Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis

Conditions
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Panuveitis, Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate

Intervention / Treatment
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* Drug: 4mg CLS-TA Suprachoriodal Injection
* Drug: Sham Procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior) Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness ≥ 300 microns) 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; subjects are not excluded if IOP ≤ 22 mmHg with no more than 2 IOP lowering medications. Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4mg CLS-TA Suprachoriodal Injection<br>Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA | Drug: 4mg CLS-TA Suprachoriodal Injection<br>* CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints<br>* Other names: Triamcinolone Acetonide;|
| Sham Comparator: Sham Procedure<br>Matching suprachoroidal syringe with sham procedure | Drug: Sham Procedure<br>* Sham procedure administered at 2 timepoints<br>* Other names: suprachoroidal sham;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Choroid, Choroidal Injection, Triamcinolone, Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide