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

Status Completed

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®. ;

Related Conditions & MeSH terms

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

• NCT number: NCT01789320
• Study type: Interventional
• Source: Clearside Biomedical, Inc.
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: February 2013
• Completion date: March 2015