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



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Ocular, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:1/11/2019
Start Date:December 8, 2017
End Date:May 22, 2018

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Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis

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.

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).

Inclusion Criteria:

- Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6

- Willing and able to provide written informed consent prior to any study procedures;
willing to comply with the instructions and attend all scheduled study visits

Exclusion Criteria:

- Received additional therapy for the treatment of uveitis or prohibited medication

- Require additional therapy for the treatment of uveitis or prohibited medication at
the time of the Crossover visit
We found this trial at
11
sites
2485 Hospital Drive
Mountain View, California 94040
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Mountain View, CA
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Ayer, Massachusetts 01940
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Ayer, MA
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Beltola Guwahati, Assam 78102
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Beltola Guwahati,
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Dallas, Texas 75231
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Dallas, TX
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Fargo, North Dakota 58103
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Fargo, ND
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Fort Lauderdale, Florida 33334
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Fort Lauderdale, FL
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Marietta, Georgia 30060
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Marietta, GA
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Phoenix, Arizona 85014
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Phoenix, AZ
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3616 Forbes Avenue
Pittsburgh, Pennsylvania 15213
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Pittsburgh, PA
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Portland, OR
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The Woodlands, Texas 77384
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The Woodlands, TX
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