this is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment naïve subjects with RVO

Phase 1

• Conditions: Retinal Vein Occlusion; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2016-004648-12-GB
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-04-27
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 460

Inclusion Criteria

•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

Exclusion Criteria

•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