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
2 other identifiers
interventional
553
21 countries
144
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2021
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 3, 2021
CompletedFirst Posted
Study publicly available on registry
February 5, 2021
CompletedStudy Start
First participant enrolled
March 2, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 6, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 12, 2023
CompletedResults Posted
Study results publicly available
January 18, 2024
CompletedAugust 6, 2024
July 1, 2024
1.3 years
February 3, 2021
November 22, 2023
July 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (47)
Part 1: Change From Baseline in BCVA in the Study Eye at Specified Timepoints Through Week 24
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
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
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
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
Baseline, Weeks 4, 8, 12, 16, 20, and 24
- +42 more secondary outcomes
Study Arms (2)
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
EXPERIMENTALIn 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).
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
ACTIVE COMPARATORIn 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).
Interventions
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
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).
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- 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)
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Hoffmann-La Rochelead
- Chugai Pharmaceuticalcollaborator
Study Sites (150)
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
Retina Associates Southwest PC
Tucson, Arizona, 85704, United States
Retinal Diagnostic Center
Campbell, California, 95008, United States
The Retina Partners
Encino, California, 91436, United States
California Eye Specialists Medical group Inc.
Pasadena, California, 91107, United States
Retina Consultants, San Diego
Poway, California, 92064, United States
Retina Consultants of Southern Colorado PC
Colorado Springs, Colorado, 80909, United States
Retina Group of New England
Waterford, Connecticut, 06385, United States
Florida Eye Associates
Melbourne, Florida, 32901, United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324, United States
Retina Vitreous Assoc of FL
St. Petersburg, Florida, 33711, United States
Southern Vitreoretinal Assoc
Tallahassee, Florida, 32308, United States
Retina Associates of Florida, LLC
Tampa, Florida, 33609, United States
Southeast Retina Center
Augusta, Georgia, 30909, United States
Georgia Retina PC
Marietta, Georgia, 30060-1137, United States
Retina Consultants of Hawaii
‘Aiea, Hawaii, 96701, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Prairie Retina Center
Springfield, Illinois, 62704, United States
Cumberland Valley Retina PC
Hagerstown, Maryland, 21740, United States
Tufts Medical Center; Ophthalmology
Boston, Massachusetts, 02111, United States
Assoc Retinal Consultants PC
Royal Oak, Michigan, 48073, United States
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
Edina, Minnesota, 55435, United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017, United States
Sierra Eye Associates
Reno, Nevada, 89502, United States
Retina Associates of NJ
Teaneck, New Jersey, 07666, United States
Long Is. Vitreoretinal Consult
Hauppauge, New York, 11788, United States
Retina Vit Surgeons/Central NY
Liverpool, New York, 13088, United States
Graystone Eye
Hickory, North Carolina, 28602, United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242, United States
Black Hills Eye Institute
Rapid City, South Dakota, 57701, United States
Charles Retina Institute
Germantown, Tennessee, 38138, United States
Tennessee Retina PC
Nashville, Tennessee, 37203, United States
Retina Res Institute of Texas
Abilene, Texas, 79606, United States
Austin Retina Associates
Austin, Texas, 78705-1169, United States
Retina & Vitreous of Texas
Bellaire, Texas, 77401-3510, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384-4167, United States
Strategic Clinical Research Group, LLC
Willow Park, Texas, 76087, United States
Retina Associates of Utah, PLLC
Salt Lake City, Utah, 84107, United States
Fundacion Zambrano
CABA, C1017AAO, Argentina
Centro Oftalmológico Dr. Charles S.A.
