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

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.

Study Overview

• Status: Completed
• Conditions: Proliferative Vitreoretinopathy
• Intervention / Treatment: Drug: ADX-2191 (intravitreal methotrexate 0.8%); Other: Standard surgical care procedure

• Study Type: Interventional
• Enrollment (Actual): 106
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85053
      • Retinal Consultants of Arizona
  • California
    • Los Angeles, California, United States, 90095
      • University of California Los Angeles
  • Florida
    • Orlando, Florida, United States, 32806
      • Florida Retina Institute
    • Palm Beach Gardens, Florida, United States, 33418
      • Bascom Palmer Eye Institute
  • Georgia
    • Atlanta, Georgia, United States, 30322
      • Emory Eye Center
  • Illinois
    • Chicago, Illinois, United States, 60612
      • University of Illinois at Chicago
    • Joliet, Illinois, United States, 60435
      • Illinois Retina Associates
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
    • Boston, Massachusetts, United States, 02214
      • Massachusetts Eye and Ear
    • Springfield, Massachusetts, United States, 01107
      • New England Retina Consultants
  • Michigan
    • Detroit, Michigan, United States, 48201
      • Kresge Eye Institute
    • Royal Oak, Michigan, United States, 48073
      • Associated Retinal Consultants
  • Minnesota
    • Minneapolis, Minnesota, United States, 55432
      • Vitreo-Retinal Surgery
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Ophthalmology
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • The Retina Institute
  • New York
    • Forest Hills, New York, United States, 11375
      • Long Island Vitreoretinal Consultants
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke Health Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • OHSU Casey Eye Institute
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Mid Atlantic Retina
  • Texas
    • Houston, Texas, United States, 77030
      • Retina Consultants of Houston
  • Washington
    • Seattle, Washington, United States, 98104
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ADX-2191 (intravitreal methotrexate 0.8%); ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.	Drug: ADX-2191 (intravitreal methotrexate 0.8%); ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Active Comparator: Standard surgical care procedure; Standard procedure performed.	Other: Standard surgical care procedure; Standard surgical care performed upon completion of pars plana vitrectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Subjects With Recurrent Retinal Detachment	Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy	Efficacy assessment period (Week 1 to Week 24)
Best-corrected Visual Acuity	Change from baseline of best-corrected visual acuity using an early treatment diabetic retinopathy study (ETDRS) chart. The ETDRS chart contains seventy letters and the visual acuity letter score is equal to the total number of letters read correctly (0 = worst outcome, 70 = best outcome).	Efficacy assessment period (Week 1 to Week 24)
Macular Epiretinal Membrane	Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye	Week 24
Intraocular Pressure Less Than 5 mmHg for Study Eye	Number of subjects with intraocular pressure less than 5 mmHg for study eye	Week 24
Central Macular Subfield Thickness	Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye	Week 24

Collaborators and Investigators

• Sponsor: Aldeyra Therapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 15, 2019
• Primary Completion (Actual): June 14, 2022
• Study Completion (Actual): June 14, 2022

Study Registration Dates

• First Submitted: October 21, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): July 9, 2025
• Last Update Submitted That Met QC Criteria: July 7, 2025
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: ADX-2191; recurrent retinal detachment; open globe injury
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Diseases; Vitreoretinopathy, Proliferative; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Reproductive Control Agents; Antimetabolites, Antineoplastic; Antimetabolites; Dermatologic Agents; Folic Acid Antagonists; Nucleic Acid Synthesis Inhibitors; Methotrexate
• Other Study ID Numbers: ADX-2191-PVR-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No