Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

STUDY OVERVIEW

This study by AbbVie aims to evaluate the safety and effectiveness of the XEN45 glaucoma gel stent implanted using the ab externo approach in approximately 65 participants aged 45 years or older with open-angle glaucoma at 22 sites in the United States. Participants will receive the stent on Day 1 and be followed for 12 months, with regular hospital or clinic visits to monitor adverse events and intraocular pressure through medical assessments and eye examinations.

STUDY GOALS

The goal of this study is to evaluate the safety and effectiveness of the XEN45 glaucoma gel stent implanted using the ab externo approach in participants with open-angle glaucoma.

LOCATION

El Paso, Texas: El Paso Eye Surgeons P.A.

INCLUSION CRITERIA

  • Diagnosis of open-angle glaucoma in the study eye, uncontrolled by medical therapy.

  • Study eye must meet at least one of the following:

    • Failed one or more incisional glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (minimum 15 subjects).

    • Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy).

    • Have neovascular glaucoma.

    • Have other conditions (e.g., conjunctival scarring, uveitis) making conventional surgery like trabeculectomy more likely to fail.

  • Note: Up to 10 participants can have only open-angle glaucoma uncontrolled by medical therapy (non-refractory glaucoma).

exclusion criteria

  • Lack of healthy, mobile conjunctiva in the target area.

  • Excessive intraoperative bleeding impairing visualization.

  • Anatomy or findings in the study eye that limit visualization of the anterior chamber, angle, or target conjunctiva.

  • Any surgical complication impeding proper placement of the Gel Stent.

For more information, visit ClinicalTrials.gov.