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

Study Identifier
1924-703-007
CT.gov Identifier
NCT05411198
EudraCT Identifier
Not available
EUCTIS ID
Not available
For general inquiries, please contact

844-663-3742 or [email protected]

Study Complete

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:
    * 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.

    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 externo approach. Adverse events and intraocular pressure will be assessed.

    XEN45 is an approved device for the treatment of glaucoma implanted using the ab interno approach (inside the eye). XEN45 implanted using the ab externo approach (outside the eye) is being studied in this study. Approximately 65 participants aged 45 years or older with open-angle glaucoma will be enrolled in this study at approximately 22 sites in the United States.

    All participants will receive XEN45 implanted using 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
    Vold Vision /ID# 245285
    Fayetteville, Arkansas, United States, 72704
    Status
    Not applicable
    Location
    UCLA Doheny Eye Center /ID# 227587
    Pasadena, California, United States, 91105
    Status
    Not applicable
    Location
    Ventura Ophthalmology /ID# 227585
    Ventura, California, United States, 93003
    Status
    Not applicable
    Location
    East Coast Institute for Research /ID# 255508
    Jacksonville, Florida, United States, 32256-9680
    Status
    Not applicable
    Location
    Center for Sight - Sarasota /ID# 227577
    Sarasota, Florida, United States, 34239
    Status
    Not applicable
    Location
    New Vision Eye Center /ID# 261053
    Vero Beach, Florida, United States, 32960-6551
    Status
    Not applicable
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