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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
NCT06822738 · AbbVie
In plain English
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Official title
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
About this study
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.
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.
Study design
Enrollment target: 130 participants
Allocation: na
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-02-11
Estimated completion: 2028-11
Last updated: 2026-03-20
Interventions
Device: XEN63 Glaucoma Treatment System
Primary outcomes
- • Percentage of Participants With Treatment Response of Achieving ≥ 20% Reduction in Intraocular Pressure (IOP) From Baseline on the Same or Fewer Number of IOP-Lowering Medications Compared to Baseline (Month 12)
- • Number of Participants with Adverse Events (AEs) (Month 12)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (21)
Arizona Advanced Eye Research Institute /ID# 268363Recruiting
Glendale, Arizona, United States
LA Glaucoma Group /ID# 268444Recruiting
Culver City, California, United States
North Bay Eye Associates /ID# 277071Recruiting
Petaluma, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 269947Recruiting
Aurora, Colorado, United States
Colorado Eye Institute /ID# 277072Recruiting
Colorado Springs, Colorado, United States
Brandon Eye Associates - Brandon /ID# 277074Recruiting
Brandon, Florida, United States
New Vision Eye Center /ID# 269955Recruiting
Vero Beach, Florida, United States
Coastal Research Associates - Roswell /ID# 268458Recruiting
Roswell, Georgia, United States
Illinois Eye Center - Peoria Location /ID# 277127Recruiting
Peoria, Illinois, United States
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451Recruiting
Overland Park, Kansas, United States
Minnesota Eye Consultants - Minneapolis /ID# 272445Recruiting
Minneapolis, Minnesota, United States
Vance Thompson Vision - Omaha /ID# 271599Recruiting
Omaha, Nebraska, United States
Oklahoma Eye Surgeons /ID# 269174Recruiting
Oklahoma City, Oklahoma, United States
Ophthalmic Partners of PA /ID# 276059Recruiting
Bala-Cynwyd, Pennsylvania, United States
Wills Eye Hospital Glaucoma Dept /ID# 268569Recruiting
Philadelphia, Pennsylvania, United States
Glaucoma Associates Of Texas /ID# 268745Recruiting
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 268571Recruiting
Dallas, Texas, United States
El Paso Eye Surgeons /ID# 268356Recruiting
El Paso, Texas, United States
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078Recruiting
Houston, Texas, United States
University of Virginia /ID# 277487Recruiting
Charlottesville, Virginia, United States
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119Recruiting
Roanoke, Virginia, United States