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

COMPLETEDPHASE3

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

The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferative Vitreoretinopathy

NCT04136366•Aldeyra Therapeutics, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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 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

•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

Locations (23)

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

Key Dates

Start Date

November 15, 2019

Primary Completion Date

June 14, 2022

Completion Date

June 14, 2022

Last Updated

July 9, 2025

Enrollment

106

ACTUAL participants

Conditions

Proliferative Vitreoretinopathy

Interventions

ADX-2191 (intravitreal methotrexate 0.8%)

DRUG

Standard surgical care procedure

OTHER

Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

NCT06541574

Proliferative VitreoretinopathyRhegmatogenous Retinal Detachment

View study

COMPLETEDNA

Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

NCT06166914

Retinal DetachmentProliferative Vitreoretinopathy

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 9, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Prevention of ProliFerative Vitreoretinopathy with Intravitreal MethotreXate in Primary Retinal DEtachment Repair (FIXER) Trial

Efficacy of 5-fluorouracil and Low Molecular Weight Heparin in High-risk Pediatric Retinal Detachment

Intravitreal Aflibercept for the Prevention of Proliferative Vitreoretinopathy Following Retinal Detachment Repair

Prophylactic Intravitreal 5-Fluorouracil and Heparin to Prevent PVR in High-risk Patients With Retinal Detachment.

Comparative Study of 1000 Centistoke Versus 5000 Centistoke Silicone Oil for Repair of Complex Retinal Detachments

The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR