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

Phase 3
Completed
Conditions
Proliferative Vitreoretinopathy
Interventions
Other: Standard surgical care procedure
Drug: 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
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
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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
Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Standard surgical care procedureStandard surgical care procedureStandard 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
NameTimeMethod
Recurrent retinal detachmentEfficacy assessment period (Week 1 to Week 24)
Secondary Outcome Measures
NameTimeMethod
Best-corrected visual acuity (BCVA) change from baselineEfficacy 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

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