Assessing the safety and effectiveness of a glaucoma gel stent implantation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Arizona Advanced Eye Research Institute /ID# 268363
  Glendale, Arizona, United States Recruiting
• LA Glaucoma Group /ID# 268444
  Culver City, California, United States Recruiting
• North Bay Eye Associates /ID# 277071
  Petaluma, California, United States Recruiting
• University Of Colorado - Anschutz Medical Campus /ID# 269947
  Aurora, Colorado, United States Recruiting
• Colorado Eye Institute /ID# 277072
  Colorado Springs, Colorado, United States Recruiting
• Brandon Eye Associates - Brandon /ID# 277074
  Brandon, Florida, United States Recruiting

Study contacts

• Study coordinator: Abbvie Call Center
• Email: abbvieclinicaltrials@abbvie.com
• Phone: 844-663-3742

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.