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
Overview
- Phase
- Phase 3
- Intervention
- 4mg CLS-TA Suprachoriodal Injection
- Conditions
- Uveitis
- Sponsor
- Clearside Biomedical, Inc.
- Enrollment
- 160
- Locations
- 63
- Primary Endpoint
- Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Detailed 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).
Investigators
Eligibility Criteria
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.
Arms & Interventions
4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Intervention: 4mg CLS-TA Suprachoriodal Injection
Sham Procedure
Matching suprachoroidal syringe with sham procedure
Intervention: Sham Procedure
Outcomes
Primary Outcomes
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Time Frame: Baseline, 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.
Secondary Outcomes
- Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)(Baseline to 24 weeks)
- Mean Change From Baseline in Central Subfield Thickness(Baseline, 24 weeks)