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

Aldeyra Therapeutics

Status and phase: Completed; Phase 3

Conditions: Proliferative Vitreoretinopathy

Treatments: Drug: ADX-2191 (intravitreal methotrexate 0.8%); Other: Standard surgical care procedure

Study type: Interventional

Funder types: Industry

Identifiers

NCT04136366

ADX-2191-PVR-001

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

106 participants in 2 patient groups

ADX-2191 (intravitreal methotrexate 0.8%)

Experimental group

Description:

ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks.

Treatment:

Drug: ADX-2191 (intravitreal methotrexate 0.8%)

Standard surgical care procedure

Active Comparator group

Description:

Standard procedure performed.

Treatment:

Other: Standard surgical care procedure