A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON)

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion

This is a Phase III, multicenter, randomized, double-masked, active comparator-controlled, parallel-group study evaluating the efficacy, safety, and pharmacokinetics of faricimab administered by intravitreal (IVT) injection at 4-week intervals until Week 24, followed by a double-masked period of study without active control to evaluate faricimab administered according to a personalized treatment interval (PTI) dosing regimen in participants with macular edema due to branch retinal vein occlusion (BRVO).

Study Overview

• Status: Completed
• Conditions: Macular Edema; Branch Retinal Vein Occlusion
• Intervention / Treatment: Drug: Faricimab; Procedure: Sham Procedure; Drug: Aflibercept

• Study Type: Interventional
• Enrollment (Actual): 553
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Caba, Argentina, C1017AAO
    • Fundacion Zambrano
  • Capital Federal, Argentina, C1015ABO
    • Centro Oftalmológico Dr. Charles S.A.
  • Capital Federal, Argentina, C1120AAN
    • Oftalmos
  • Capital Federal, Argentina, C1199ABC
    • Hospital Italiano; Ophtalmology
  • Ciudad Autonoma Buenos Aires, Argentina, C1061AAE
    • Buenos Aires Mácula
  • Mendoza, Argentina, M5500GGK
    • Oftar
  • Rosario, Argentina, S2000DLA
    • Grupo Laser Vision
  • Rosario, Argentina, S2000ANJ
    • Centro Oftalmólogos Especialistas
  • San Nicolás, Argentina, C1015ABO
    • Organizacion Medica de Investigacion
• Australia
  • New South Wales
    • Strathfield, New South Wales, Australia, 2135
      • Strathfield Retina Clinic
    • Sydney, New South Wales, Australia, 2000
      • Save Sight Institute
    • Sydney, New South Wales, Australia, 2000
      • Sydney Retina Clinic and Day Surgery
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Centre for Eye Research Australia
    • Rowville, Victoria, Australia, 3178
      • Retina Specialists Victoria
  • Western Australia
    • Nedlands, Western Australia, Australia, 6009
      • The Lions Eye Institute
• Austria
  • Graz, Austria, 8036
    • LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
• Brazil
  • RS
    • Porto Alegre, RS, Brazil, 90035-903
      • Hospital das Clinicas - UFRGS
  • SC
    • Blumenau, SC, Brazil, 89052-504
      • Botelho Hospital da Visao
  • SP
    • Sao Paulo, SP, Brazil, 04023-062
      • Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
    • Sorocaba, SP, Brazil, 18031-060
      • Hosp de Olhos de Sorocaba
• China
  • Beijing, China, 100730
    • Beijing Hospital of Ministry of Health
  • Changchun, China, 130041
    • The Second Hospital of Jilin University
  • Chengdu, China, 610041
    • West China Hospital, Sichuan University
  • Guangzhou City, China, 510060
    • Zhongshan Ophthalmic Center, Sun Yat-sen University
  • Harbin, China, 150001
    • The 2nd Affiliated Hospital Of Harbin Medical University
  • Nanjing City, China, 210029
    • The Affiliated Eye Hospital of Nanjing Medical University
  • Shanghai, China, 200080
    • Shanghai First People's Hospital
  • Shanghai, China, 200072
    • Shanghai Tenth People's Hospital
  • Shenyang City, China, 110034
    • He Eye Specialist Shenyang Hospital
  • Tianjin City, China, 300050
    • TianJin eye hospital
  • Tianjin City, China, 300070
    • Tianjin Medical University Eye Hospital
  • Wenzhou City, China, 325027
    • Eye Hospital, Wenzhou Medical University
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Zhengzhou, China
    • Henan Provincial Eye Hosptial
• Czechia
  • Ostrava, Czechia, 708 52
    • Faculty Hospital Ostrava; Ophthalmology clinic
  • Prague, Czechia, 100 34
    • Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
  • Prague, Czechia
    • AXON Clinical
  • Sokolov, Czechia, 356 01
    • Nemocnice Sokolov
• France
  • Creteil, France, 94010
    • Chi De Creteil; Ophtalmologie
  • Paris, France, 75010
    • Hopital Lariboisiere; Ophtalmologie
• Germany
  • Freiburg, Germany, 79106
    • Universitätsklinikum Freiburg, Klinik für Augenheilkunde
  • Göttingen, Germany, 37075
    • Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
  • Ludwigshafen, Germany, 67063
    • Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
• Hong Kong
  • Hong Kong, Hong Kong
    • Queen Mary Hospital; Department of Ophthalmology
  • Mongkok, Hong Kong
    • Hong Kong Eye Hospital; CUHK Eye Centre