Capital Federal, C1015ABO, Argentina
Oftalmos
Capital Federal, C1120AAN, Argentina
Hospital Italiano; Ophtalmology
Capital Federal, C1199ABC, Argentina
Buenos Aires Mácula
Ciudad Autonoma Buenos Aires, C1061AAE, Argentina
Oftar
Mendoza, M5500GGK, Argentina
Centro Oftalmólogos Especialistas
Rosario, S2000ANJ, Argentina
Grupo Laser Vision
Rosario, S2000DLA, Argentina
Organizacion Medica de Investigacion
San Nicolás, C1015ABO, Argentina
Strathfield Retina Clinic
Strathfield, New South Wales, 2135, Australia
Save Sight Institute
Sydney, New South Wales, 2000, Australia
Sydney Retina Clinic and Day Surgery
Sydney, New South Wales, 2000, Australia
Centre For Eye Research Australia
East Melbourne, Victoria, 3002, Australia
Retina Specialists Victoria
Rowville, Victoria, 3178, Australia
The Lions Eye Institute
Nedlands, Western Australia, 6009, Australia
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
Graz, 8036, Austria
Hospital das Clinicas - UFRGS
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Botelho Hospital da Visao
Blumenau, Santa Catarina, 89052-504, Brazil
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
São Paulo, São Paulo, 04023-062, Brazil
Hosp de Olhos de Sorocaba
Sorocaba, São Paulo, 18031-060, Brazil
Beijing Hospital of Ministry of Health
Beijing, 100730, China
The Second Hospital of Jilin University
Changchun, 130041, China
West China Hospital, Sichuan University
Chengdu, 610041, China
Zhongshan Ophthalmic Center, Sun Yat-sen University
Guangzhou, 510060, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, 150001, China
The Affiliated Eye Hospital of Nanjing Medical University
Nanjing, 210029, China
Shanghai Tenth People's Hospital
Shanghai, 200072, China
Shanghai First People's Hospital
Shanghai, 200080, China
He Eye Specialist Shenyang Hospital
Shenyang, 110034, China
Tianjin Eye Hospital
Tianjin, 300050, China
Tianjin Medical University Eye Hospital
Tianjin, 300070, China
Eye Hospital, Wenzhou Medical University
Wenzhou, 325027, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Henan Provincial Eye Hosptial
Zhengzhou, China
Faculty Hospital Ostrava; Ophthalmology clinic
Ostrava, 708 52, Czechia
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
Prague, 100 34, Czechia
AXON Clinical
Prague, Czechia
Nemocnice Sokolov
Sokolov, 356 01, Czechia
Chi De Creteil; Ophtalmologie
Créteil, 94010, France
Hopital Lariboisiere; Ophtalmologie
Paris, 75010, France
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
Freiburg im Breisgau, 79106, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
Göttingen, 37075, Germany
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
Ludwigshafen, 67063, Germany
Queen Mary Hospital; Department of Ophthalmology
Hong Kong, Hong Kong
Hong Kong Eye Hospital; CUHK Eye Centre
Mong Kok, Hong Kong
Budapest Retina Associates Kft.
