Phase 3
N=106
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Proliferative Vitreoretinopathy
Bottom Line
View on ClinicalTrials.gov: NCT04136366 ↗Enrolled (actual)
106
Serious AEs
0.9%
Results posted
Jul 2025
Primary outcome: Primary: Recurrent Retinal Detachment Compared to Historical Rates — 18.8; 20.6 percentage of subjects
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- ADX-2191 (intravitreal methotrexate 0.8%) (Drug); Standard surgical care procedure (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Aldeyra Therapeutics, Inc.
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Recurrent Retinal Detachment Compared to Historical Rates |
18.8; 20.6 | — |
| SECONDARY Number of Subjects With Recurrent Retinal Detachment |
12; 7 | — |
| SECONDARY Best-corrected Visual Acuity |
16.9; 22.5 | — |
| SECONDARY Macular Epiretinal Membrane |
18; 12 | — |
| SECONDARY Intraocular Pressure Less Than 5 mmHg for Study Eye |
2; 4 | — |
| SECONDARY Central Macular Subfield Thickness |
384.4; 473.7 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04136366). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.