Last updated on September 2018

Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301


Brief description of study

The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.

Detailed Study Description

This is a non-interventional extension study of up to 6 months for subjects completing the Parent study. The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis. The study design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).

Clinical Study Identifier: NCT02952001

Contact Investigators or Research Sites near you

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Tiffany Lin

Retinal Consultants of Arizona
Phoenix, AZ United States

Tiffany Lin

Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, CA United States

Tiffany Lin

Retina Group of Florida
Fort Lauderdale, FL United States

Tiffany Lin

Marietta Eye Clinic
Marietta, GA United States

Tiffany Lin

Valley Eye Physicians and Surgeons, PC
Ayer, MA United States

Tiffany Lin

Bergstrom Eye Research
Fargo, ND United States

Tiffany Lin

Oregon Health & Science University Casey Eye Institute
Portland, OR United States

Tiffany Lin

University of Pittsburgh Medical Center Eye Center
Pittsburgh, PA United States

Tiffany Lin

Texas Retina Associates
Dallas, TX United States

Tiffany Lin

Retina Consultants of Houston
The Woodlands, TX United States

Tiffany Lin

Sri Sankaradeva Nethralaya
Beltola Guwahati, India

Tiffany Lin

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Ansari Nagar, India

Tiffany Lin

JSS Hospital
Karnataka, India

Tiffany Lin

Sankara Eye Hospital
Tamil Nadu, India

Tiffany Lin

King George's Medical University
Uttar Pradesh, India

Tiffany Lin

Disha Eye Hospitals Pvt. Ltd.
West Bengal, India