• Hungary
  • Budapest, Hungary, 1133
    • Budapest Retina Associates Kft.
  • Debrecen, Hungary, 4032
    • Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
  • Pécs, Hungary, 7621
    • Ganglion Medial Center
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
• Israel
  • Haifa, Israel, 3109601
    • Rambam Medical Center; Opthalmology
  • Jerusalem, Israel, 9112001
    • Hadassah MC; Ophtalmology
  • Petach Tikva, Israel, 4941492
    • Rabin MC; Ophtalmology
  • Rehovot, Israel, 7660101
    • Kaplan Medical Center; Ophtalmology
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky MC; Ophtalmology
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
  • Lombardia
    • Milano, Lombardia, Italy, 20100
      • Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
• Japan
  • Aichi, Japan, 480-1195
    • Aichi Medical University Hospital
  • Aichi, Japan, 460-0008
    • Sugita Eye Hospital
  • Aichi, Japan, 466-8560
    • Nagoya University Hospital
  • Aichi, Japan, 467-8602
    • Nagoya City University Hospital
  • Chiba, Japan, 285-8741
    • Toho University Sakura Medical Center
  • Fukuoka, Japan, 812-0011
    • Hayashi Eye Hospital
  • Fukushima, Japan, 963-8052
    • Southern Tohoku Eye Clinic
  • Hokkaido, Japan, 078-8510
    • Asahikawa Medical University Hospital
  • Hyogo, Japan, 663-8501
    • Hyogo Medical University Hospital
  • Hyogo, Japan, 660-8550
    • Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
  • Ibaraki, Japan, 310-0845
    • Kozawa Eye Hospital and Diabetes Center
  • Kyoto, Japan, 606-8507
    • Kyoto University Hospital
  • Tokushima, Japan, 770-8503
    • Tokushima University Hospital
  • Tokyo, Japan, 101-8309
    • Nihon University Hospital
  • Tokyo, Japan, 193-0998
    • Tokyo Medical University Hachioji Medical Center
• Korea, Republic of
  • Busan, Korea, Republic of, 602-739
    • Pusan National University Hospital
  • Daegu, Korea, Republic of, 42415
    • Yeungnam University Medical Center
  • Seongnam-si, Korea, Republic of, 463-707
    • Seoul National University Bundang Hospital
  • Seoul, Korea, Republic of, 05505
    • Asan Medical Center
  • Seoul, Korea, Republic of, 02447
    • Kyung Hee University Hospital
  • Seoul, Korea, Republic of, 06351
    • Samsung Medical Center
• Poland
  • Bydgoszcz, Poland, 85-870
    • Specjalistyczny O?rodek Okulistyczny Oculomedica
  • Bytom, Poland, 41-902
    • Szpital Specjalistyczny nr 1; Oddzial Okulistyki
  • Gda?sk, Poland, 80-402
    • Dobry Wzrok Sp Z O O
  • Gliwice, Poland, 44-100
    • Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
  • Katowice, Poland, 40-594
    • Gabinet Okulistyczny Prof Edward Wylegala
  • Kraków, Poland, 31-070
    • Centrum Medyczne Dietla 19 Sp. z o.o.
  • Piaseczno, Poland, 05-500
    • Centrum Medyczne Pulawska SP. z o.o.
  • Rybnik, Poland, 44-203
    • Lens Clinic
  • Tarnowskie Góry, Poland, 42-600
    • Caminomed
  • Warszawa, Poland, 00-635
    • Centrum Zdrowia MDM
• Portugal
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
  • Coimbra, Portugal, 3030-163
    • Espaco Medico Coimbra
  • Porto, Portugal, 4099-001
    • Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia
• Russian Federation
  • Irkutsk, Russian Federation, 664033
    • ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
  • Baskortostan
    • UFA, Baskortostan, Russian Federation, 450059
      • Clinic Optimed
  • Tatarstan
    • Kazan, Tatarstan, Russian Federation, 420066
      • Clinics of Eye Diseases, LLC
• Singapore
  • Singapore, Singapore, 168751
    • Singapore Eye Research Institute
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital; Ophthalmology Department
• Spain
  • Barcelona, Spain, 08025
    • Hospital dos de maig; servicio de oftalmologia
  • Madrid, Spain, 28046
    • Clinica Baviera; Servicio Oftalmologia
  • Valladolid, Spain, 47012
    • Hospital Universitario Rio Hortega; Servicio de Oftalmologia
  • Navarra
    • Pamplona, Navarra, Spain, 31008
      • Clinica Universitaria de Navarra; Servicio de Oftalmologia
  • Valencia
    • Burjassot, Valencia, Spain, 46100
      • Oftalvist Valencia
• Taiwan
  • Changhua, Taiwan, 500
    • Changhua Christian Hospital; Department of Ophthalmology
  • Taipei, Taiwan, 11217
    • Taipei Veterans General Hospital; Ophthalmology
  • Taoyuan, Taiwan, 333
    • Chang Gung Medical Foundation - Linkou; Ophthalmology
  • Zhongzheng Dist., Taiwan, 10002
