Clinical Trial: Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis
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 Summary: 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®.
Sponsor: Clearside Biomedical, Inc.
Current Primary Outcome:
- Incidence of adverse events [ Time Frame: Number of adverse events at 8 weeks ]
- Incidence of adverse events [ Time Frame: Number of adverse events at 6 months ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Central subfield thickness using optical coherence tomography (OCT) [ Time Frame: Change from baseline at 8 weeks and 26 weeks. ]
- Vitreous haze grade [ Time Frame: Change from baseline at 8 weeks and 26 weeks ]
- Change in intraocular pressure (IOP) [ Time Frame: Change from baseline in IOP at 8 weeks ]
Original Secondary Outcome: Same as current
Information By: Clearside Biomedical, Inc.
Dates:
Date Received: February 5, 2013
Date Started: February 2013
Date Completion:
Last Updated: July 25, 2016
Last Verified: July 2016