Overview

Suprachoroidal Injection of Triamcinolone Acetonide With IVT Anti-VEGF in Subjects With Macular Edema Following RVO

Status:
Terminated
Trial end date:
2018-12-18
Target enrollment:
0
Participant gender:
All
Summary
This Phase 3, multicenter, randomized, masked, controlled, parallel group study is designed to demonstrate that suprachoroidal (SC) CLS-TA administered with intravitreal (IVT) anti-VEGF agent in subjects with treatment naive RVO is superior to IVT anti-VEGF agent used alone.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Clearside Biomedical, Inc.
Treatments:
Bevacizumab
Ranibizumab
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