Conditions: Proliferative Vitreoretinopathy
Keywords: ADX-2191 recurrent retinal detachment open globe injury
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 106
Healthy volunteers: no

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:

Arms:
arm 1: ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. arm 2: Standard procedure performed.

Interventions: intervention 1: ADX-2191 (intravitreal methotrexate 0.8%) intervention 2: Standard surgical care procedure
Intervention descriptions: intervention 1: ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy intervention 2: Standard surgical care performed upon completion of pars plana vitrectomy

Protocol document:
Prot_SAP_000.pdf: