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



Status:Completed
Conditions:Cardiology, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:2/11/2018
Start Date:January 2015
End Date:March 2016

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TANZANITE: Safety and Efficacy of Suprachoroidal CLS-TA in Combination With Intravitreal Aflibercept in Subjects With Macular Edema Following Retinal Vein Occlusion

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).


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
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