Study to Evaluate Safety and Effectiveness of XEN63 Gel Stent Implanted by Ab Interno or Ab Externo Methods in Adults with Glaucoma

What this Trial Is About

Glaucoma, a leading cause of blindness worldwide, is the focus of this study evaluating the safety and effectiveness of a glaucoma gel stent called XEN63. This device is intended for patients with glaucoma whose intraocular pressure (IOP) remains uncontrolled despite medical or surgical treatments. The trial compares two implantation methods: ab interno (inside the eye) and ab externo (outside the eye), enrolling about 130 participants aged 45 years or older with glaucoma. Participants receive the XEN63 gel stent implanted either by the ab interno or ab externo approach on the first day of the study. They are then monitored regularly over 12 months to assess and compare the outcomes of each implantation method. The study takes place at approximately 32 sites across the United States. Throughout the 12-month follow-up, participants attend scheduled visits at hospitals or clinics where medical assessments and eye examinations evaluate the safety and effectiveness of the gel stent. Researchers measure the percentage of participants achieving at least a 20% reduction in IOP from baseline using the same or fewer IOP-lowering medications. They also track adverse events to monitor safety during the study period.

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