    • National Taiwan University Hospital; Ophthalmology
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
  • Bristol, United Kingdom, BS1 2LX
    • Bristol Eye Hospital;Retinal Treatment and Research Unit
  • Cardiff, United Kingdom, CF14 4XW
    • University Hospital of Wales
  • Gloucestershire, United Kingdom, GL1 3NN
    • Gloucestershire Hospitals NHS Foundation Trust
  • Leeds, United Kingdom, LS9 7TF
    • St James University Hospital
  • London, United Kingdom, NW10 7NS
    • Central Middlesex Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Research Institute, LLC
    • Tucson, Arizona, United States, 85704
      • Retina Associates Southwest PC
  • California
    • Campbell, California, United States, 95008
      • Retinal Diagnostic Center
    • Encino, California, United States, 91436
      • The Retina Partners
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical group Inc.
    • Poway, California, United States, 92064
      • Retina Consultants, San Diego
  • Colorado
    • Colorado Springs, Colorado, United States, 80909
      • Retina Consultants of Southern Colorado PC
  • Connecticut
    • Waterford, Connecticut, United States, 06385
      • Retina Group of New England
  • Florida
    • Melbourne, Florida, United States, 32901
      • Florida Eye Associates
    • Plantation, Florida, United States, 33324
      • Fort Lauderdale Eye Institute
    • Saint Petersburg, Florida, United States, 33711
      • Retina Vitreous Assoc of FL
    • Tallahassee, Florida, United States, 32308
      • Southern Vitreoretinal Assoc
    • Tampa, Florida, United States, 33609
      • Retina Associates of Florida, LLC
  • Georgia
    • Augusta, Georgia, United States, 30909
      • Southeast Retina Center
    • Marietta, Georgia, United States, 30060-1137
      • Georgia Retina PC
  • Hawaii
    • 'Aiea, Hawaii, United States, 96701
      • Retina Consultants of Hawaii
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates, PC
    • Springfield, Illinois, United States, 62704
      • Prairie Retina Center
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina PC
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center; Ophthalmology
  • Michigan
    • Royal Oak, Michigan, United States, 48073
      • Assoc Retinal Consultants PC
  • Minnesota
    • Edina, Minnesota, United States, 55435
      • VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
  • Missouri
    • Chesterfield, Missouri, United States, 63017
      • Midwest Vision Research Foundation
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Retina Associates of NJ
  • New York
    • Hauppauge, New York, United States, 11788
      • Long Is. Vitreoretinal Consult
    • Liverpool, New York, United States, 13088
      • Retina Vit Surgeons/Central NY
  • North Carolina
    • Hickory, North Carolina, United States, 28602
      • Graystone Eye
  • Ohio
    • Cincinnati, Ohio, United States, 45242
      • Cincinnati Eye Institute
  • South Dakota
    • Rapid City, South Dakota, United States, 57701
      • Black Hills Eye Institute
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute
    • Nashville, Tennessee, United States, 37203
      • Tennessee Retina PC
  • Texas
    • Abilene, Texas, United States, 79606
      • Retina Res Institute of Texas
    • Austin, Texas, United States, 78705-1169
      • Austin Retina Associates
    • Bellaire, Texas, United States, 77401-3510
      • Retina & Vitreous of Texas
    • Dallas, Texas, United States, 75231
      • Texas Retina Associates
    • The Woodlands, Texas, United States, 77384-4167
      • Retina Consultants of Texas
    • Willow Park, Texas, United States, 76087
      • Strategic Clinical Research Group, LLC
  • Utah
    • Salt Lake City, Utah, United States, 84107
      • Retina Associates of Utah, PLLC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Foveal center-involved macular edema due to branch retinal vein occlusion (BRVO), diagnosed no longer than 4 months prior to the screening visit
• Best-corrected visual acuity (BCVA) of 73 to 19 letters, inclusive (20/40 to 20/400 approximate Snellen equivalent) on Day 1
• Sufficiently clear ocular media and adequate pupillary dilatation to allow acquisition of good quality retinal images to confirm diagnosis
• For women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs during the treatment period and for 3 months after the final dose of study treatment

