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 |
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.
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).
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
sites
University of Illinois at Chicago A major research university in the heart of one of...
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10300 North Illinois Street
Indianapolis, Indiana 46290
Indianapolis, Indiana 46290
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2485 Hospital Drive
Mountain View, California 94040
Mountain View, California 94040
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3616 Forbes Avenue
Pittsburgh, Pennsylvania 15213
Pittsburgh, Pennsylvania 15213
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Waltham, Massachusetts 01741
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