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

May 31, 2023 updated by: Aldeyra Therapeutics, Inc.

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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

106

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame
Recurrent retinal detachment
Time Frame: Efficacy assessment period (Week 1 to Week 24)
Efficacy assessment period (Week 1 to Week 24)

Secondary Outcome Measures

Outcome Measure
Time Frame
Best-corrected visual acuity (BCVA) change from baseline
Time Frame: Efficacy assessment period (Week 1 to Week 24)
Efficacy assessment period (Week 1 to Week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aldeyra Therapeutics, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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 (Estimated)

June 2, 2023

Last Update Submitted That Met QC Criteria

May 31, 2023

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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