The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

• Status: Recruiting
• Trial end date: 2022-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The GUARD Trial is a multi-center, randomized, controlled, adaptive Phase 3 clinical trial of repeated intravitreal injections of ADX-2191 versus standard-of-care for the prevention of proliferative vitreoretinopathy.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aldeyra Therapeutics, Inc.
• Treatments: Methotrexate

Criteria

Inclusion Criteria:

1. Subject is 18 years or older of any gender or race

2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury

3. Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits

4. Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial

Exclusion Criteria:

1. History of severe non-proliferative or proliferative diabetic retinopathy

2. Other planned eye surgery during the course of the trial

3. Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment