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NCT02595398 · ClinicalTrials.gov registry record · Phase 3
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
A Phase 3 study of Uveitis and Uveitis, Posterior, sponsored by Clearside Biomedical.
- Completed
- Registry status
- Phase 3
- Development phase
- 160
- Enrollment target
- 20
- Study locations
NCT02595398: Completed Phase 3 study of Uveitis and Uveitis, Posterior, sponsored by Clearside Biomedical.
NCT02595398 is a Phase 3 study of Uveitis and Uveitis, Posterior that has completed, run by Clearside Biomedical. The registered enrollment target is 160 participants, below the 609-participant average among 19 other Uveitis trials with a reported enrollment target (74% lower). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02595398, a Phase 3 study of Uveitis and Uveitis, Posterior, has completed, sponsored by Clearside Biomedical.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 160 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.
Conditions Studied
Interventions
- DRUG Sham Procedure
- DRUG 4mg CLS-TA Suprachoriodal Injection
Study Locations (20)
California
- California Retina Consultants - Bakersfield
- Retina-Vitreous Associates Medical Group - Beverly Hills
- USC Eye Institute - Los Angeles
- Northern California Retina Vitreous Associates Medical Group, Inc. - Mountain View
- Orange County Retina Medical Group - Santa Ana
Illinois
- Northwestern University - Chicago
- University of Illinois at Chicago - Chicago
- Illinois Retina Associates, S.C. - Oak Park
Arizona
- Retinal Consultants of Arizona - Phoenix
- Retina Centers, PC - Tucson
Colorado
- University of Colorado - Aurora
- Colorado Retina Associates - Golden
Florida
- Retina Group of Florida - Fort Lauderdale
- Center for Retina and Macular Disease - Lakeland
Georgia
- Emory Eye Center Emory University - Atlanta
- Marietta Eye Clinic - Marietta
Maryland
- Elman Retina Group, PA - Baltimore
- The Retina Group of Washington - Chevy Chase
Indiana
- Midwest Eye Retina Practicing at Midwest Eye Institute - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2015-11-17 |
| Est. Completion | 2018-01-18 |
| Phase | Phase 3 |
What the finished NCT02595398 record still lists
NCT02595398 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, below the 609-participant average among 19 other Uveitis trials with a reported enrollment target (74% lower).
The record links to 5 conditions, with Uveitis appearing as the primary indexed condition, and to 2 interventions - of which Sham Procedure is the first listed.
NCT02595398 names 20 study sites across 9 states, led by California, Illinois, Arizona.
Frequently Asked Questions
What is clinical trial NCT02595398 about?
NCT02595398 is a clinical study titled "Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis". 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.
What is the current status of trial NCT02595398?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 160 participants. The study started on 2015-11-17. Estimated completion is 2018-01-18.
What conditions does trial NCT02595398 study?
This clinical trial studies the following conditions: Uveitis, Uveitis, Posterior, Uveitis, Intermediate, Uveitis, Anterior, Panuveitis.
What interventions are being tested in trial NCT02595398?
The interventions under investigation include: Sham Procedure (DRUG), 4mg CLS-TA Suprachoriodal Injection (DRUG).
Who is sponsoring clinical trial NCT02595398?
This trial is sponsored by Clearside Biomedical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02595398 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Uveitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02595398's enrollment target sits among peer trials
160 9th of 19 higher than 11 of 19 other Uveitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Uveitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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