This is a phase 3, multicenter, randomized, masked, controlled, parallel group study of 49 week-duration in treatment naïve subjects with RVO.

Phase 1

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

• Registration Number: EUCTR2017-002089-37-GB
• Lead Sponsor: Clearside Biomedical, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-04-30
• Last Update Posted: 20 July 2020

Recruitment & Eligibility

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

Inclusion Criteria

1. Has a clinical diagnosis of RVO in the study eye within = 6 months screening;
2. Has a CST of = 300 µm in the study eye as measured by spectral-domain optical coherence tomography (SD-OCT) with intraretinal or subretinal fluid and confirmed by the central reading center (CRC);
3. Has an ETDRS BCVA score of = 20 letters read and = 70 letters read in the study eye; at least 20 letters in the non-study eye;
4. Is naïve to local pharmacologic treatment for RVO in the study eye;
5. Is at least 18 years of age, understands the language of the informed consent and is willing and able to provide written informed consent before any study procedures, and is willing to comply with the instructions and attend all scheduled study visits.

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) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

* macular edema with etiology 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