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

Completed · Phase 3 · Has a placebo group

Conditions studied: Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis

In brief

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.

Key facts

Study ID

NCT02595398

Run by

Clearside Biomedical, Inc.

People needed

160

Starts

2015-11-17

Expected to finish

2018-01-18

Last updated by the study team

2021-05-28

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
• Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns)
• Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters read (20/40 Snellen equivalent), in the study eye

You may not qualify if…

• Any active ocular disease or infection in the study eye other than uveitis
• Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications.
• Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
• Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Where it is running

• Retina Centers, PC — Tucson, Arizona, United States
• California Retina Consultants — Bakersfield, California, United States
• Retina-Vitreous Associates Medical Group — Beverly Hills, California, United States
• USC Eye Institute — Los Angeles, California, United States
• Northern California Retina Vitreous Associates Medical Group, Inc. — Mountain View, California, United States
• Orange County Retina Medical Group — Santa Ana, California, United States
• University of Colorado — Aurora, Colorado, United States
• Colorado Retina Associates — Golden, Colorado, United States
• Retina Group of Florida — Fort Lauderdale, Florida, United States
• Center for Retina and Macular Disease — Lakeland, Florida, United States
• Emory Eye Center Emory University — Atlanta, Georgia, United States
• Marietta Eye Clinic — Marietta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• University of Illinois at Chicago — Chicago, Illinois, United States
• Illinois Retina Associates, S.C. — Oak Park, Illinois, United States
• Midwest Eye Retina Practicing at Midwest Eye Institute — Indianapolis, Indiana, United States
• Elman Retina Group, PA — Baltimore, Maryland, United States
• The Retina Group of Washington — Chevy Chase, Maryland, United States
• Valley Eye Physicians and Surgeons, PC — Ayer, Massachusetts, United States
• Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
• Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution — Waltham, Massachusetts, United States
• Discover Vision Centers — Independence, Missouri, United States
• Metropolitan Eye Research & Surgery Institute — Palisades Park, New Jersey, United States
• Weill Cornell Medical College — New York, New York, United States
• Retinal Consultants of Arizona — Phoenix, Arizona, United States

Full record on ClinicalTrials.gov

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