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Trial record 1 of 1 for:    GUARD + ADX-2191
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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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04136366
Recruitment Status : Completed
First Posted : October 23, 2019
Last Update Posted : June 2, 2023
Sponsor:
Information provided by (Responsible Party):
Aldeyra Therapeutics, Inc.

Study Description
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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

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 106 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
Actual Primary Completion Date : June 14, 2022
Actual Study Completion Date : June 14, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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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) ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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 ClinicalTrials.gov identifier (NCT number): NCT04136366


Locations
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Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
More Information
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Responsible Party: Aldeyra Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04136366    
Other Study ID Numbers: ADX-2191-PVR-001
First Posted: October 23, 2019    Key Record Dates
Last Update Posted: June 2, 2023
Last Verified: October 2022

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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.:
ADX-2191
recurrent retinal detachment
open globe injury
Additional relevant MeSH terms:
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Vitreoretinopathy, Proliferative
Retinal Diseases
Eye Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
 Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors