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Assessing a new approach for glaucoma treatment in older adults

A Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Ab Externo Implantation of Glaucoma Gel Stent

Phase 3 Interventional AbbVie · NCT05411198

This study is testing a new glaucoma treatment using a special gel stent in older adults to see if it helps manage their condition safely and effectively.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment65 (estimated)
Ages45 Years and up
SexAll
SponsorAbbVie Industry-sponsored
Locations25 sites (Fayetteville, Arkansas and 24 other locations)
Trial IDNCT05411198 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and effectiveness of the XEN45 glaucoma gel stent when implanted using an external approach in participants aged 45 years or older with open-angle glaucoma. Approximately 65 participants will receive the stent and be monitored for 12 months through regular medical assessments and eye examinations. The study aims to determine changes in disease activity and any adverse events associated with this new implantation method. The trial will take place across approximately 22 sites in the United States.

Who should consider this trial

Good fit: Ideal candidates are individuals aged 45 years or older with open-angle glaucoma that is uncontrolled by medical therapy.

Not a fit: Patients with health conditions that preclude them from undergoing the procedure or those with glaucoma that is not open-angle may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and more effective treatment option for patients with open-angle glaucoma.

How similar studies have performed: Other studies have shown success with similar approaches, but this specific method of implantation is being evaluated for the first time.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Glaucoma in the study eye.

  1. Study eye diagnosed with open-angle glaucoma uncontrolled by medical therapy
  2. Study eye that meet at least one of the following criteria:

     * Failed one or more incisional intraocular glaucoma surgeries (e.g., glaucoma filtering surgery or tube shunt) (a minimum of approximately 15 subjects will be enrolled)
     * Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiode therapy)
     * Have neovascular glaucoma
     * Have any other condition (e.g., conjunctival scarring, uveitis) in which a conventional incisional glaucoma surgery like trabeculectomy would be more likely to fail than for a person with uncomplicated primary open-angle glaucoma (OAG).

     Note: To allow for a subgroup of participants who only have OAG uncontrolled by medical therapy (non-refractory glaucoma), a maximum of 10 participants who meet only criterion a (and not b) will be enrolled.

     Exclusion Criteria:
* A lack of healthy conjunctiva showing free mobility (free of scarring or evidence of prior surgery) in the target area.
* Excessive intraoperative bleeding, such that visualization in the study eye is impaired.
* Any anatomy or finding in the study eye that limits the investigator's ability to visualize the anterior chamber, angle, or target area of the conjunctiva.
* Other surgical complication that in the opinion of the investigator could impede proper placement of the Gel Stent.

Where this trial is running

Fayetteville, Arkansas and 24 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 → Find more trials like this →
Conditions Open-Angle GlaucomaGlaucomaOAGXEN45Glaucoma Gel StentXEN45 Glaucoma Treatment System
Last reviewed 2026-06-13 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.