Overview

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

Status:
Completed
Trial end date:
2016-03-01
Target enrollment:
0
Participant gender:
All
Summary
A phase 2, multicenter, randomized, active-controlled, masked, parallel arm study designed to evaluate the safety and efficacy of a single suprachoroidal injection of CLS-TA, triamcinolone acetonide injectable suspension, given along with an intravitreal (IVT) injection of aflibercept compared to IVT aflibercept alone in subjects with retinal vein occlusion (RVO).
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clearside Biomedical, Inc.
Treatments:
Aflibercept
Polystyrene sulfonic acid
Triamcinolone Acetonide
Criteria
Inclusion Criteria:

- diagnosis of macular edema following RVO

- History of ME ≤ 12 months

- 20-70 letters inclusive BCVA using ETDRS

Exclusion Criteria:

- has had an IVT injection of anti-VEGF for RVO in the study eye

- has had a corticosteroid injection in the past 3 months in the study eye

- any uncontrolled ophthalmic condition in the study eye other than RVO