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
NCT ID: NCT06822738
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
130 participants
INTERVENTIONAL
2025-02-11
2028-11-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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NA
PARALLEL
TREATMENT
SINGLE
Study Groups
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XEN63 Ab Externo
Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
XEN63 Glaucoma Treatment System
Gel Stent
XEN63 Ab Interno
Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
XEN63 Glaucoma Treatment System
Gel Stent
Interventions
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XEN63 Glaucoma Treatment System
Gel Stent
Eligibility Criteria
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Inclusion Criteria
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 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.
45 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, United States
LA Glaucoma Group /ID# 268444
Culver City, California, United States
North Bay Eye Associates /ID# 277071
Petaluma, California, United States
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, United States
Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida, United States
New Vision Eye Center /ID# 269955
Vero Beach, Florida, United States
Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia, United States
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451
Overland Park, Kansas, United States
Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota, United States
Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska, United States
Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma, United States
Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania, United States
Wills Eye Hospital Glaucoma Dept /ID# 268569
Philadelphia, Pennsylvania, United States
Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas, United States
UT Southwestern Medical Center /ID# 268571
Dallas, Texas, United States
El Paso Eye Surgeons /ID# 268356
El Paso, Texas, United States
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119
Roanoke, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Site Coordinator
Role: primary
Related Links
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Other Identifiers
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M22-087
Identifier Type: -
Identifier Source: org_study_id