Conditions: Macular Edema Retinal Vein Occlusion
Keywords: RVO ME Central Subfield Thickness OCT optical coherence tomography cystoid macular edema subretinal fluid Eylea aflibercept anti-VEGF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 46
Healthy volunteers: no

Brief 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).

Detailed description:
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

Arms:
arm 1: Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA following a 2 mg intravitreal injection of aflibercept arm 2: Single unilateral, suprachoroidal sham procedure following a 2 mg intravitreal injection of aflibercept

Interventions: intervention 1: 4 mg CLS-TA intervention 2: Sham intervention 3: IVT aflibercept
Intervention descriptions: intervention 1: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) intervention 2: suprachoroidal sham procedure intervention 3: 2 mg intravitreal injection of aflibercept

Protocol document: