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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

AbbVie · NCT06822738

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 45+ · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
130
US sites recruiting
25
Study start
February 11, 2025
Record last updated
October 9, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: XEN63 Glaucoma Treatment System

Conditions: Primary Open Angle Glaucoma

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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 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.

Recruiting US locations

Study contacts (from the official record)

  • ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com
A Study to Assess Adverse Events and Effectiveness of Gel Stent… (NCT06822738) | Bored Studies