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Study identifier: NCT06822738 Synced from ClinicalTrials.gov · July 28, 2026
● 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

Condition: Primary Open Angle Glaucoma  ·  Sponsor: AbbVie

PhasePhase 3
Planned participants130
Who can joinAll sexes, 45 Years to no upper limit
Healthy volunteersNo

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.

This description comes directly from the study's public registry record.

Talk to the study team

ABBVIE CALL CENTER  ·  844-663-3742  ·  abbvieclinicaltrials@abbvie.com

Always discuss trial participation with your own doctor first.

Locations (27)

Arizona Advanced Eye Research Institute /ID# 268363Glendale, Arizona, United StatesRecruiting
LA Glaucoma Group /ID# 268444Culver City, California, United StatesRecruiting
North Bay Eye Associates /ID# 277071Petaluma, California, United StatesRecruiting
University Of Colorado - Anschutz Medical Campus /ID# 269947Aurora, Colorado, United StatesRecruiting
Colorado Eye Institute /ID# 277072Colorado Springs, Colorado, United StatesRecruiting
Eye Center of Northern Colorado /ID# 281798Fort Collins, Colorado, United StatesNot Yet Recruiting
Brandon Eye Associates - Brandon /ID# 277074Brandon, Florida, United StatesRecruiting
East Coast Institute for Research /ID# 280411Jacksonville, Florida, United StatesRecruiting
New Vision Eye Center /ID# 269955Vero Beach, Florida, United StatesRecruiting
Coastal Research Associates - Roswell /ID# 268458Roswell, Georgia, United StatesRecruiting
Illinois Eye Center - Peoria Location /ID# 277127Peoria, Illinois, United StatesRecruiting
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451Overland Park, Kansas, United StatesCompleted

+ 15 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06822738