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Assessing the safety and effectiveness of a glaucoma gel stent implantation

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma

PHASE3 · AbbVie · NCT06822738

This study is testing a new gel stent for treating glaucoma to see if it works well and is safe for people over 45 who haven't had success with other treatments.

Quick facts

PhasePHASE3
Study typeInterventional
Enrollment130 (estimated)
Ages45 Years and up
SexAll
SponsorAbbVie (industry)
Locations22 sites (Glendale, Arizona and 21 other locations)
Trial IDNCT06822738 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and effectiveness of the XEN63 gel stent for treating primary open-angle glaucoma using two different implantation techniques: ab interno (inside the eye) and ab externo (outside the eye). Approximately 130 participants aged 45 and older, who have glaucoma uncontrolled by medical therapy or previous surgeries, will be enrolled across 32 sites in North America and Europe. The study will monitor adverse events and changes in intraocular pressure to determine the stent's effectiveness.

Who should consider this trial

Good fit: Ideal candidates are adults aged 45 and older with primary open-angle glaucoma that is uncontrolled by maximal medical therapy or who have failed previous surgical interventions.

Not a fit: Patients with angle-closure glaucoma or secondary open-angle glaucoma may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new treatment option for patients with glaucoma who have not responded to existing therapies.

How similar studies have performed: Other studies have shown promise with similar approaches to glaucoma treatment, but the specific use of the XEN63 gel stent is relatively novel.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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

  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 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.

Where this trial is running

Glendale, Arizona and 21 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Primary Open Angle Glaucoma, AGN-9003

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.