The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
- Conditions
- Proliferative Vitreoretinopathy
- Interventions
- Other: Standard surgical care procedureDrug: ADX-2191 (intravitreal methotrexate 0.8%)
- Registration Number
- NCT04136366
- Lead Sponsor
- Aldeyra Therapeutics, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 106
- 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 vitreoretionapthy 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Standard surgical care procedure Standard surgical care procedure Standard procedure performed. ADX-2191 (intravitreal methotrexate 0.8%) ADX-2191 (intravitreal methotrexate 0.8%) ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
- Primary Outcome Measures
Name Time Method Recurrent retinal detachment Efficacy assessment period (Week 1 to Week 24)
- Secondary Outcome Measures
Name Time Method Best-corrected visual acuity (BCVA) change from baseline Efficacy assessment period (Week 1 to Week 24)
Trial Locations
- Locations (23)
Mid Atlantic Retina
🇺🇸Philadelphia, Pennsylvania, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Associated Retinal Consultants
🇺🇸Royal Oak, Michigan, United States
Long Island VitreoRetinal Consultants
🇺🇸Forest Hills, New York, United States
University of Illinois at Chicago
🇺🇸Chicago, Illinois, United States
The Retina Institute
🇺🇸Saint Louis, Missouri, 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
Florida Retina Institute
🇺🇸Orlando, Florida, United States
Bascom Palmer Eye Institute
🇺🇸Palm Beach Gardens, Florida, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
Emory Eye Center
🇺🇸Atlanta, Georgia, United States
New England Retina Consultants
🇺🇸Springfield, Massachusetts, United States
Retina Consultants of Houston
🇺🇸Houston, Texas, United States
Retinal Consultants of Arizona
🇺🇸Phoenix, Arizona, United States
Vitreo-Retinal Surgery
🇺🇸Minneapolis, Minnesota, United States
Duke Health Center
🇺🇸Durham, North Carolina, United States
Kresge Eye Institute
🇺🇸Detroit, Michigan, United States
University of Washington
🇺🇸Seattle, Washington, United States
Illinois Retina Associates
🇺🇸Joliet, Illinois, United States
Mayo Clinic Ophthalmology
🇺🇸Rochester, Minnesota, United States
OHSU Casey Eye Institute
🇺🇸Portland, Oregon, United States