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

About

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.

Primary Purpose
Prevention
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

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

Join this Trial

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Study Stats
Protocol No.
19-002011
Category
Ophthalmology
Contact
OMAR LEYVA
Location
  • UCLA Westwood
For Providers
NCT No.
NCT04136366
For detailed technical eligibility, visit ClinicalTrials.gov.