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 |
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.
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®.
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
sites
Univ of Nebraska Med Ctr A vital enterprise in the nation’s heartland, the University of...
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Cleveland Clinic Foundation The Cleveland Clinic (formally known as The Cleveland Clinic Foundation) is a...
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