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Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Uveitis Clinical Trial

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

Clinical Trial 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.

Clinical Trial 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®. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT01789320
Study type Interventional
Source Clearside Biomedical, Inc.
Contact
Status Completed
Phase Phase 1/Phase 2
Start date February 2013
Completion date March 2015
View Details
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