NCT01789320

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 11 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®.

Conditions

• Uveitis
• Intermediate Uveitis
• Posterior Uveitis
• Panuveitis
• Noninfectious Uveitis

Interventions

Type	Name	Description
DRUG	triamcinolone acetonide (Triesence®)	4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space

Timeline

• Start date: 2013-02-01
• Primary completion: 2015-03-01
• Completion: 2015-03-01
• First posted: 2013-02-12
• Last updated: 2021-02-21
• Results posted: 2021-02-21

Locations

3 sites across 1 country: United States