Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis — PEACHTREE  

Uveitis Clinical Trial

Official title: A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis

Status Completed

Clinical Trial Summary

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Clinical Trial Description

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8). ;

Related Conditions & MeSH terms

• Macular Edema
• Panuveitis
• Uveitis
• Uveitis, Anterior
• Uveitis, Intermediate
• Uveitis, Posterior

• NCT number: NCT02595398
• Study type: Interventional
• Source: Clearside Biomedical, Inc.
• Status: Completed
• Phase: Phase 3
• Start date: November 17, 2015
• Completion date: January 18, 2018