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

Study Identifier
M22-087
CT.gov Identifier
NCT06822738
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Recruiting
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Study Details

Medical Condition
  • Glaucoma - Open Angle
    • Study Drug
    N/A
    Phase
    Phase 3
    Sex
    Female & Male
    Age
    45+ years
    Inclusion and Exclusion 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.

    Protocol Summary

    Glaucoma is the second most common cause of blindness in the world, second only to cataracts. This study will assess how safe and effective a glaucoma gel stent is when implanted using the ab interno (inside the eye) and ab externo (outside the eye) approach. Adverse events and intraocular pressure will be assessed.

    XEN63 is an investigational device for the treatment of intraocular pressure (IOP) in patients with glaucoma when both medical and conventional surgical treatments have failed (for US approval) and when medical treatments have failed (for outside US \[OUS\] approval). Participants will be placed in one of two groups called study arms. One group will receive the XEN63 gel stent ab interno (inside the eye) and the other group will receive the XEN63 gel stent ab externo (outside the eye). Approximately 130 participants aged 45 years or older with glaucoma will be enrolled in this study at approximately 32 sites in the United States.

    Participants will receive XEN63 implanted using either the ab interno approach or the ab externo approach on Day 1 and will be followed for 12 months.

    Participants will attend regular visits during the study at a hospital or clinic. The safety and effect of the gel stent on your glaucoma will be checked by medical assessments and eye examinations.

    Study Locations

    Location
    Status
    Location
    Arizona Advanced Eye Research Institute /ID# 268363
    Glendale, Arizona, United States, 85306
    Status
    Recruiting
    Location
    LA Glaucoma Group /ID# 268444
    Culver City, California, United States, 90232
    Status
    Recruiting
    Location
    North Bay Eye Associates /ID# 277071
    Petaluma, California, United States, 94954
    Status
    Recruiting
    Location
    University Of Colorado - Anschutz Medical Campus /ID# 269947
    Aurora, Colorado, United States, 80045
    Status
    Recruiting
    Location
    Colorado Eye Institute /ID# 277072
    Colorado Springs, Colorado, United States, 80924
    Status
    Recruiting
    Location
    Eye Center of Northern Colorado /ID# 281798
    Fort Collins, Colorado, United States, 80528
    Status
    Not yet recruiting
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