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BALATON

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
Therapeutic Area Macular Edema
Principal Investigator Andre Witkin, MD
Min Age 18 Years
Gender Any
Contact Nancy Gee
617-636-5489
neecresearch@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04740905

Overview

This 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.

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.