Clearside Biomedical CLS1003-301

Active Clinical Trials // Feb 07 2018

Clearside Biomedical CLS1003-301

A Randomized, Masked, Controlled Trial to Study the Safety and Efficacy of Suprachoroidal CLS-TA in Conjunction with Intravitreal Aflibercept in Subjects with Retinal Vein Occlusion

Sponsor:  Clearside Biomedical, Inc.

Principal Investigator: Jonathan Chang, MD

Study Coordinator: Kris Dietzman

STUDY OBJECTIVES AND PURPOSE

The purpose of this study is to demonstrate the safety and efficacy of SC CLS-TA in conjunction with IVT aflibercept in subjects with RVO.

This is a Phase 3, multicenter, randomized, masked, controlled, parallel group study of 12 months duration in treatment-naïve subjects with RVO. This study is projected to enroll approximately 460 subjects, randomly assigned 1:1 to one of two treatment groups stratified by disease (BRVO, CRVO).

The study design includes 12 clinic visits over approximately 50 weeks

Study Drug:

Active: IVT aflibercept (2 mg/0.05 mL) + CLS-TA (4 mg/100 μL) SC injections

Control: IVT aflibercept (2 mg/0.05 mL) injection + sham SC procedure

Inclusion Criteria

Individuals are eligible for participation in this study if he/she meets the following criteria:

1. Has a clinical diagnosis of RVO in the study eye within ≤ 9 months screening;

2. Has a CST of ≥ 300 µm in the study eye as measured by spectral-domain optical coherence tomography (SD-OCT) with or without subretinal fluid and confirmed by the central reading center (CRC);

3. Has an ETDRS BCVA score of ≥ 5 letters read and ≤ 70 letters read in the 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.

 

For more information, contact Kris Dietzman at 608-263-9035