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NCT04136366 · ClinicalTrials.gov registry record · Phase 3
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
A Phase 3 study, sponsored by Aldeyra Therapeutics.
- Completed
- Registry status
- Phase 3
- Development phase
- 106
- Enrollment target
NCT04136366: Completed Phase 3 study, sponsored by Aldeyra Therapeutics.
NCT04136366 is a Phase 3 study that has completed, run by Aldeyra Therapeutics. The registered enrollment target is 106 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04136366, a Phase 3 study, has completed, sponsored by Aldeyra Therapeutics.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 106 participants
- Enrollment target
Study 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.
Primary Outcome
Percentage of subjects with recurrent retinal detachments requiring reoperation compared to historical rates
Interventions
- DRUG ADX-2191 (intravitreal methotrexate 0.8%)
- OTHER Standard surgical care procedure
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 106 participants |
| Start Date | 2019-11-15 |
| Est. Completion | 2022-06-14 |
| Phase | Phase 3 |
What the finished NCT04136366 record still lists
NCT04136366 is an interventional study that assigns participants to a tested intervention. The registered 106 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (86% lower).
The record links to 0 conditions, and to 2 interventions - of which ADX-2191 (intravitreal methotrexate 0.8%) is the first listed.
NCT04136366 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04136366 about?
NCT04136366 is a clinical study titled "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.
What is the current status of trial NCT04136366?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 106 participants. The study started on 2019-11-15. Estimated completion is 2022-06-14.
What interventions are being tested in trial NCT04136366?
The interventions under investigation include: ADX-2191 (intravitreal methotrexate 0.8%) (DRUG), Standard surgical care procedure (OTHER).
Who is sponsoring clinical trial NCT04136366?
This trial is sponsored by Aldeyra Therapeutics, which has 26 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04136366's enrollment target sits among peer trials
106 1666th of 2000 higher than 331 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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