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

Study Overview
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Brief Summary
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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).

Detailed Description
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A randomized, masked, controlled trial of safety and efficacy of suprachoroidal CLS-TA in combination with intravitreal aflibercept in subjects with macular edema following retinal vein occlusion

Official Title
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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

Conditions
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Macular Edema, Retinal Vein Occlusion

Intervention / Treatment
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* Drug: 4 mg CLS-TA
* Drug: Sham
* Drug: IVT aflibercept


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg CLS-TA + IVT aflibercept<br>Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept | Drug: 4 mg CLS-TA<br>* 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)<br>Drug: IVT aflibercept<br>* 2 mg intravitreal injection of aflibercept<br>* Other names: Eylea;|
| Active Comparator: sham + IVT aflibercept<br>Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept | Drug: Sham<br>* suprachoroidal sham procedure<br>* Other names: suprachoroidal sham;Drug: IVT aflibercept<br>* 2 mg intravitreal injection of aflibercept<br>* Other names: Eylea;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Number of Times a Subject Qualifies to be Administered IVT Aflibercept in Each Arm |  | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RVO, ME, Central Subfield Thickness, OCT, optical coherence tomography, cystoid macular edema, subretinal fluid, Eylea, aflibercept, anti-VEGF