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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Raymond Iezzi, M.D.

Open for enrollment

Contact information:

Raymond Iezzi M.D.

(507) 284-4152

Iezzi.Raymond@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20492860

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