Back to resultsA Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion (BALATON)
Primary Purpose
Macular Edema, Branch Retinal Vein Occlusion
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Faricimab
Aflibercept
Sham Procedure
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
Arm Description
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).
Outcomes
Primary Outcome Measures
Part 1: Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24
Secondary Outcome Measures
Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Part 1: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Part 1: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24
Part 1: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 24
Part 1: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Part 1: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Part 1: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
Parts 1 and 2: Change from Baseline in BCVA at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Parts 1 and 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Parts 1 and 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants with Absence of Subretinal Fluid at Specified Timepoints Through Week 72
Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid at Specified Timepoints Through Week 72
Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72
Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale
Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale
Plasma Concentration of Faricimab Over Time
Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study
Full Information
NCT ID
NCT04740905
First Posted
February 3, 2021
Last Updated
July 10, 2023
Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
1. Study Identification
Unique Protocol Identification Number
NCT04740905
Brief Title
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
Acronym
BALATON
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Completed
Study Start Date
March 2, 2021 (Actual)
Primary Completion Date
July 6, 2022 (Actual)
Study Completion Date
June 12, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
Chugai Pharmaceutical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Macular Edema, Branch Retinal Vein Occlusion
Keywords
BRVO
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
553 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Arm A: Faricimab Q4W (Part 1), Faricimab PTI (Part 2)
Arm Type
Experimental
Arm Description
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).
Arm Title
Arm B: Aflibercept Q4W (Part 1), Faricimab PTI (Part 2)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Faricimab
Other Intervention Name(s)
VABYSMO®, faricimab-svoa, RO6867461, RG7716
Intervention Description
Faricimab will be administered by intravitreal (IVT) injection as specified in each treatment arm.
Intervention Type
Drug
Intervention Name(s)
Aflibercept
Other Intervention Name(s)
Eylea
Intervention Description
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).
Intervention Type
Procedure
Intervention Name(s)
Sham Procedure
Intervention Description
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.
Primary Outcome Measure Information:
Title
Part 1: Change from Baseline in Best-Corrected Visual Acuity (BCVA) at Week 24
Time Frame
From Baseline to Week 24
Secondary Outcome Measure Information:
Title
Part 1: Change from Baseline in BCVA at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Week 24
Time Frame
Baseline and Week 24
Title
Part 1: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants with Absence of Intraretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants with Absence of Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid in the Study Eye at Specified Timepoints Through Week 24
Time Frame
Baseline, Weeks 4, 8, 12, 16, 20, and 24
Title
Part 1: Change from Baseline in National Eye Institute 25-Item Visual Functioning Questionnaire (NEI VFQ-25) Composite Score at Week 24
Time Frame
Baseline and Week 24
Title
Parts 1 and 2: Change from Baseline in BCVA at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Gaining ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Gaining ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Gaining ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Gaining >0 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Baseline at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Achieving ≥84 Letters (20/20 Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants Achieving ≥69 Letters (20/40 or Better Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants with ≤38 Letters (20/200 or Worse Snellen Equivalent) in BCVA at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Change from Baseline in NEI VFQ-25 Questionnaire Composite Score at Specified Timepoints Through Week 72
Time Frame
