Conditions: Uveitis Intermediate Uveitis Posterior Uveitis Panuveitis Noninfectious Uveitis
Keywords: uveitis intermediate uveitis posterior uveitis panuveitis noninfectious uveitis microneedle suprachoroidal space SCS inflammation ocular inflammatory conditions triamcinolone acetonide TA Triesence injection IVT intravitreal corticosteroid sympathetic ophthalmia temporal arteritis vitreous haze
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 11
Healthy volunteers: no

Brief summary:
This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Detailed description:
This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

Arms:
arm 1: TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)

Interventions: intervention 1: triamcinolone acetonide (Triesence®)
Intervention descriptions: intervention 1: 4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space

Protocol document: