Suprachoroidal Injection of Triamcinolone Acetonide With IVT Aflibercept in Subjects With Macular Edema Following RVO

• Status: Terminated
• Trial end date: 2018-12-10
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clearside Biomedical, Inc.
• Treatments: Aflibercept; Triamcinolone; Triamcinolone Acetonide; Triamcinolone diacetate; Triamcinolone hexacetonide

Criteria

Inclusion Criteria:

• Has a clinical diagnosis of RVO in the study eye

• Has a CST of ≥ 300 µm in the study eye

• Has an ETDRS BCVA score of ≥ 20 letters read and ≤ 70 letters read in the study eye;

• Is naïve to local pharmacologic treatment for RVO in the study eye;

Exclusion Criteria:

• Any active ocular disease or infection in the study eye other than RVO

• History of glaucoma, intraocular pressure > 21 mmHg or ocular hypertension requiring more than one medication

• Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study

• Any evidence of neovascularization in the study eye