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

Launched by ABBVIE · Feb 7, 2025

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ClinConnect Summary

This clinical trial is studying a new treatment option for adults with primary open-angle glaucoma, a condition that can lead to vision loss if not properly managed. The trial is specifically looking at the safety and effectiveness of a gel stent called XEN63, which can be implanted either from inside the eye (ab interno) or from outside the eye (ab externo). The study aims to determine how well this device can help lower eye pressure, which is crucial for managing glaucoma. About 130 participants aged 45 and older are being recruited from various locations around the world.

To be eligible for the trial, participants must have glaucoma that has not responded well to standard treatments, such as medications or previous surgeries. They will be divided into two groups, with one group receiving the gel stent through the inside approach and the other through the outside approach. Each participant will have the stent implanted on the first day of the study and will be monitored for 12 months through regular visits for eye exams and medical checks. This is an important opportunity for those with challenging glaucoma cases to potentially benefit from a new treatment method.

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ALL

Eligibility 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.