Budapest, 1133, Hungary
Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
Debrecen, 4032, Hungary
Ganglion Medial Center
Pécs, 7621, Hungary
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
Szeged, 6720, Hungary
Rambam Medical Center; Opthalmology
Haifa, 3109601, Israel
Hadassah MC; Ophtalmology
Jerusalem, 9112001, Israel
Rabin MC; Ophtalmology
Petah Tikva, 4941492, Israel
Kaplan Medical Center; Ophtalmology
Rehovot, 7660101, Israel
Tel Aviv Sourasky MC; Ophtalmology
Tel Aviv, 6423906, Israel
Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
Rome, Lazio, 00133, Italy
Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
Milan, Lombardy, 20100, Italy
Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
Florence, Tuscany, 50134, Italy
Sugita Eye Hospital
Aichi, 460-0008, Japan
Nagoya University Hospital
Aichi, 466-8560, Japan
Nagoya City University Hospital
Aichi, 467-8602, Japan
Aichi Medical University Hospital
Aichi, 480-1195, Japan
Toho University Sakura Medical Center
Chiba, 285-8741, Japan
Hayashi Eye Hospital
Fukuoka, 812-0011, Japan
Southern TOHOKU Eye Clinic
Fukushima, 963-8052, Japan
Asahikawa Medical University Hospital
Hokkaido, 078-8510, Japan
Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
Hyōgo, 660-8550, Japan
Hyogo Medical University Hospital
Hyōgo, 663-8501, Japan
Kozawa eye hospital and diabetes center
Ibaraki, 310-0845, Japan
Kyoto University Hospital
Kyoto, 606-8507, Japan
Tokushima University Hospital
Tokushima, 770-8503, Japan
Nihon University Hospital
Tokyo, 101-8309, Japan
Tokyo Medical University Hachioji Medical Center
Tokyo, 193-0998, Japan
Specjalistyczny O?rodek Okulistyczny Oculomedica
Bydgoszcz, 85-870, Poland
Szpital Specjalistyczny nr 1; Oddzial Okulistyki
Bytom, 41-902, Poland
Dobry Wzrok Sp Z O O
Gda?sk, 80-402, Poland
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
Gliwice, 44-100, Poland
Gabinet Okulistyczny Prof Edward Wylegala
Katowice, 40-594, Poland
Centrum Medyczne Dietla 19 Sp. Z O.O.
Krakow, 31-070, Poland
Centrum Medyczne Pulawska SP. z o.o.
Piaseczno, 05-500, Poland
Lens Clinic
Rybnik, 44-203, Poland
Caminomed
Tarnowskie Góry, 42-600, Poland
Centrum Zdrowia MDM
Warsaw, 00-189, Poland
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
Coimbra, 3000-075, Portugal
Espaco Medico Coimbra
Coimbra, 3030-163, Portugal
Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia
Porto, 4099-001, Portugal
Clinic Optimed
Ufa, Bashkortostan Republic, 450059, Russia
Clinics of Eye Diseases, LLC
Kazan', Tatarstan Republic, 420066, Russia
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
Irkutsk, 664033, Russia
Singapore Eye Research Institute
Singapore, 168751, Singapore
Tan Tock Seng Hospital; Ophthalmology Department
Singapore, 308433, Singapore
Pusan National University Hospital
Busan, 602-739, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 463-707, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Asan Medical Center
Seoul, 05505, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Clinica Universitaria de Navarra; Servicio de Oftalmologia
Pamplona, Navarre, 31008, Spain
Oftalvist Valencia
Burjassot, Valencia, 46100, Spain
Hospital dos de maig; servicio de oftalmologia
Barcelona, 08025, Spain
Clinica Baviera; Servicio Oftalmologia
Madrid, 28046, Spain
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
Valladolid, 47012, Spain
Changhua Christian Hospital; Department of Ophthalmology
Changhua, 500, Taiwan
Taipei Veterans General Hospital; Ophthalmology
Taipei, 11217, Taiwan
Chang Gung Medical Foundation - Linkou; Ophthalmology
Taoyuan District, 333, Taiwan
National Taiwan University Hospital; Ophthalmology
Zhongzheng Dist., 10002, Taiwan
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
Belfast, BT12 6BA, United Kingdom
Bristol Eye Hospital;Retinal Treatment and Research Unit
Bristol, BS1 2LX, United Kingdom
University Hospital of Wales
Cardiff, CF14 4XW, United Kingdom
Gloucestershire Hospitals NHS Foundation Trust
Gloucestershire, GL1 3NN, United Kingdom
St James University Hospital
Leeds, LS9 7TF, United Kingdom
Central Middlesex Hospital
London, NW10 7NS, United Kingdom
Related Publications (1)
Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.
PMID: 36912792DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2021
First Posted
February 5, 2021
Study Start
March 2, 2021
Primary Completion
July 6, 2022
Study Completion
June 12, 2023
Last Updated
August 6, 2024
Results First Posted
January 18, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will share
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing