Conditions: Uveitis Macular Edema Uveitis, Posterior Uveitis, Anterior Panuveitis Uveitis, Intermediate
Keywords: uveitis macular edema UME posterior uveitis anterior uveitis panuveitis intermediate uveitis noninfectious uveitis triamcinolone acetonide suprachoroidal space injection microneedle intravitreal injection corticosteroid CME choroid retina microinjection SCS
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 22
Healthy volunteers: no

Brief summary:
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Detailed description:
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Arms:
arm 1: Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA arm 2: Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA

Interventions: intervention 1: 4 mg CLS-TA intervention 2: 0.8 mg CLS-TA
Intervention descriptions: intervention 1: 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) intervention 2: 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)

Protocol document: