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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Proliferative Vitreoretinopathy

Intervention / Treatment
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* Drug: ADX-2191 (intravitreal methotrexate 0.8%)
* Other: Standard surgical care procedure


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is 18 years or older of any gender or race Subject is undergoing pars plana vitrectomy due to recurrent retinal detachment due to proliferative vitreoretionapthy or open globe injury Subject is willing and able to provide written informed consent, comply with clinical trial procedures, and return for all clinical trial visits Subjects of childbearing potential must agree to use two forms of birth control for the duration of the clinical trial Exclusion Criteria: History of severe non-proliferative or proliferative diabetic retinopathy Other planned eye surgery during the course of the trial Participation in a clinical trial with an investigational medicinal product or investigational device within 90 days of subject enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ADX-2191 (intravitreal methotrexate 0.8%)<br>ADX-2191 (intravitreal methotrexate 0.8%) administered over 16 weeks. | Drug: ADX-2191 (intravitreal methotrexate 0.8%)<br>* ADX-2191 (intravitreal methotrexate 0.8%) injected 13 times over 16 weeks upon completion of pars plana vitrectomy<br>|
| Active Comparator: Standard surgical care procedure<br>Standard procedure performed. | Other: Standard surgical care procedure<br>* Standard surgical care performed upon completion of pars plana vitrectomy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrent retinal detachment |  | Efficacy assessment period (Week 1 to Week 24) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Best-corrected visual acuity (BCVA) change from baseline |  | Efficacy assessment period (Week 1 to Week 24) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADX-2191, recurrent retinal detachment, open globe injury