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COMPLETEDPhase 3NCT04136366

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

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 v...

Lead sponsor: Aldeyra Therapeutics, Inc.•23 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Aldeyra Therapeutics, Inc.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 9, 2025Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE3

Enrollment106

Start dateNov 2019

Last updatedJul 9, 2025

Condition

Proliferative Vitreoretinopathy

Locations shown

Retinal Consultants of Arizona

Phoenix, Arizona

University of California Los Angeles

Los Angeles, California

Florida Retina Institute

Orlando, Florida

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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: May 10, 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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