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

Completed · Phase 3

Conditions studied: Open-Angle Glaucoma

In brief

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.

Key facts

Study ID

NCT05411198

Run by

AbbVie

People needed

74

Starts

2022-07-22

Expected to finish

2026-02-04

Last updated by the study team

2026-02-27

Who can join

Age: 45 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Glaucoma in the study eye.
• Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
• 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).
• Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

You may not qualify if…

• 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.

Where it is running

• Vold Vision /ID# 245285 — Fayetteville, Arkansas, United States
• UCLA Doheny Eye Center /ID# 227587 — Pasadena, California, United States
• Ventura Ophthalmology /ID# 227585 — Ventura, California, United States
• East Coast Institute for Research /ID# 255508 — Jacksonville, Florida, United States
• Center for Sight - Sarasota /ID# 227577 — Sarasota, Florida, United States
• New Vision Eye Center /ID# 261053 — Vero Beach, Florida, United States
• Georgia Eye Partners /ID# 245203 — Atlanta, Georgia, United States
• Stiles Eyecare Excellence /ID# 227576 — Overland Park, Kansas, United States
• The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355 — Bethesda, Maryland, United States
• Vance Thompson Vision /ID# 261125 — Alexandria, Minnesota, United States
• Washington University-School of Medicine /ID# 245452 — St Louis, Missouri, United States
• NYU Langone Medical Center /ID# 227583 — New York, New York, United States
• Fichte Endl & Elmer Eyecare /ID# 245165 — Niagara Falls, New York, United States
• Oklahoma Eye Surgeons /ID# 246840 — Oklahoma City, Oklahoma, United States
• Ophthalmic Partners, PC /ID# 245367 — Bala-Cynwyd, Pennsylvania, United States
• Kremer Eye Center - King of Prussia /ID# 245573 — King of Prussia, Pennsylvania, United States
• Vance Thompson Vision /ID# 260892 — Sioux Falls, South Dakota, United States
• Glaucoma Associates of Texas /ID# 227580 — Dallas, Texas, United States
• University of Texas Southwestern Medical Center /ID# 246848 — Dallas, Texas, United States
• El Paso Eye Surgeons, P.A. /ID# 227575 — El Paso, Texas, United States
• Eye associates /ID# 227572 — San Antonio, Texas, United States
• University of Utah /ID# 245324 — Salt Lake City, Utah, United States
• Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925 — Falls Church, Virginia, United States
• Eye Surgery Associates /ID# 252207 — East Melbourne, Victoria, Australia
• Melbourne Eye Specialists /ID# 252353 — Fitzroy, Victoria, Australia

Full record on ClinicalTrials.gov

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