NCT05411198

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

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: AbbVie · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab externo approach. Adverse events and intraocular pressure will be assessed. XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States. All participants will receive XEN45 implanted using the ab externo approach on Day 1 and will be followed for 12 months. Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.

Conditions

• Open-Angle Glaucoma

Interventions

Type	Name	Description
DEVICE	XEN45 (Glaucoma Gel Stent)	Ab externo implant

Timeline

• Start date: 2022-07-22
• Primary completion: 2026-02-04
• Completion: 2026-02-04
• First posted: 2022-06-09
• Last updated: 2026-02-27

Locations

25 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated device study