The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
NCT ID: NCT04136366
Last Updated: 2025-07-09
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
106 participants
INTERVENTIONAL
2019-11-15
2022-06-14
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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ADX-2191 (intravitreal methotrexate 0.8%)
ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
ADX-2191 (intravitreal methotrexate 0.8%)
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Standard surgical care procedure
Standard procedure performed.
Standard surgical care procedure
Standard surgical care performed upon completion of pars plana vitrectomy
Interventions
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ADX-2191 (intravitreal methotrexate 0.8%)
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Standard surgical care procedure
Standard surgical care performed upon completion of pars plana vitrectomy
Eligibility Criteria
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Inclusion Criteria
2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretinopathy 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
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
18 Years
ALL
No
Sponsors
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Aldeyra Therapeutics, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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ADX-2191-PVR-001
Identifier Type: -
Identifier Source: org_study_id
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