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
A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma
- Primary Open Angle Glaucoma
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- AbbVie
- Enrolment target
- 130
- Started
- 11 February 2025
- Main results due
- November 2028
- Study sites
- 29
- Registry updated
- 28 September 2026
Can you take part?
- Aged 45 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
Inclusion Criteria:
* Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)
1. 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)
2. 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.
Exclusion Criteria:
* 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.What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(29)
Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, United States
Recruiting
LA Glaucoma Group /ID# 268444
Culver City, California, United States
Recruiting
North Bay Eye Associates /ID# 277071
Petaluma, California, United States
Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, United States
Recruiting
Colorado Eye Institute /ID# 277072
Colorado Springs, Colorado, United States
Recruiting
Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida, United States
Recruiting
East Coast Institute for Research /ID# 280411
Jacksonville, Florida, United States
Recruiting
New Vision Eye Center /ID# 269955
Vero Beach, Florida, United States
Completed
Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia, United States
Recruiting
Illinois Eye Center - Peoria Location /ID# 277127
Peoria, Illinois, United States
Recruiting
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
Overland Park, Kansas, United States
Completed
Tulane University School of Medicine /ID# 277486
New Orleans, Louisiana, United States
Recruiting
Advanced Glaucoma Specialists /ID# 281858
Reading, Massachusetts, United States
Recruiting
Fraser Eye Care Center /ID# 281837
Fraser, Michigan, United States
Recruiting
Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota, United States
Recruiting
Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska, United States
Recruiting
NYC Glaucoma /ID# 283103
New York, New York, United States
Recruiting
Cincinnati Eye Institute /ID# 279773
Cincinnati, Ohio, United States
Recruiting
Cleveland Clinic - Cleveland /ID# 277070
Cleveland, Ohio, United States
Recruiting
Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma, United States
Recruiting
Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania, United States
Recruiting
Wills Eye Hospital /ID# 268569
Philadelphia, Pennsylvania, United States
Recruiting
Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas, United States
Recruiting
University of Texas - Southwestern Medical Center /ID# 268571
Dallas, Texas, United States
Recruiting
El Paso Eye Surgeons /ID# 268356
El Paso, Texas, United States
Recruiting
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078
Houston, Texas, United States
Recruiting
University of Virginia /ID# 277487
Charlottesville, Virginia, United States
Recruiting
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119
Roanoke, Virginia, United States
Completed
The Eye Centers of Racine and Kenosha /ID# 271266
Kenosha, Wisconsin, United States
Recruiting
Showing 29 of 29 sites. 26 of the 29 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06822738. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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