Exclusion Criteria:

• Any major illness or major surgical procedure within 1 month before screening
• Uncontrolled blood pressure
• Stroke (cerebral vascular accident) or myocardial infarction within 6 months prior to Day 1
• Pregnant or breastfeeding, or intending to become pregnant during the study

Ocular Exclusion Criteria for Study Eye:

• History of previous episodes of macular edema due to RVO or persistent macular edema due to RVO diagnosed more than 4 months before screening
• Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than macular edema due to RVO in the study eye (e.g., ischemic maculopathy, Irvine-Gass syndrome, foveal atrophy, foveal fibrosis, pigment abnormalities, dense subfoveal hard exudates, or other non-retinal conditions)
• Macular laser (focal/grid) in the study eye at any time prior to Day 1
• Panretinal photocoagulation in the study eye within 3 months prior to Day 1 or anticipated within 3 months of study start on Day 1
• Any prior or current treatment for macular edema; macular neovascularization, including diabetic macular edema (DME) and neovascular age-related macular degeneration (nAMD); and vitreomacular-interface abnormalities, including, but not restricted to, IVT treatment with anti-VEGF, steroids, tissue plasminogen activator, ocriplasmin, C3F8, air or periocular injection
• Any prior intervention with verteporfin photodynamic therapy, diode laser, transpupillary thermotherapy, or vitreo-retinal surgery including sheatotomy
• Any prior steroid implant use including dexamethasone intravitreal implant (Ozurdex) and fluocinolone acetonide intravitreal implant (Iluvien)

Ocular Exclusion Criteria for Both Eyes:

• Prior IVT administration of faricimab in either eye
• History of idiopathic or autoimmune-associated uveitis in either eye
• Active periocular, ocular or intraocular inflammation or infection (including suspected) in either eye on Day 1

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2); In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm A will receive faricimab 6 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	Drug: Faricimab; Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.; Other Names: RO6867461; RG7716; VABYSMO®; faricimab-svoa; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal (IVT) 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.
Active Comparator: Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2); In Part 1 (Day 1 through Week 24), participants randomly assigned to Arm B will receive aflibercept 2 milligrams (mg) by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections). In Part 2 (from Week 24 to Week 72), participants will receive faricimab 6 mg by IVT injection according to a personalized treatment interval (PTI) dosing regimen. To preserve masking for Part 2, a sham procedure will be administered during study visits at which no faricimab treatment is administered (according to the PTI dosing regimen).	Drug: Faricimab; Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.; Other Names: RO6867461; RG7716; VABYSMO®; faricimab-svoa; Procedure: Sham Procedure; The sham is a procedure that mimics an intravitreal (IVT) 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.; Drug: Aflibercept; Aflibercept 2 mg will be administered by IVT injection once every 4 weeks (Q4W) from Day 1 through Week 20 (a total of 6 injections).; Other Names: Eylea

