Skip to main content
OpenTrials
Completed

NCT Number: NCT04136366

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Proliferative Vitreoretinopathy Eye Diseases Retinal Detachment Retinal Diseases Vitreoretinopathy, Proliferative

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Retinal Consultants of Arizona, Phoenix, Arizona, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ADX-2191 (intravitreal methotrexate 0.8%)

Drug

ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy

Standard surgical care procedure

Other

Standard surgical care performed upon completion of pars plana vitrectomy

Primary outcomes

  1. Recurrent Retinal Detachment Compared to Historical Rates

    Time frame: Efficacy assessment period (Week 1 to Week 24)

    Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates

Secondary outcomes

  1. Number of Subjects With Recurrent Retinal Detachment

    Time frame: Efficacy assessment period (Week 1 to Week 24)

    Number of subjects with recurrent retinal detachment due to proliferative vitreoretinopathy

  2. Best-corrected Visual Acuity

    Time frame: Efficacy assessment period (Week 1 to Week 24)

    Change from baseline of best-corrected visual acuity using an early treatment diabetic retinopathy study (ETDRS) chart. The ETDRS chart contains seventy letters and the visual acuity letter score is equal to the total number of letters read correctly (0 = worst outcome, 70 = best outcome).

  3. Macular Epiretinal Membrane

    Time frame: Week 24

    Number of subjects with macular epiretinal membrane assessed by spectral domain optical coherence tomography for study eye

  4. Intraocular Pressure Less Than 5 mmHg for Study Eye

    Time frame: Week 24

    Number of subjects with intraocular pressure less than 5 mmHg for study eye

  5. Central Macular Subfield Thickness

    Time frame: Week 24

    Number of subjects with central macular subfield thickness assessed by spectral domain optical coherence tomography for study eye

Sponsors and collaborators

Lead sponsor

Aldeyra Therapeutics, Inc.

Industry

Registry information

Official study 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 Proliferative Vitreoretinopathy

Important dates

Study start
2019
Primary completion
2022
Study completion
2022
First posted
Oct 23, 2019
Registry last updated
Jul 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.