Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (PEACHTREE)
- Conditions
- Health Condition 1: H208- Other iridocyclitisHealth Condition 2: H358- Other specified retinal disorders
- Registration Number
- CTRI/2016/09/007269
- Lead Sponsor
- Clearside Biomedical Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 70
1. Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior)
2. Diagnosis of macular edema associated with non-infectious uveitis (A retinal thickness of >= 300 microns in the central subfield)
3. Visual Acuity score of >= 5 letters read (20/800 Snellen equivalent) and <= 70 letters read (20/40 Snellen equivalent), in the study eye
4. Understands the language of the informed consent
5. At least 18 years of age
1. Any active ocular disease or infection in the study eye other than uveitis
2. Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye
3. Has high myopia in the study eye > -6 diopters or an axial length >= 26 mm
4. Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects with a change from baseline of â?¥ 15 letters in ETDRS BCVA at Visit 8 (24 weeks), subsequent to suprachoroidal injections of CLS-TA or sham injection procedures, in the study eyeTimepoint: Baseline to 24 Weeks
- Secondary Outcome Measures
Name Time Method Incidence of treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs), grouped by organ system, relatedness to study medication, and severityTimepoint: Baseline to 24 weeks;Mean change from baseline in Central Subfield Thickness (CST) as measured by SD-OCT at 24 weeksTimepoint: Baseline to 24 weeks