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



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Ocular, Ocular, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:9/20/2018
Start Date:November 17, 2015
End Date:January 18, 2018

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A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of 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.

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the
safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a
sham injection procedure in the treatment of subjects with macular edema associated with
non-infectious uveitis.

Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA
administered to the study eye or two sham injection procedures administered to the study eye
approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted
monthly up to 24 weeks (Visit 8).

Inclusion Criteria:

- Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)

- Diagnosis of macular edema associated with non-infectious uveitis

- Visual Acuity score of ≥ 5 letters read (20/800 Snellen equivalent) and ≤ 70 letters
read (20/40 Snellen equivalent), in the study eye

Exclusion Criteria:

- Any active ocular disease or infection in the study eye other than uveitis

- Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye

- Any uncontrolled systemic disease that, in the opinion of the Investigator, would
preclude participation in the study
We found this trial at
41
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634
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Waltham, MA
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1365 Clifton Road
Atlanta, Georgia 30322
432
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Atlanta, GA
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Aurora, Colorado 80045
1158
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Aurora, CO
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Austin, Texas 78705
1064
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Austin, TX
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Ayer, Massachusetts 01940
619
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Ayer, MA
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Bakersfield, California 93309
1983
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Bakersfield, CA
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Baltimore, Maryland 21237
349
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Baltimore, MD
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Bellevue, Washington 98004
2001
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Bellevue, WA
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Belmont, North Carolina 28012
343
mi
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Belmont, NC
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Beverly Hills, California 90211
1979
mi
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Beverly Hills, CA
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Boston, Massachusetts 02114
643
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Boston, MA
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Chevy Chase, Maryland 20815
324
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Chevy Chase, MD
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303 East Superior Street
Chicago, Illinois 60611
274
mi
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Chicago, IL
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2035 W Taylor St
Chicago, Illinois
(312) 996-4350
University of Illinois at Chicago A major research university in the heart of one of...
274
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Chicago, IL
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Dallas, Texas 75231
905
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Dallas, TX
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Fargo, North Dakota 58103
837
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Fargo, ND
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Fort Lauderdale, Florida 33334
966
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Fort Lauderdale, FL
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Golden, Colorado 80401
1174
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Golden, CO
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7021 Augusta Road
Greenville, South Carolina 29604
361
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Greenville, SC
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Houston, Texas 77030
995
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Houston, TX
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Hyderabad, Andhra Pradesh 500081
8293
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Hyderabad,
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Independence, Missouri 64055
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Independence, MO
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10300 North Illinois Street
Indianapolis, Indiana 46290
166
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Indianapolis, IN
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Lakeland, Florida 33805
822
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Lakeland, FL
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1450 San Pablo Street
Los Angeles, California 90033
1969
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Los Angeles, CA
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Marietta, Georgia 30060
423
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Marietta, GA
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2485 Hospital Drive
Mountain View, California 94040
2097
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Mountain View, CA
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New York, New York 10021
480
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New York, NY
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Norfolk, Virginia 23502
426
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Norfolk, VA
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Oak Park, Illinois 60304
281
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Oak Park, IL
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Palisades Park, New Jersey 07650
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Palisades Park, NJ
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Philadelphia, Pennsylvania 19107
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Philadelphia, PA
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Phoenix, Arizona 85014
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3616 Forbes Avenue
Pittsburgh, Pennsylvania 15213
165
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Pittsburgh, PA
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2027
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Portland, OR
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San Antonio, Texas
1138
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San Antonio, TX
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Santa Ana, California 92705
1960
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Santa Ana, CA
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SLingerlands, New York 12159
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SLingerlands, NY
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The Woodlands, Texas 77384
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The Woodlands, TX
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Tucson, Arizona 85704
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Winston-Salem, North Carolina 27157
306
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