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

  • STATUS
    Recruiting
  • End date
    Dec 28, 2022
  • participants needed
    120
  • sponsor
    Aldeyra Therapeutics, Inc.
Updated on 28 January 2021
Investigator
Bill Cavanagh, MS
Primary Contact
Massachusetts Eye and Ear (6.3 mi away) Contact
+21 other location

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.

Details
Condition Proliferative vitreoretinopathy
Treatment ADX-2191 (intravitreal methotrexate 0.8%), Standard surgical care procedure
Clinical Study IdentifierNCT04136366
SponsorAldeyra Therapeutics, Inc.
Last Modified on28 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Subject is 18 years or older of any gender or race
Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury
Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits
Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial

Exclusion Criteria

History of severe non-proliferative or proliferative diabetic retinopathy
Other planned eye surgery during the course of the trial
Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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