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

Phase 3

Completed

• Conditions: Proliferative Vitreoretinopathy
• Interventions: Other: Standard surgical care procedure; Drug: ADX-2191 (intravitreal methotrexate 0.8%)

• Registration Number: NCT04136366
• Lead Sponsor: Aldeyra Therapeutics, Inc.

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 vitreoretinopathy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-21
• Study First Submitted QC: 2019-10-21
• Study First Posted: 2019-10-23
• Study Start: 2019-11-15
• Primary Completion: 2022-06-14
• Study Completion: 2022-06-14
• Status Verified: 2022-10
• Disposition First Submitted: 2023-05-31
• Last Update Submitted: 2023-05-31
• Disposition First Posted: 2023-06-02
• Last Update Posted: 2023-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard surgical care procedure	Standard surgical care procedure	Standard procedure performed.
ADX-2191 (intravitreal methotrexate 0.8%)	ADX-2191 (intravitreal methotrexate 0.8%)	ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.

Primary Outcome Measures

Name	Time	Method
Recurrent retinal detachment	Efficacy assessment period (Week 1 to Week 24)

Secondary Outcome Measures

Name	Time	Method
Best-corrected visual acuity (BCVA) change from baseline	Efficacy assessment period (Week 1 to Week 24)

Trial Locations

Locations (23)

Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States

University of Iowa; 🇺🇸 Iowa City, Iowa, United States

Associated Retinal Consultants; 🇺🇸 Royal Oak, Michigan, United States

Long Island VitreoRetinal Consultants; 🇺🇸 Forest Hills, New York, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

The Retina Institute; 🇺🇸 Saint Louis, Missouri, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

Massachusetts Eye and Ear; 🇺🇸 Boston, Massachusetts, United States

Florida Retina Institute; 🇺🇸 Orlando, Florida, United States

Bascom Palmer Eye Institute; 🇺🇸 Palm Beach Gardens, Florida, United States

University of California Los Angeles; 🇺🇸 Los Angeles, California, United States

Emory Eye Center; 🇺🇸 Atlanta, Georgia, United States

New England Retina Consultants; 🇺🇸 Springfield, Massachusetts, United States

Retina Consultants of Houston; 🇺🇸 Houston, Texas, United States

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Vitreo-Retinal Surgery; 🇺🇸 Minneapolis, Minnesota, United States

Duke Health Center; 🇺🇸 Durham, North Carolina, United States

Kresge Eye Institute; 🇺🇸 Detroit, Michigan, United States

University of Washington; 🇺🇸 Seattle, Washington, United States

Illinois Retina Associates; 🇺🇸 Joliet, Illinois, United States

Mayo Clinic Ophthalmology; 🇺🇸 Rochester, Minnesota, United States

OHSU Casey Eye Institute; 🇺🇸 Portland, Oregon, United States