Status:
RECRUITING
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
Lead Sponsor:
AbbVie
Conditions:
Primary Open Angle Glaucoma
Eligibility:
All Genders
45+ years
Phase:
PHASE3
Brief Summary
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
February 11 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2028
Estimated Enrollment :
130 Patients enrolled
Trial Details
Trial ID
NCT06822738
Start Date
February 11 2025
End Date
November 1 2028
Last Update
February 24 2026
Active Locations (21)
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1
Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona, United States, 85306
2
LA Glaucoma Group /ID# 268444
Culver City, California, United States, 90232
3
North Bay Eye Associates /ID# 277071
Petaluma, California, United States, 94954
4
University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado, United States, 80045