Trials / Completed
CompletedNCT02255032
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 22 (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 triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.
Detailed description
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA. The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates. Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 4 mg CLS-TA | 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
| DRUG | 0.8 mg CLS-TA | 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension) |
Timeline
- Start date
- 2014-10-01
- Primary completion
- 2015-12-01
- Completion
- 2016-01-01
- First posted
- 2014-10-02
- Last updated
- 2021-02-08
- Results posted
- 2021-02-08
Locations
11 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02255032. Inclusion in this directory is not an endorsement.