The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
1 other identifier
interventional
106
1 country
23
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2019
Typical duration for phase_3
23 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 21, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
November 15, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 14, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 14, 2022
CompletedResults Posted
Study results publicly available
July 9, 2025
CompletedJuly 9, 2025
October 1, 2022
2.6 years
October 21, 2019
June 17, 2025
July 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrent Retinal Detachment Compared to Historical Rates
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
Efficacy assessment period (Week 1 to Week 24)
Secondary Outcomes (5)
Number of Subjects With Recurrent Retinal Detachment
Efficacy assessment period (Week 1 to Week 24)
Best-corrected Visual Acuity
Efficacy assessment period (Week 1 to Week 24)
Macular Epiretinal Membrane
Week 24
Intraocular Pressure Less Than 5 mmHg for Study Eye
Week 24
Central Macular Subfield Thickness
Week 24
Study Arms (2)
ADX-2191 (intravitreal methotrexate 0.8%)
EXPERIMENTALADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.
Standard surgical care procedure
ACTIVE COMPARATORStandard procedure performed.
Interventions
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Standard surgical care performed upon completion of pars plana vitrectomy
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (23)
Retinal Consultants of Arizona
Phoenix, Arizona, 85053, United States
University of California Los Angeles
Los Angeles, California, 90095, United States
Florida Retina Institute
Orlando, Florida, 32806, United States
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, 33418, United States
Emory Eye Center
Atlanta, Georgia, 30322, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Illinois Retina Associates
Joliet, Illinois, 60435, United States
University of Iowa
Iowa City, Iowa, 52242, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Massachusetts Eye and Ear
Boston, Massachusetts, 02214, United States
New England Retina Consultants
Springfield, Massachusetts, 01107, United States
Kresge Eye Institute
Detroit, Michigan, 48201, United States
Associated Retinal Consultants
Royal Oak, Michigan, 48073, United States
Vitreo-Retinal Surgery
Minneapolis, Minnesota, 55432, United States
Mayo Clinic Ophthalmology
Rochester, Minnesota, 55905, United States
The Retina Institute
St Louis, Missouri, 63128, United States
Long Island VitreoRetinal Consultants
Forest Hills, New York, 11375, United States
Duke Health Center
Durham, North Carolina, 27705, United States
OHSU Casey Eye Institute
Portland, Oregon, 97239, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
University of Washington
Seattle, Washington, 98104, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Aldeyra Therapeutics, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2019
First Posted
October 23, 2019
Study Start
November 15, 2019
Primary Completion
June 14, 2022
Study Completion
June 14, 2022
Last Updated
July 9, 2025
Results First Posted
July 9, 2025
Record last verified: 2022-10