TOPAZ - Sponsored by Clearside Biomedical, Inc.Active Study | Duration: 50 weeks
TOPAZ is a randomized, masked, controlled trial to study the safety and efficacy of suprachoroidal (SC) CLS-TA administered adjunctively with Intravitreal Aflibercept (Eylea®) in subjects with newly diagnosed 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 IVT alone using Best Corrected Visual Acuity outcome. This Phase 3, multicenter, randomized, masked, controlled parallel group will be treated with suprachoroidal injections in a novelty drug micro-injector delivery to precisely administer the medication to more rapidly resolve Macular Edema and improve vision, as compared to the current traditional monotherapy for Retinal Vein Occlusion. This study is projected to enroll 460 eligible subjects who have been newly diagnosed (<9 months) and are naïve to prior treatment, randomly assigned 1:1 of stratified Branch Retinal Vein Occlusion and Central Retinal Vein Occlusion groups.
Patients are treated and followed through 12 clinic visits over 50 weeks.