Last updated on October 2017

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

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Tiffany Lin

Retinal Consultants of Arizona
Phoenix, AZ United States
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Tiffany Lin

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

Retina Group of Florida
Fort Lauderdale, FL United States
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Tiffany Lin

Marietta Eye Clinic
Marietta, GA United States
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Tiffany Lin

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

Bergstrom Eye Research
Fargo, ND United States
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Tiffany Lin

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

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

Texas Retina Associates
Dallas, TX United States
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Tiffany Lin

Retina Consultants of Houston
The Woodlands, TX United States
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Tiffany Lin

Sri Sankaradeva Nethralaya
Beltola Guwahati, India
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Tiffany Lin

Dr Rajendra Prasad Centre for Ophthalmic Sciences
Ansari Nagar, India
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Tiffany Lin

JSS Hospital
Karnataka, India
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Tiffany Lin

Sankara Eye Hospital
Tamil Nadu, India
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Tiffany Lin

King George's Medical University
Uttar Pradesh, India
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Tiffany Lin

Disha Eye Hospitals Pvt. Ltd.
West Bengal, India
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