Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis



Status:Completed
Conditions:Cervical Cancer, Ocular
Therapuetic Areas:Oncology, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:February 2013
End Date:March 2015

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Open-Label, Safety and Tolerability Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle in Subjects With Non-Infectious Uveitis

This study is designed to determine the safety and tolerability of a single microinjection
of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who
have non-infectious uveitis.

This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and
procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The
subjects enrolled in this study will be chosen from subjects with non-infectious
intermediate, posterior and pan-uveitis. The injection will only be administered to a single
eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be
injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable
suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects
will be followed for 26 weeks following treatment with TRIESENCE®.

Inclusion Criteria:

- diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria:

- any ocular trauma within the past 6 months in the study eye

- any injection of intraocular corticosteroids or steroid implant or the Ozurdex®
implant in the 6 months prior to the study treatment, or any prior use of Retisert™
in the study eye

- any uncontrolled systemic disease that would preclude participation in the study or
put the subject at risk due to study treatment or procedures

- have a known HIV infection or other immunodeficiency disease for which corticosteroid
therapy would be contraindicated

- are monocular

- have ocular hypertension

- history of any intraocular surgery in the study eye

- presence of an anterior staphyloma in the study eye
We found this trial at
3
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303 East Superior Street
Chicago, Illinois 60611
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2049 E 100th St
Cleveland, Ohio 44106
(216) 444-2200
Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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Emile St
Omaha, Nebraska 68198
(402) 559-4000
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Omaha, NE
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