Study to Assess Change in Disease Activity and Adverse Events of Ab Externo Approach for Glaucoma Gel Stent (XEN45) Implantation In Participants Aged 45 Years or Older With Open-Angle Glaucoma

Launched by ABBVIE · Jun 6, 2022

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ClinConnect Summary

This clinical trial is studying a new way to treat open-angle glaucoma, a condition that can lead to vision loss if not properly managed. Researchers are looking at the safety and effectiveness of a device called the XEN45 gel stent when it is implanted from outside the eye, which is known as the "ab externo" approach. The trial will involve about 65 participants aged 45 and older who have glaucoma that hasn't responded well to other treatments. To qualify, participants should have open-angle glaucoma in one eye that has not been controlled with medication, and they may have previously tried other surgical options without success.

If you join this study, you will have the XEN45 gel stent implanted on the first day, and then you will be monitored for 12 months with regular visits to a hospital or clinic. During these visits, doctors will check how well the stent is working and whether there are any side effects. This study aims to provide important information about this new treatment method, which could help improve care for people with glaucoma.

Gender

ALL

Eligibility 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.