this is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO
- Conditions
- Retinal Vein OcclusionTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2016-004648-12-PL
- Lead Sponsor
- Clearside Biomedical, Inc.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 460
•Has a clinical diagnosis of RVO in the study eye
•Has a CST of = 300 µm in the study eye
•Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye;
•Is naïve to local pharmacologic treatment for RVO in the study eye;
•Is at least 18 years of age
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 460
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
•Any active ocular disease or infection in the study eye other than RVO
•Intraocular pressure > 21mmHg in study eye at visit 1
• history of glaucoma, optic nerve head change consistent with glaucoma damage; or ocular hypertension in the study eye requiring more than one medication
•Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
•Any evidence of neovascularization in the study eye
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Proportion of subjects demonstrating = 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) [ Time Frame: 2 months ]<br>Based on best corrected visual acuity;Secondary Objective: - Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months ]<br>Based on ETDRS<br><br>- Mean change from baseline in central subfield thickness [ Time Frame: 6 months ]<br>Based on spectral domain optical coherence tomography<br>;Primary end point(s): proportion of subjects demonstrating = 15 letter improvement from Baseline in Early Treatment of Diabetic Retinopathy Study (ETDRS) BCVA at Visit 4 (Month 2).;Timepoint(s) of evaluation of this end point: during treatment period
- Secondary Outcome Measures
Name Time Method Secondary end point(s): ·Mean change from Baseline (Visit 2, Day 0) in BCVA at Visit 4 (Week 8) and Visit 8 (Week 24)<br>·Mean change from Baseline (Visit 2, Day 0) in CST at Visit 4 (Week 8) and Visit 8 (Week 24)<br>;Timepoint(s) of evaluation of this end point: during treatment period