Expired Study
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Santa Ana, California 92705


Purpose:

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.


Study summary:

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).


Criteria:

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


NCT ID:

NCT02595398


Primary Contact:

Study Director
Jennifer Kissner, PhD
Clearside Biomedical, Inc.


Backup Contact:

N/A


Location Contact:

Santa Ana, California 92705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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