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NCT04136366 Clinical Trial

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

Proliferative Vitreoretinopathy Clinical Trial

Official 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 Proliferaivie Vitreoretinopathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04136366
Other study ID # ADX-2191-PVR-001
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 15, 2019
Est. completion date June 14, 2022

Study information
Verified date October 2022
Source Aldeyra Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date June 14, 2022
Est. primary completion date June 14, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Subject is 18 years or older of any gender or race 2. Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury 3. Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits 4. Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial Exclusion Criteria: 1. History of severe non-proliferative or proliferative diabetic retinopathy 2. Other planned eye surgery during the course of the trial 3. Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ADX-2191 (intravitreal methotrexate 0.8%)
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Other:
• Standard surgical care procedure
Standard surgical care performed upon completion of pars plana vitrectomy

Locations
Country Name City State
United States Emory Eye Center Atlanta Georgia
United States Massachusetts Eye and Ear Boston Massachusetts
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Tufts Medical Center Boston Massachusetts
United States University of Illinois at Chicago Chicago Illinois
United States Kresge Eye Institute Detroit Michigan
United States Duke Health Center Durham North Carolina
United States Long Island VitreoRetinal Consultants Forest Hills New York
United States Retina Consultants of Houston Houston Texas
United States University of Iowa Iowa City Iowa
United States Illinois Retina Associates Joliet Illinois
United States University of California Los Angeles Los Angeles California
United States Vitreo-Retinal Surgery Minneapolis Minnesota
United States Florida Retina Institute Orlando Florida
United States Bascom Palmer Eye Institute Palm Beach Gardens Florida
United States Mid Atlantic Retina Philadelphia Pennsylvania
United States Retinal Consultants of Arizona Phoenix Arizona
United States OHSU Casey Eye Institute Portland Oregon
United States Mayo Clinic Ophthalmology Rochester Minnesota
United States Associated Retinal Consultants Royal Oak Michigan
United States The Retina Institute Saint Louis Missouri
United States University of Washington Seattle Washington
United States New England Retina Consultants Springfield Massachusetts

Sponsors (1)
Lead Sponsor Collaborator
Aldeyra Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Recurrent retinal detachment Efficacy assessment period (Week 1 to Week 24)
Secondary Best-corrected visual acuity (BCVA) change from baseline Efficacy assessment period (Week 1 to Week 24)
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