The study will evaluate the efficacy, safety and pharmacokinetics of faricimab compared with aflibercept in patients with macular edema due to branch retinal vein occlusion (BRVO) up to the primary endpoint at Week 24.
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
Macular degeneration
All genders
18+
Recruiting now
Overview
Principal Investigator: Andre Witkin, MD
Contact Us
Nancy Gee
Study details
Inclusion Criteria
- Foveal center-involved macular edema due to BRVO, diagnosed no longer than 4 months prior
- Visual Acuity 20/40 to 20/400 approximate Snellen equivalent
- CST >325 um, as measured on Spectralis SD-OCT, or >315 um, as measured on Cirrus SD-OCT or Topcon
Exclusion Criteria
- Any major illness or major surgical procedure within 1 month before screening
- Active cancer within the 12 months prior
- Any systemic corticosteroid use
Study Requirements
The study will consist of a screening period of up to 28 days and an approximately 68-week Dosing period with visits every 4 weeks, followed by the final study visit at Week 72.