NCT03097315

Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis

Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients With Non-Infectious Uveitis

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 38 (actual)
• Sponsor: Clearside Biomedical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

Detailed description

This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema. Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA 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	4 mg CLS-TA Suprachoriodal Injection	CLS-TA, 40 mg/mL (4 mg in 100 microliters), will be administered as a single injection at 2 timepoints

Timeline

• Start date: 2017-04-04
• Primary completion: 2018-01-24
• Completion: 2018-01-24
• First posted: 2017-03-31
• Last updated: 2021-06-23
• Results posted: 2021-06-15

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study