Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis

Study Overview
=================
Brief Summary
-----------------
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.

Detailed Description
-----------------
This is a Phase 2, randomized, masked, multicenter study to assess the safety and efficacy of two different doses of CLS-TA in the treatment of subjects with macular edema following non-infectious uveitis. Each subject will receive a single suprachoroidal injection of CLS-TA. The subjects enrolled in this study will be chosen from subjects with macular edema following non-infectious uveitis. A single injection will be administered via the Clearside microinjector into the suprachoroidal space. The dose injected will either be 4 mg or 0.8 mg of CLS-TA in a total volume of 100 μL. The dose they receive will depend on what their randomization code dictates. Subjects will be monitored for safety and efficacy for approximately 8 weeks following treatment.

Official Title
-----------------
A Randomized, Masked, Multicenter Study to Assess the Safety and Efficacy of CLS-TA, Triamcinolone Acetonide Injectable Suspension in the Treatment of Subjects With Macular Edema Following Uveitis

Conditions
-----------------
Uveitis, Macular Edema, Uveitis, Posterior, Uveitis, Anterior, Panuveitis, Uveitis, Intermediate

Intervention / Treatment
-----------------
* Drug: 4 mg CLS-TA
* Drug: 0.8 mg CLS-TA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of noninfectious uveitis diagnosis of macular edema associated with noninfectious uveitis Exclusion Criteria: any ocular trauma within the immediate 6 months prior to treatment any photocoagulation or cryotherapy in the 6 months prior to treatment any IVT injection of anti-VEGF treatment in the 2 months prior to treatment any eye diseases other than uveitis and ME that could compromise central visual acuity any previous suprachoroidal injection of triamcinolone acetonide in the study eye

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 4 mg CLS-TA<br>Single unilateral, suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA | Drug: 4 mg CLS-TA<br>* 40 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)<br>|
| Experimental: 0.8 mg CLS-TA<br>Single unilateral, suprachoroidal injection of 8 mg/mL (0.8 mg in 100 µL) of CLS-TA | Drug: 0.8 mg CLS-TA<br>* 8 mg/mL CLS-TA, Clearside's formulation of TA (CLS-TA, triamcinolone acetonide injectable suspension)<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis |  | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
suprachoroidal space, uveitis, macular edema, UME, posterior uveitis, anterior uveitis, panuveitis, intermediate uveitis, noninfectious uveitis, triamcinolone acetonide, injection, microneedle, intravitreal injection, corticosteroid, CME, choroid, retina, microinjection, SCS