Baseline, Weeks 24, 48, and 72
Title
Parts 1 and 2: Change from Baseline in Central Subfield Thickness at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants with Absence of Macular Edema at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants with Absence of Subretinal Fluid at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Parts 1 and 2: Percentage of Participants with Absence of Intraretinal Fluid and Subretinal Fluid at Specified Timepoints Through Week 72
Time Frame
Baseline and every 4 weeks from Week 4 to Week 72
Title
Part 2: Change from Week 24 in BCVA at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 24 to Week 72
Title
Part 2: Percentage of Participants Avoiding a Loss of ≥15 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 24 to Week 72
Title
Part 2: Percentage of Participants Avoiding a Loss of ≥10 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 24 to Week 72
Title
Part 2: Percentage of Participants Avoiding a Loss of ≥5 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 24 to Week 72
Title
Part 2: Percentage of Participants Avoiding a Loss of >0 Letters in BCVA from Week 24 at Specified Timepoints Through Week 72
Time Frame
Every 4 weeks from Week 24 to Week 72
Title
Part 2: Percentage of Participants on Different Treatment Intervals at Week 68
Time Frame
Week 68
Title
Part 2: Number of Study Drug Injections Received from Week 24 Through Week 72
Time Frame
From Week 24 to Week 72
Title
Incidence and Severity of Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale
Time Frame
From Baseline until end of study (up to 72 weeks)
Title
Incidence and Severity of Non-Ocular Adverse Events, with Severity Determined According to Adverse Event Severity Grading Scale
Time Frame
From Baseline until end of study (up to 72 weeks)
Title
Plasma Concentration of Faricimab Over Time
Time Frame
Predose at Day 1, Weeks 4, 24, 28, 52, and 72
Title
Number of Participants with Anti-Drug Antibodies (ADAs) to Faricimab at Baseline and During the Study
Time Frame
Predose at Day 1 (Baseline), Weeks 4, 24, 28, 52, and 72
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
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
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
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 Colorado PC
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
Florida Eye Associates
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32901
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
Southern Vitreoretinal Assoc
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Retina Associates of Florida, LLC
City
Tampa
State/Province
Florida
ZIP/Postal Code
33609
Country
United States
Facility Name
Southeast Retina Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Georgia Retina PC
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060-1137
Country
United States
Facility Name
Retina Consultants of Hawaii
City
'Aiea
State/Province
Hawaii
ZIP/Postal Code
96701
Country
United States
Facility Name
University Retina and Macula Associates, PC
City
Oak Forest
State/Province
Illinois
ZIP/Postal Code
60452
Country
United States
Facility Name
Prairie Retina Center
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
Cumberland Valley Retina PC
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Tufts Medical Center; Ophthalmology
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Assoc Retinal Consultants PC
City
Royal Oak
State/Province
Michigan
ZIP/Postal Code
48073
Country
United States
Facility Name
VitreoRetinal Surgery, PLLC.; DBA Retina Consultants of Minnesota
City
Edina
State/Province
Minnesota
ZIP/Postal Code
55435
Country
United States
Facility Name
Midwest Vision Research Foundation
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Sierra Eye Associates
City
Reno
State/Province
Nevada
ZIP/Postal Code
89502
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
Graystone Eye
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Cincinnati Eye Institute
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
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
Retina Res Institute of Texas
City
Abilene
State/Province
Texas
ZIP/Postal Code
79606
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705-1169
Country
United States
Facility Name
Retina & Vitreous of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77401
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
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
Strategic Clinical Research Group, LLC
City
Willow Park
State/Province
Texas
ZIP/Postal Code
76087
Country
United States
Facility Name
Retina Associates of Utah, PLLC
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Fundacion Zambrano
City
Caba
ZIP/Postal Code
C1017AAO
Country
Argentina
Facility Name
Centro Oftalmológico Dr. Charles S.A.
