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A Study of the XEN63 Gel Stent for Glaucoma

This study is looking at how safe and effective a device called the XEN63 Glaucoma Treatment System (a gel stent) is for adults with glaucoma. Glaucoma is a condition that can lead to blindness. The XEN63 gel stent helps lower the pressure inside your eye (intraocular pressure or IOP). Researchers will implant the stent using two different methods: from inside the eye (ab interno) or from outside the eye (ab externo). The study will measure how many participants have a significant drop in eye pressure and how many experience side effects over 12 months. You may be able to join if you are at least 45 years old and have glaucoma that hasn't been controlled by other treatments.

Study design
This is an interventional study planning to enroll 130 participants. Participants will be placed into one of two groups to receive the XEN63 gel stent.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least 12 months after treatment to assess eye pressure and adverse events.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06822738

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

Recruiting
PHASE3Ages 45+InterventionalTreatment
AbbVie
~130 participants
Updated 2026-08-14 on ClinicalTrials.gov
What's tested:XEN63 Glaucoma Treatment System

At a glance

Recruiting sites
25 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
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
Measured over Month 12
+1 more outcome measured

Conditions

Primary Open Angle Glaucoma

Explore related trials

Primary Open Angle Glaucoma

Where it's being run

28 sites across 17 states
Texas4
Colorado3
Florida3
California2
Ohio2
Pennsylvania2
Virginia2
Arizona1

Study leadership

  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

Who to contact

ABBVIE CALL CENTER
[email protected]
844-663-3742
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of glaucoma in the study eye (SE) (meeting criterion a or b)

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.

What this trial measures

  • 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 BaselineMonth 12

    IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.

  • Number of Participants with Adverse Events (AEs)Month 12

    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.