

Tokyo Women's Medical University Hospital

City

Tokyo

ZIP/Postal Code

162-8666

Country

Japan

Facility Name

Kyorin University Hospital

City

Tokyo

ZIP/Postal Code

181-8611

Country

Japan

Facility Name

Tokyo Medical University Hachioji Medical Center

City

Tokyo

ZIP/Postal Code

193-0998

Country

Japan

Facility Name

Yamaguchi University Hospital

City

Yamaguchi

ZIP/Postal Code

755-8505

Country

Japan

Facility Name

Centro Oftalmológico Mira, S.C

City

Del. Cuauhtemoc

State/Province

Mexico CITY (federal District)

ZIP/Postal Code

06760

Country

Mexico

Facility Name

Macula Retina Consultores

City

Mexico, D.F.

ZIP/Postal Code

01120

Country

Mexico

Facility Name

Montemayor & Asociados (Oftalmologos)

City

Monterrey Nuevo LEON

ZIP/Postal Code

64060

Country

Mexico

Facility Name

Het Oogziekenhuis Rotterdam

City

Rotterdam

ZIP/Postal Code

3011 BH

Country

Netherlands

Facility Name

ETZ Elisabeth

City

Tilburg

ZIP/Postal Code

5022 GC

Country

Netherlands

Facility Name

Szpital sw. Lukasza

City

Bielsko-Biala

ZIP/Postal Code

43-309

Country

Poland

Facility Name

Specjalistyczny Ośrodek Okulistyczny Oculomedica

City

Bydgoszcz

ZIP/Postal Code

85-870

Country

Poland

Facility Name

Szpital Specjalistyczny nr 1; Oddzial Okulistyki

City

Bytom

ZIP/Postal Code

41-902

Country

Poland

Facility Name

Dobry Wzrok Sp Z O O

City

Gdańsk

ZIP/Postal Code

80-402

Country

Poland

Facility Name

Gabinet Okulistyczny Prof Edward Wylegala

City

Katowice

ZIP/Postal Code

40-594

Country

Poland

Facility Name

Centrum Medyczne Dietla 19 Sp. Z O.O.

City

Kraków

ZIP/Postal Code

31-070

Country

Poland

Facility Name

SPEKTRUM Osrodek Okulistyki Klinicznej

City

Wroclaw

ZIP/Postal Code

53-334

Country

Poland

Facility Name

Medical Military Academy n.a S.M.Kirov

City

St.Petersburg

State/Province

Sankt Petersburg

ZIP/Postal Code

124044

Country

Russian Federation

Facility Name

Clinics of Eye Diseases, LLC

City

Kazan

State/Province

Tatarstan

ZIP/Postal Code

420066

Country

Russian Federation

Facility Name

FSBI "Scientific Research Institute of Eye Diseases" of Russian Academy of medical Sciences

City

Moscow

ZIP/Postal Code

119435

Country

Russian Federation

Facility Name

Hospital General de Catalunya

City

San Cugat Del Valles

State/Province

Barcelona

ZIP/Postal Code

08195

Country

Spain

Facility Name

Instituto Oftalmologico Gomez Ulla; Servicio de Oftalmologia

City

Santiago de Compostela

State/Province

LA Coruña

ZIP/Postal Code

15706

Country

Spain

Facility Name

Hospital Universitario Puerta de Hierro

City

Majadahonda

State/Province

Madrid

ZIP/Postal Code

28222

Country

Spain

Facility Name

Clinica Universitaria 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

Hospital dos de maig; servicio de oftalmologia

City

Barcelona

ZIP/Postal Code

08025

Country

Spain

Facility Name

Clinica Universitaria de Navarra; Servicio de Oftalmologia

City

Madrid

ZIP/Postal Code

28027

Country

Spain

Facility Name

Clinica Baviera; Servicio Oftalmologia

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Vista Klinik Ophthalmologische Klinik

City

Binningen

ZIP/Postal Code

4102

Country

Switzerland

Facility Name

Stadtspital Triemli Ophthalmologische Klinik

City

Zürich

ZIP/Postal Code

8063

Country

Switzerland

Facility Name

Ankara Baskent University Medical Faculty; Department of Ophthalmology

City

Ankara

ZIP/Postal Code

06490

Country

Turkey

Facility Name

Kocaeli Üniversitesi Tıp Fakültesi; Department of Ophthalmology

City

Kocaeli

ZIP/Postal Code

41380

Country

Turkey

Facility Name

Selcuk University Faculty of Medicine; Department Of Ophthalmology

City

Konya

ZIP/Postal Code

42130

Country

Turkey

Facility Name

Bradford Royal Infirmary

City

Bradford

ZIP/Postal Code

BD9 6RJ

Country

United Kingdom

Facility Name

Bristol Eye Hospital

City

Bristol

ZIP/Postal Code

BS1 2LX

Country

United Kingdom

Facility Name

University Hospital of Wales

City

Cardiff

ZIP/Postal Code

CF14 4XW

Country

United Kingdom

Facility Name

Frimley Park Hospital

City

Frimley

ZIP/Postal Code

GU16 7UJ

Country

United Kingdom

Facility Name

Gloucestershire Royal Hospital

City

Gloucester

ZIP/Postal Code

GL1 3NN

Country

United Kingdom

Facility Name

Hull Royal Infirmary

City

Hull

ZIP/Postal Code

HU3 2JZ

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

Manchester Royal Infirmary

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

Facility Name

Royal Victoria Infirmary

City

Newcastle upon Tyne

ZIP/Postal Code

NE1 4LP

Country

United Kingdom

Facility Name

Southampton General Hospital

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

New Cross Hospital

City

Wolverhampton

ZIP/Postal Code

WV10 0QP

Country

United Kingdom

Facility Name

The York Hospital

City

York

ZIP/Postal Code

YO31 8HE

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

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 (TENAYA)

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