TOPAZ - Sponsored by Clearside Biomedical, Inc.Active Study | Duration: 52 weeks
TOPAZ is a phase 3, multicenter, randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal (SC) CLS-TA administered adjunctively with an intravitreal anti-VEGF agent in subjects with Retinal Vein Occlusions. The primary objective is to demonstrate this method of treatment in patients with macular edema secondary to retinal vein occlusion as superior to anti-VEGF therapy alone using Best Corrected Visual Acuity outcome. This study is projected to enroll 460 eligible patients who have been newly diagnosed (<9 months) and are naïve to prior treatments. Patients will be randomly assigned into four treatment arms in a 1:1:1:1 ratio stratified by disease (BRVO, CRVO, and HRVO) receiving Lucentis or Avastin + CLS-TA SC injection in the active treatment arms, or control arms receiving Lucentis + Sham, or Avastin + Sham. Trial participation is 12 months.