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

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ClinicalTrials.gov Identifier: NCT04136366
Recruitment Status : Recruiting
First Posted : October 23, 2019
Last Update Posted : January 26, 2021
Sponsor:
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) ]


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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

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


Contacts
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Contact: Bill Cavanagh 781-257-3063 bcavanagh@aldeyra.com

Locations
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Sponsors and Collaborators
Aldeyra Therapeutics, Inc.
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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: January 26, 2021
Last Verified: January 2021

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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