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Trial record 1 of 1 for:    guard, methotrexate, aldeyra
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The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04136366
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : July 7, 2020
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Proliferative Vitreoretinopathy Drug: ADX-2191 (intravitreal methotrexate 0.8%) Other: Standard surgical care procedure Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: 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
Actual Study Start Date : November 15, 2019
Estimated Primary Completion Date : December 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Recurrent retinal detachment [ Time Frame: Efficacy assessment period (Week 1 to Week 24) ]

Secondary Outcome Measures :
  1. Best-corrected visual acuity (BCVA) change from baseline [ Time Frame: Efficacy assessment period (Week 1 to Week 24) ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04136366

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Contact: Bill Cavanagh 781-257-3063

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United States, Arizona
Retinal Consultants of Arizona Recruiting
Phoenix, Arizona, United States, 85053
Contact: Derek Y. Kunimoto, MD         
United States, California
University of California Los Angeles Recruiting
Los Angeles, California, United States, 90095
Contact: Tara McCannel, MD    310-206-7484      
United States, Florida
Florida Retina Institute Recruiting
Orlando, Florida, United States, 32806
Contact: S.K. Steven Houston III, MD         
United States, Illinois
Illinois Retina Associates Recruiting
Joliet, Illinois, United States, 60435
Contact: John Pollack, MD         
United States, Massachusetts
Tufts Medical Center Recruiting
Boston, Massachusetts, United States, 02111
Contact: Michelle Liang, MD    617-636-5000      
Ophthalmic Consultants of Boston Recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeffrey S. Heier, MD    800-635-0489      
New England Retina Consultants Recruiting
Springfield, Massachusetts, United States, 01107
Contact: David Lally, MD         
United States, Michigan
Associated Retinal Consultants Recruiting
Royal Oak, Michigan, United States, 48073
Contact: Tamer Mahmoud, MD         
United States, Minnesota
Vitreo-Retinal Surgery Recruiting
Minneapolis, Minnesota, United States, 55432
Contact: Robert Mittra, MD    952-929-1311      
Contact: Neal Oestreich    952-259-6262      
Mayo Clinic Ophthalmology Recruiting
Rochester, Minnesota, United States, 55905
Contact: Raymond Lezzi Jr., MD    507-284-2744      
United States, Missouri
The Retina Institute Recruiting
Saint Louis, Missouri, United States, 63128
Contact: Kevin Blinder, MD    314-367-1181      
Contact: Pam Bilyeu    314-367-1181      
United States, New York
Long Island VitreoRetinal Consultants Recruiting
Forest Hills, New York, United States, 11375
Contact: Juan M. Romero, MD    718-793-6430      
United States, North Carolina
Duke Health Center Recruiting
Durham, North Carolina, United States, 27705
Contact: Lejla Vajzovic, MD    919-681-3937      
United States, Texas
Retina Consultants of Houston Recruiting
Houston, Texas, United States, 77030
Contact: Charles Wykoff, MD         
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98104
Contact: Yewlin Chee, MD    206-744-2020      
Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
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Responsible Party: Aldeyra Therapeutics, Inc. Identifier: NCT04136366    
Other Study ID Numbers: ADX-2191-PVR-001
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: July 7, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Aldeyra Therapeutics, Inc.:
recurrent retinal detachment
open globe injury
Additional relevant MeSH terms:
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Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors