At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 106 enrolled
Drug / intervention
ADX-2191 (intravitreal methotrexate 0.8%) +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating ADX-2191 (intravitreal methotrexate 0.8%) and Standard surgical care procedure for Proliferative Vitreoretinopathy. Completed, enrolled 106 participants across 23 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProliferative Vitreoretinopathy
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
2020202120222023202420252026
First PostedOct 2019
Enrollment StartNov 2019
Primary CompletionJun 2022
TodayJul 2026
First PostedOct 23, 2019
Enrollment StartNov 15, 2019
Primary CompletionJun 14, 2022
TodayJul 2, 2026
Enrollment to primary: 2.6 yearsPosted 6.7 years ago
Interventions
ADX-2191 (intravitreal methotrexate 0.8%)drug
ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy
Standard surgical care procedureother
Standard surgical care performed upon completion of pars plana vitrectomy