The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Completed · Phase 3
Conditions studied: Proliferative Vitreoretinopathy
In brief
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.
Key facts
- Study ID
- NCT04136366
- Run by
- Aldeyra Therapeutics, Inc.
- People needed
- 106
- Starts
- 2019-11-15
- Expected to finish
- 2022-06-14
- Last updated by the study team
- 2025-07-09
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Subject is 18 years or older of any gender or race
- Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretinopathy or open globe injury
- Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
- Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial
You may not qualify if…
- History of severe non-proliferative or proliferative diabetic retinopathy
- Other planned eye surgery during the course of the trial
- Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment
Where it is running
- Retinal Consultants of Arizona — Phoenix, Arizona, United States
- University of California Los Angeles — Los Angeles, California, United States
- Florida Retina Institute — Orlando, Florida, United States
- Bascom Palmer Eye Institute — Palm Beach Gardens, Florida, United States
- Emory Eye Center — Atlanta, Georgia, United States
- University of Illinois at Chicago — Chicago, Illinois, United States
- Illinois Retina Associates — Joliet, Illinois, United States
- University of Iowa — Iowa City, Iowa, United States
- Tufts Medical Center — Boston, Massachusetts, United States
- Ophthalmic Consultants of Boston — Boston, Massachusetts, United States
- Massachusetts Eye and Ear — Boston, Massachusetts, United States
- New England Retina Consultants — Springfield, Massachusetts, United States
- Kresge Eye Institute — Detroit, Michigan, United States
- Associated Retinal Consultants — Royal Oak, Michigan, United States
- Vitreo-Retinal Surgery — Minneapolis, Minnesota, United States
- Mayo Clinic Ophthalmology — Rochester, Minnesota, United States
- The Retina Institute — St Louis, Missouri, United States
- Long Island VitreoRetinal Consultants — Forest Hills, New York, United States
- Duke Health Center — Durham, North Carolina, United States
- OHSU Casey Eye Institute — Portland, Oregon, United States
- Mid Atlantic Retina — Philadelphia, Pennsylvania, United States
- Retina Consultants of Houston — Houston, Texas, United States
- University of Washington — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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