City
Capital Federal
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Oftalmos
City
Capital Federal
ZIP/Postal Code
C1120AAN
Country
Argentina
Facility Name
Hospital Italiano; Ophtalmology
City
Capital Federal
ZIP/Postal Code
C1199ABC
Country
Argentina
Facility Name
Buenos Aires Mácula
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1061AAE
Country
Argentina
Facility Name
Oftar
City
Mendoza
ZIP/Postal Code
M5500GGK
Country
Argentina
Facility Name
Centro Oftalmólogos Especialistas
City
Rosario
ZIP/Postal Code
S2000ANJ
Country
Argentina
Facility Name
Grupo Laser Vision
City
Rosario
ZIP/Postal Code
S2000DLA
Country
Argentina
Facility Name
Organizacion Medica de Investigacion
City
San Nicolás
ZIP/Postal Code
C1015ABO
Country
Argentina
Facility Name
Strathfield Retina Clinic
City
Strathfield
State/Province
New South Wales
ZIP/Postal Code
2135
Country
Australia
Facility Name
Save Sight Institute
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Sydney Retina Clinic and Day Surgery
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2000
Country
Australia
Facility Name
Centre For Eye Research Australia
City
East Melbourne
State/Province
Victoria
ZIP/Postal Code
3002
Country
Australia
Facility Name
Retina Specialists Victoria
City
Rowville
State/Province
Victoria
ZIP/Postal Code
3178
Country
Australia
Facility Name
The Lions Eye Institute
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
LKH-Univ.Klinikum Graz; Universitäts-Augenklinik
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Hospital das Clinicas - UFRGS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-903
Country
Brazil
Facility Name
Botelho Hospital da Visao
City
Blumenau
State/Province
SC
ZIP/Postal Code
89052-504
Country
Brazil
Facility Name
Universidade Federal de Sao Paulo - UNIFESP*X; Oftalmologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
04023-062
Country
Brazil
Facility Name
Hosp de Olhos de Sorocaba
City
Sorocaba
State/Province
SP
ZIP/Postal Code
18031-060
Country
Brazil
Facility Name
Beijing Hospital of Ministry of Health
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The Second Hospital of Jilin University
City
Changchun
ZIP/Postal Code
130041
Country
China
Facility Name
West China Hospital, Sichuan University
City
Chengdu
ZIP/Postal Code
610041
Country
China
Facility Name
Zhongshan Ophthalmic Center, Sun Yat-sen University
City
Guangzhou City
ZIP/Postal Code
510060
Country
China
Facility Name
The 2nd Affiliated Hospital of Harbin Medical University
City
Harbin
ZIP/Postal Code
150001
Country
China
Facility Name
The Affiliated Eye Hospital of Nanjing Medical University
City
Nanjing City
ZIP/Postal Code
210029
Country
China
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
ZIP/Postal Code
200072
Country
China
Facility Name
Shanghai First People's Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
He Eye Specialist Shenyang Hospital
City
Shenyang City
ZIP/Postal Code
110034
Country
China
Facility Name
Tianjin Eye Hospital
City
Tianjin City
ZIP/Postal Code
300050
Country
China
Facility Name
Tianjin Medical University Eye Hospital
City
Tianjin City
ZIP/Postal Code
300070
Country
China
Facility Name
Eye Hospital, Wenzhou Medical University
City
Wenzhou City
ZIP/Postal Code
325027
Country
China
Facility Name
Renmin Hospital of Wuhan University
City
Wuhan
ZIP/Postal Code
430060
Country
China
Facility Name
Henan Provincial Eye Hosptial
City
Zhengzhou
Country
China
Facility Name
Faculty Hospital Ostrava; Ophthalmology clinic
City
Ostrava
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Faculty Hospital Kralovske Vinohrady; Ophthalmology clinic
City
Prague
ZIP/Postal Code
100 34
Country
Czechia
Facility Name
AXON Clinical
City
Prague
Country
Czechia
Facility Name
Nemocnice Sokolov
City
Sokolov
ZIP/Postal Code
356 01
Country
Czechia
Facility Name
Chi De Creteil; Ophtalmologie
City
Creteil
ZIP/Postal Code
94010
Country
France
Facility Name
Hopital Lariboisiere; Ophtalmologie
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Universitätsklinikum Freiburg, Klinik für Augenheilkunde
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Augenheilkunde
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Facility Name
Klinikum der Stadt Ludwigshafen am Rhein gGmbH; Augenklinik
City
Ludwigshafen
ZIP/Postal Code
67063
Country
Germany
Facility Name
Queen Mary Hospital; Department of Ophthalmology
City
Hong Kong
Country
Hong Kong
Facility Name
