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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595398
Other study ID # CLS1001-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 17, 2015
Est. completion date January 18, 2018

Study information

Verified date May 2021
Source Clearside Biomedical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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).


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Study Design


Intervention

Drug:
4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham Procedure
Sham procedure administered at 2 timepoints

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Sponsors (1)

Lead Sponsor Collaborator
Clearside Biomedical, Inc.

Countries where clinical trial is conducted

United States,  India,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Demonstrating = 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. Baseline, 24 weeks
Secondary Mean Change From Baseline in Central Subfield Thickness Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema. Only images that were gradable by the central reading center were included in the analysis. Baseline, 24 weeks
Secondary Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit. Baseline to 24 weeks
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