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part 1: Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 24	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 included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.	From Baseline through Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma Concentration of Faricimab Over Time		Predose at Day 1, Weeks 4, 24, 28, 52, and 72
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68		Week 68
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24	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 included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline BCVA (continuous), and randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline and Week 24
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 24	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 weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by baseline BCVA (>38 and ≤38 letters) and region (U.S. and Canada, Asia, and rest of the world). All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 24	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. The Mixed Model of Repeated Measures (MMRM) analysis included the categorical covariates of treatment arm, visit, visit-by-treatment arm interaction, baseline CST (continuous), and randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)] as fixed effects. An unstructured covariance structure was used. Missing data were implicitly imputed by MMRM model assuming missing at random. Treatment policy strategy (i.e., all observed values used) was applied to all intercurrent events (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 24	Absence of diabetic macular edema was defined as achieving a central subfield thickness of <325 microns in the study eye. Central subfield thickness was defined as the distance between the internal limiting membrane (ILM) and Bruch's membrane (BM) as assessed by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24	Intraretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24	Subretinal fluid was measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24	Intraretinal fluid and subretinal fluid were measured in the study eye using optical coherence tomography (OCT) in the central subfield (center 1 mm) by a central reading center. The weighted percentage of participants was estimated based on the Cochran-Mantel Haenszel (CMH) weights stratified by randomization stratification factors [baseline BCVA (≥55 and ≤54 letters), and region (U.S. and Canada, Asia, and rest of the world)]. All observed values were used regardless of the occurrence of an intercurrent event (discontinuation of treatment due to AEs or lack of efficacy, use of prohibited therapy). Missing assessments were imputed by last observation carried forward. 95% CI is a rounding of 95.03% CI.	Baseline, Weeks 4, 8, 12, 16, 20, and 24
Part 1: Change From Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24	The NEI VFQ-25 captures a patient's perception of vision-related functioning and vision-related quality of life. The core measure includes 25 items that comprise 11 vision-related subscales and 1 item on general health. The composite score ranges from 0 to 100, with higher scores indicating better vision-related functioning. For the ANCOVA analysis, the model uses the non-missing change from baseline in BCVA at Weeks 24 as the response variables adjusted for the treatment group, baseline NEI VFQ-25 Composite Score (continuous), baseline BCVA score (≥55 and ≤54 letters) and region (U.S. and Canada, Asia, and the rest of the world). Observed NEI VFQ-25 assessments were used regardless of the occurrence of intercurrent events. Missing data were not imputed. 95% CI is a rounding of 95.03% CI.	Baseline and Week 24
Parts 1 and 2: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Baseline in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters in BCVA (20/20 Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters in BCVA (20/40 or Better Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants With ≤38 Letters in BCVA (20/200 or Worse Snellen Equivalent) in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Change From Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72		Baseline and Weeks 24, 48, and 72
Parts 1 and 2: Change From Baseline in Central Subfield Thickness in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants With Absence of Macular Edema in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants With Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Parts 1 and 2: Percentage of Participants With Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 72		Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Change From Week 24 in BCVA in the Study Eye at Specified Timepoints Through Week 72		Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72		Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72		Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72		Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA From Week 24 in the Study Eye at Specified Timepoints Through Week 72		Weeks 24, 28, 32, 36, 40, 44, 48, 52, 56, 60, 64, 68, and 72
Part 2: Number of Study Drug Injections Received in the Study Eye From Week 24 Through Week 72		From Week 24 to Week 72
Incidence and Severity of Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale		From Baseline until end of study (up to 72 weeks)
Incidence and Severity of Non-Ocular Adverse Events, With Severity Determined According to Adverse Event Severity Grading Scale		From Baseline until end of study (up to 72 weeks)
Number of Participants With Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study		Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: Chugai Pharmaceutical
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2021
• Primary Completion (Actual): July 6, 2022
• Study Completion (Actual): June 12, 2023

Study Registration Dates

• First Submitted: February 3, 2021
• First Submitted That Met QC Criteria: February 3, 2021
• First Posted (Actual): February 5, 2021

Study Record Updates

• Last Update Posted (Estimated): January 18, 2024
• Last Update Submitted That Met QC Criteria: December 20, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: BRVO
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Retinal Degeneration; Retinal Diseases; Embolism and Thrombosis; Venous Thrombosis; Thrombosis; Macular Degeneration; Macular Edema; Retinal Vein Occlusion; Edema; Physiological Effects of Drugs; Antineoplastic Agents; Angiogenesis Inhibitors; Angiogenesis Modulating Agents; Growth Substances; Growth Inhibitors; Aflibercept; Faricimab
• Other Study ID Numbers: GR41984; 2020-000440-63 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

IPD Plan Description

For eligible studies, 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/innovation/process/clinical-trials/data-sharing/).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No