Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis



Status:Completed
Conditions:Cervical Cancer, Cervical Cancer, Cardiology, Ocular, Ocular, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:January 2016

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A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis

The study is designed to evaluate the safety and efficacy of triamcinolone acetonide,
CLS-TA, in subjects with macular edema following non-infectious uveitis. A single
suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects
with macular edema following non-infectious uveitis.

This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy
of two different doses of CLS-TA in the treatment of subjects with macular edema following
non-infectious uveitis. Each subject will receive a single suprachoroidal injection of
CLS-TA.

The subjects enrolled in this study will be chosen from subjects with macular edema
following non-infectious uveitis. A single injection will be administered via the Clearside
microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg
of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their
randomization code dictates.

Subjects will be monitored for safety and efficacy for approximately 8 weeks following
treatment.

Inclusion Criteria:

- diagnosis of noninfectious uveitis

- diagnosis of macular edema associated with noninfectious uveitis

Exclusion Criteria:

- any ocular trauma within the immediate 6 months prior to treatment

- any photocoagulation or cryotherapy in the 6 months prior to treatment

- any IVT injection of anti-VEGF treatment in the 2 months prior to treatment

- any eye diseases other than uveitis and ME that could compromise central visual
acuity

- any previous suprachoroidal injection of triamcinolone acetonide in the study eye
We found this trial at
11
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Cambridge, MA
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Fargo, ND
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New York, NY
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Omaha, NE
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Winston Salem, North Carolina 27157
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Winston Salem, NC
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