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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Open-Angle Glaucoma
Intervention / Treatment

-

Contacts and Locations

Fayetteville

Vold Vision /ID# 245285, Fayetteville, Arkansas, United States, 72704

Pasadena

UCLA Doheny Eye Center /ID# 227587, Pasadena, California, United States, 91105

Ventura

Ventura Ophthalmology /ID# 227585, Ventura, California, United States, 93003

Jacksonville

East Coast Institute for Research /ID# 255508, Jacksonville, Florida, United States, 32256-9680

Sarasota

Center for Sight - Sarasota /ID# 227577, Sarasota, Florida, United States, 34239

Vero Beach

New Vision Eye Center /ID# 261053, Vero Beach, Florida, United States, 32960-6551

Atlanta

Georgia Eye Partners /ID# 245203, Atlanta, Georgia, United States, 30342

Overland Park

Stiles Eyecare Excellence /ID# 227576, Overland Park, Kansas, United States, 66213

Bethesda

Johns Hopkins /ID# 245355, Bethesda, Maryland, United States, 20817

Alexandria

Vance Thompson Vision /ID# 261125, Alexandria, Minnesota, United States, 56308-3408

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Glaucoma in the study eye.
  • 1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
  • 2. Study eye that meet at least one of the following criteria:
  • * Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
  • * Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
  • * Have neovascular glaucoma
  • * Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).
  • * A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area.
  • * Excessive intraoperative bleeding, such that visualization in the study eye is impaired.
  • * Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
  • * Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.

Ages Eligible for Study

45 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

ABBVIE INC., STUDY_DIRECTOR, AbbVie

Study Record Dates

2025-08-15