CompletedPhase 3

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

United States106 participantsStarted 2019-11-15

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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 vitreoretinopathy 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

What they're measuring

Recurrent Retinal Detachment Compared to Historical Rates

Timeframe: Efficacy assessment period (Week 1 to Week 24)

Trial details

NCT IDNCT04136366

SponsorAldeyra Therapeutics, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-06-14

Results submitted2025-06-17

View on ClinicalTrials.gov More Proliferative Vitreoretinopathy trials