NCT02595398

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

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
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 160 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Uveitis
• Uveitis, Posterior
• Uveitis, Anterior
• Uveitis, Intermediate
• Panuveitis

Interventions

Type	Name	Description
DRUG	4mg CLS-TA Suprachoriodal Injection	CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
DRUG	Sham Procedure	Sham procedure administered at 2 timepoints

Timeline

• Start date: 2015-11-17
• Primary completion: 2018-01-18
• Completion: 2018-01-18
• First posted: 2015-11-03
• Last updated: 2021-05-28
• Results posted: 2021-04-28

Locations

64 sites across 3 countries: United States, India, Israel

Regulatory

• FDA-regulated drug study