Status:
COMPLETED
The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
Lead Sponsor:
Aldeyra Therapeutics, Inc.
Conditions:
Proliferative Vitreoretinopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 v...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 15 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 14 2022
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT04136366
Start Date
November 15 2019
End Date
June 14 2022
Last Update
July 9 2025
Active Locations (23)
Enter a location and click search to find clinical trials sorted by distance.
1
Retinal Consultants of Arizona
Phoenix, Arizona, United States, 85053
2
University of California Los Angeles
Los Angeles, California, United States, 90095
3
Florida Retina Institute
Orlando, Florida, United States, 32806
4
Bascom Palmer Eye Institute
Palm Beach Gardens, Florida, United States, 33418