A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON)
Macular Edema, Branch Retinal Vein Occlusion
About this trial
This is an interventional treatment trial for Macular Edema focused on measuring BRVO
Eligibility Criteria
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
Sites / Locations
- Retinal Research Institute, LLC
- Retina Associates Southwest PC
- Retinal Diagnostic Center
- The Retina Partners
- California Eye Specialists Medical group Inc.
- Retina Consultants, San Diego
- Retina Consultants of Southern Colorado PC
- Retina Group of New England
- Florida Eye Associates
- Fort Lauderdale Eye Institute
- Retina Vitreous Assoc of FL
- Southern Vitreoretinal Assoc
- Retina Associates of Florida, LLC
- Southeast Retina Center
- Georgia Retina PC
- Retina Consultants of Hawaii
- University Retina and Macula Associates, PC
- Prairie Retina Center
- Cumberland Valley Retina PC
- Tufts Medical Center; Ophthalmology
- Assoc Retinal Consultants PC
- VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
- Midwest Vision Research Foundation
- Sierra Eye Associates
- Retina Associates of NJ
- Long Is. Vitreoretinal Consult
- Retina Vit Surgeons/Central NY
- Graystone Eye
- Cincinnati Eye Institute
- Black Hills Eye Institute
- Charles Retina Institute
- Tennessee Retina PC
- Retina Res Institute of Texas
- Austin Retina Associates
- Retina & Vitreous of Texas
- Texas Retina Associates
- Retina Consultants of Texas
- Strategic Clinical Research Group, LLC
- Retina Associates of Utah, PLLC
- Fundacion Zambrano
- Centro Oftalmológico Dr. Charles S.A.
- Oftalmos
- Hospital Italiano; Ophtalmology
- Buenos Aires Mácula
- Oftar
- Centro Oftalmólogos Especialistas
- Grupo Laser Vision
- Organizacion Medica de Investigacion
- Strathfield Retina Clinic
- Save Sight Institute
- Sydney Retina Clinic and Day Surgery
- Centre For Eye Research Australia
- Retina Specialists Victoria
- The Lions Eye Institute
- LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
- Hospital das Clinicas - UFRGS
- Botelho Hospital da Visao
- Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
- Hosp de Olhos de Sorocaba
- Beijing Hospital of Ministry of Health
- The Second Hospital of Jilin University
- West China Hospital, Sichuan University
- Zhongshan Ophthalmic Center, Sun Yat-sen University
- The 2nd Affiliated Hospital of Harbin Medical University
- The Affiliated Eye Hospital of Nanjing Medical University
- Shanghai Tenth People's Hospital
- Shanghai First People's Hospital
- He Eye Specialist Shenyang Hospital
- Tianjin Eye Hospital
- Tianjin Medical University Eye Hospital
- Eye Hospital, Wenzhou Medical University
- Renmin Hospital of Wuhan University
- Henan Provincial Eye Hosptial
- Faculty Hospital Ostrava; Ophthalmology clinic
- Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
- AXON Clinical
- Nemocnice Sokolov
- Chi De Creteil; Ophtalmologie
- Hopital Lariboisiere; Ophtalmologie
- Universitätsklinikum Freiburg, Klinik für Augenheilkunde
- Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
- Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
- Queen Mary Hospital; Department of Ophthalmology
- Hong Kong Eye Hospital; CUHK Eye Centre
- Budapest Retina Associates Kft.
- Debreceni Egyetem Klinikai Kozpont; Szemeszeti Klinika
- Ganglion Medial Center
- Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
- Rambam Medical Center; Opthalmology
- Hadassah MC; Ophtalmology
- Rabin MC; Ophtalmology
- Kaplan Medical Center; Ophtalmology
- Tel Aviv Sourasky MC; Ophtalmology
- Fondazione Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
- Fondazione Irccs Ca' Granda Ospedale Maggiore Policlinico-Clinica Regina Elena;U.O.C Oculistica
- Azienda Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
- Sugita Eye Hospital
- Nagoya University Hospital
- Nagoya City University Hospital
- Aichi Medical University Hospital
- Toho University Sakura Medical Center
- Hayashi Eye Hospital
- Southern TOHOKU Eye Clinic
- Asahikawa Medical University Hospital
- Hyogo Prefectural Amagasaki General Medical Center (Hyogo AGMC)
- Hyogo Medical University Hospital
- Kozawa eye hospital and diabetes center
- Kyoto University Hospital
- Tokushima University Hospital
- Nihon University Hospital
- Tokyo Medical University Hachioji Medical Center
- Pusan National University Hospital
- Yeungnam University Medical Center
- Seoul National University Bundang Hospital
- Kyung Hee University Hospital
- Asan Medical Center
- Samsung Medical Center
- Specjalistyczny O?rodek Okulistyczny Oculomedica
- Szpital Specjalistyczny nr 1; Oddzial Okulistyki
- Dobry Wzrok Sp Z O O
- Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
- Gabinet Okulistyczny Prof Edward Wylegala
- Centrum Medyczne Dietla 19 Sp. Z O.O.
- Centrum Medyczne Pulawska SP. z o.o.
- Lens Clinic
- Caminomed
- Centrum Zdrowia MDM
- Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
- Espaco Medico Coimbra
- Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia
- Clinic Optimed
- Clinics of Eye Diseases, LLC
- ?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
- Singapore Eye Research Institute
- Tan Tock Seng Hospital; Ophthalmology Department
- Clinica Universitaria de Navarra; Servicio de Oftalmologia
- Oftalvist Valencia
- Hospital dos de maig; servicio de oftalmologia
- Clinica Baviera; Servicio Oftalmologia
- Hospital Universitario Rio Hortega; Servicio de Oftalmologia
- Changhua Christian Hospital; Department of Ophthalmology
- Taipei Veterans General Hospital; Ophthalmology
- Chang Gung Medical Foundation - Linkou; Ophthalmology
- National Taiwan University Hospital; Ophthalmology
- Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
- Bristol Eye Hospital;Retinal Treatment and Research Unit
- University Hospital of Wales
- Gloucestershire Hospitals NHS Foundation Trust
- St James University Hospital
- Central Middlesex Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
Arm B: Aflibercept 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).
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).