NCT04136366

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

The GUARD Trial - Part 1: A Phase 3 Clinical Trial of Repeated Intravitreal Injections of ADX-2191 Versus Standard-of-Care for Prevention of Proliferative Vitreoretinopathy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: Aldeyra Therapeutics, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Proliferative Vitreoretinopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2019-11-15
• Primary completion: 2022-06-14
• Completion: 2022-06-14
• First posted: 2019-10-23
• Last updated: 2025-07-09
• Results posted: 2025-07-09

Locations

23 sites across 1 country: United States

Regulatory

• FDA-regulated drug study