Hong Kong Eye Hospital; CUHK Eye Centre
City
Mongkok
Country
Hong Kong
Facility Name
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
Szegedi Tudományegyetem ÁOK; Department of Ophtalmology
City
Szeged
ZIP/Postal Code
6720
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 Ptv Policlinico Tor Vergata Di Roma;U.O.S.D. Patologie Renitiche
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
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 Ospedaliero-Universitaria Careggi; S.O.D. Oculistica
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Sugita Eye Hospital
City
Aichi
ZIP/Postal Code
460-0008
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
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
Southern TOHOKU Eye Clinic
City
Fukushima
ZIP/Postal Code
963-8052
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
Kyoto University Hospital
City
Kyoto
ZIP/Postal Code
606-8507
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
Tokyo Medical University Hachioji Medical Center
City
Tokyo
ZIP/Postal Code
193-0998
Country
Japan
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
602-739
Country
Korea, Republic of
Facility Name
Yeungnam University Medical Center
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
02447
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Specjalistyczny O?rodek 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
Gda?sk
ZIP/Postal Code
80-402
Country
Poland
Facility Name
Poradnia Okulistyczna i Salon Optyczny w Gliwicach- PRYZMAT
City
Gliwice
ZIP/Postal Code
44-100
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
Centrum Medyczne Pulawska SP. z o.o.
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Lens Clinic
City
Rybnik
ZIP/Postal Code
44-203
Country
Poland
Facility Name
Caminomed
City
Tarnowskie Góry
ZIP/Postal Code
42-600
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centro Hospitalar E Universitário de Coimbra EPE - Serviço Oftalmologia; Serviço Oftalmologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Espaco Medico Coimbra
City
Coimbra
ZIP/Postal Code
3030-163
Country
Portugal
Facility Name
Centro Hospitalar Universitário do Porto ? Hospital de Santo António; Servico de Oftalmologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Clinic Optimed
City
UFA
State/Province
Baskortostan
ZIP/Postal Code
450059
Country
Russian Federation
Facility Name
Clinics of Eye Diseases, LLC
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420066
Country
Russian Federation
Facility Name
?Intersec. Research and Technology Complex ?Eye Microsurgery? n a Fyodorov Irkutsk branch
City
Irkutsk
ZIP/Postal Code
664033
Country
Russian Federation
Facility Name
Singapore Eye Research Institute
City
Singapore
ZIP/Postal Code
168751
Country
Singapore
Facility Name
Tan Tock Seng Hospital; Ophthalmology Department
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
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 Baviera; Servicio Oftalmologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Rio Hortega; Servicio de Oftalmologia
City
Valladolid
ZIP/Postal Code
47012
Country
Spain
Facility Name
Changhua Christian Hospital; Department of Ophthalmology
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
Taipei Veterans General Hospital; Ophthalmology
City
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Chang Gung Medical Foundation - Linkou; Ophthalmology
City
Taoyuan
ZIP/Postal Code
333
Country
Taiwan
Facility Name
National Taiwan University Hospital; Ophthalmology
City
Zhongzheng Dist.
ZIP/Postal Code
10002
Country
Taiwan
Facility Name
Belfast Health and Social Care Trust, ROYAL VICTORIA HOSPITAL
City
Belfast
ZIP/Postal Code
BT12 6BA
Country
United Kingdom
Facility Name
Bristol Eye Hospital;Retinal Treatment and Research Unit
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
Gloucestershire Hospitals NHS Foundation Trust
City
Gloucestershire
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
St James University Hospital
City
Leeds
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Central Middlesex Hospital
City
London
ZIP/Postal Code
NW10 7NS
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/innovation/process/clinical-trials/data-sharing/).
Learn more about this trial
A Study to Evaluate the Efficacy and Safety of Faricimab in Participants With Macular Edema Secondary to Branch Retinal Vein Occlusion
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