Clinical trial NCT04136366: The GUARD Trial - Part 1: A Phase 3 Clinical Trial for Prevention of Proliferative Vitreoretinopathy
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Proliferative Vitreoretinopathy
Keywords: ADX-2191
recurrent retinal detachment
open globe injury
Lead sponsor: Aldeyra Therapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-23
Enrollment: 106
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recurrent retinal detachment
timeFrame: Efficacy assessment period (Week 1 to Week 24)
Secondary outcomes:
measure: Best-corrected visual acuity (BCVA) change from baseline
timeFrame: Efficacy assessment period (Week 1 to Week 24)
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Orlando
country: United States
facility: Florida Retina Institute
state: Florida
city: Palm Beach Gardens
country: United States
facility: Bascom Palmer Eye Institute
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center
state: Georgia
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Joliet
country: United States
facility: Illinois Retina Associates
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Boston
country: United States
facility: Massachusetts Eye and Ear
state: Massachusetts
city: Springfield
country: United States
facility: New England Retina Consultants
state: Massachusetts
city: Detroit
country: United States
facility: Kresge Eye Institute
state: Michigan
city: Royal Oak
country: United States
facility: Associated Retinal Consultants
state: Michigan
city: Minneapolis
country: United States
facility: Vitreo-Retinal Surgery
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic Ophthalmology
state: Minnesota
city: Saint Louis
country: United States
facility: The Retina Institute
state: Missouri
city: Forest Hills
country: United States
facility: Long Island VitreoRetinal Consultants
state: New York
city: Durham
country: United States
facility: Duke Health Center
state: North Carolina
city: Portland
country: United States
facility: OHSU Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
References: