A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

Recruiting now · Phase 3

Conditions studied: Primary 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 interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed. XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States. Participants will receive XEN63 implanted using either the ab interno approach or 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

NCT06822738

Run by

AbbVie

People needed

130

Starts

2025-02-11

Expected to finish

2028-11-01

Last updated by the study team

2026-07-20

Who can join

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

You may qualify if…

• Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)
• That meets the following refractory glaucoma criteria of eyes diagnosed with glaucoma uncontrolled by maximal medical therapy (four or more classes of intraocular pressure (IOP)-lowering medications, or fewer in cases where it has been documented that certain medication classes cannot be tolerated or are contraindicated), and failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery, tube shunt)
• Uncontrolled by medical therapy (to meet out-of-US [OUS] requirements) with participants who only have glaucoma uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion b (and not a) will be enrolled in each cohort.

You may not qualify if…

• History of angle-closure glaucoma where the angle has not been surgically opened in the SE.
• History of secondary open-angle glaucoma (e.g., neovascular, pigmentary, pseudoexfoliative, uveitic, angle recession/traumatic glaucoma, etc.) in the SE.
• Active inflammation (e.g., blepharitis, conjunctivitis, keratitis, uveitis) in the SE.

Where it is running

• The Eye Centers of Racine and Kenosha /ID# 271266 — Kenosha, Wisconsin, United States (enrolling)
• LA Glaucoma Group /ID# 268444 — Culver City, California, United States (enrolling)
• North Bay Eye Associates /ID# 277071 — Petaluma, California, United States (enrolling)
• University Of Colorado - Anschutz Medical Campus /ID# 269947 — Aurora, Colorado, United States (enrolling)
• Colorado Eye Institute /ID# 277072 — Colorado Springs, Colorado, United States (enrolling)
• Berkeley Eye Center - Houston Greenway Plaza /ID# 277078 — Houston, Texas, United States (enrolling)
• University of Virginia /ID# 277487 — Charlottesville, Virginia, United States (enrolling)
• Arizona Advanced Eye Research Institute /ID# 268363 — Glendale, Arizona, United States (enrolling)
• Brandon Eye Associates - Brandon /ID# 277074 — Brandon, Florida, United States (enrolling)
• East Coast Institute for Research /ID# 280411 — Jacksonville, Florida, United States (enrolling)
• New Vision Eye Center /ID# 269955 — Vero Beach, Florida, United States (enrolling)
• Coastal Research Associates - Roswell /ID# 268458 — Roswell, Georgia, United States (enrolling)
• Illinois Eye Center - Peoria Location /ID# 277127 — Peoria, Illinois, United States (enrolling)
• Tulane Center for Clinical Research /ID# 277486 — New Orleans, Louisiana, United States (enrolling)
• Fraser Eye Care Center /ID# 281837 — Fraser, Michigan, United States (enrolling)
• Minnesota Eye Consultants - Minneapolis /ID# 272445 — Minneapolis, Minnesota, United States (enrolling)
• Vance Thompson Vision - Omaha /ID# 271599 — Omaha, Nebraska, United States (enrolling)
• Cincinnati Eye Institute /ID# 279773 — Cincinnati, Ohio, United States (enrolling)
• Oklahoma Eye Surgeons /ID# 269174 — Oklahoma City, Oklahoma, United States (enrolling)
• Ophthalmic Partners of PA /ID# 276059 — Bala-Cynwyd, Pennsylvania, United States (enrolling)
• Wills Eye Hospital /ID# 268569 — Philadelphia, Pennsylvania, United States (enrolling)
• Glaucoma Associates Of Texas /ID# 268745 — Dallas, Texas, United States (enrolling)
• UT Southwestern Medical Center /ID# 268571 — Dallas, Texas, United States (enrolling)
• El Paso Eye Surgeons /ID# 268356 — El Paso, Texas, United States (enrolling)
• Eye Center of Northern Colorado /ID# 281798 — Fort Collins, Colorado, United States

Full record on ClinicalTrials.gov

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