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

Last updated: November 18, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Glaucoma

Treatment

XEN45 (Glaucoma Gel Stent)

Clinical Study ID

NCT05411198
1924-703-007
  • Ages > 45
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 15subjects will be enrolled)
  • Failed one or more cilioablative procedures (e.g., cryotherapy, cyclodiodetherapy)
  • Have neovascular glaucoma
  • Have any other condition (e.g., conjunctival scarring, uveitis) in which aconventional incisional glaucoma surgery like trabeculectomy would be morelikely to fail than for a person with uncomplicated primary open-angleglaucoma (OAG).Note: To allow for a subgroup of participants who only have OAG uncontrolled bymedical therapy (non-refractory glaucoma), a maximum of 10 participants whomeet only criterion a (and not b) will be enrolled.

Exclusion

Exclusion Criteria:

  • A lack of healthy conjunctiva showing free mobility (free of scarring or evidence ofprior surgery) in the target area.

  • Excessive intraoperative bleeding, such that visualization in the study eye isimpaired.

  • Any anatomy or finding in the study eye that limits the investigator's ability tovisualize the anterior chamber, angle, or target area of the conjunctiva.

  • Other surgical complication that in the opinion of the investigator could impedeproper placement of the Gel Stent.

Study Design

Total Participants: 65
Treatment Group(s): 1
Primary Treatment: XEN45 (Glaucoma Gel Stent)
Phase: 3
Study Start date:
July 22, 2022
Estimated Completion Date:
August 15, 2025

Connect with a study center

  • Eye Surgery Associates /ID# 252207

    East Melbourne, Victoria 3002
    Australia

    Active - Recruiting

  • Melbourne Eye Specialists /ID# 252353

    Fitzroy, Victoria VIC3065
    Australia

    Active - Recruiting

  • Vold Vision /ID# 245285

    Fayetteville, Arkansas 72704
    United States

    Completed

  • UCLA Doheny Eye Center /ID# 227587

    Pasadena, California 91105
    United States

    Completed

  • Ventura Ophthalmology /ID# 227585

    Ventura, California 93003
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Connecticut - Fairfield /ID# 246798

    Fairfield, Connecticut 06824-5318
    United States

    Site Not Available

  • East Coast Institute for Research /ID# 255508

    Jacksonville, Florida 32256-9680
    United States

    Completed

  • Center for Sight - Sarasota /ID# 227577

    Sarasota, Florida 34239
    United States

    Active - Recruiting

  • New Vision Eye Center /ID# 261053

    Vero Beach, Florida 32960-6551
    United States

    Active - Recruiting

  • Georgia Eye Partners /ID# 245203

    Atlanta, Georgia 30342
    United States

    Completed

  • Stiles Eyecare Excellence /ID# 227576

    Overland Park, Kansas 66213
    United States

    Active - Recruiting

  • Johns Hopkins /ID# 245355

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston /ID# 227573

    Boston, Massachusetts 02129
    United States

    Site Not Available

  • University of Michigan, Kellogg Eye Center /ID# 227586

    Ann Arbor, Michigan 48105
    United States

    Site Not Available

  • Vance Thompson Vision /ID# 261125

    Alexandria, Minnesota 56308-3408
    United States

    Active - Recruiting

  • Washington University-School of Medicine /ID# 245452

    Saint Louis, Missouri 63110
    United States

    Active - Recruiting

  • NYU Langone Medical Center /ID# 227583

    New York, New York 10016-6402
    United States

    Active - Recruiting

  • New York University, Langone Health /ID# 227583

    New York, New York 10017
    United States

    Active - Recruiting

  • Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165

    Niagara Falls, New York 14304
    United States

    Active - Recruiting

  • Oklahoma Eye Surgeons /ID# 246840

    Oklahoma City, Oklahoma 73112
    United States

    Active - Recruiting

  • Ophthalmic Partners, PC /ID# 245367

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Active - Recruiting

  • Kremer Eye Center - King of Prussia /ID# 245573

    King Of Prussia, Pennsylvania 19406
    United States

    Completed

  • Vance Thompson Vision /ID# 260892

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • University of Tennessee Health Science Center /ID# 245449

    Memphis, Tennessee 38103-3403
    United States

    Site Not Available

  • Glaucoma Associates of Texas /ID# 227580

    Dallas, Texas 75231
    United States

    Completed

  • University of Texas Southwestern Medical Center /ID# 246848

    Dallas, Texas 75390-7208
    United States

    Active - Recruiting

  • El Paso Eye Surgeons, P.A. /ID# 227575

    El Paso, Texas 79902
    United States

    Active - Recruiting

  • Eye associates /ID# 227572

    San Antonio, Texas 78229
    United States

    Active - Recruiting

  • University of Utah /ID# 245324

    Salt Lake City, Utah 84112-5500
    United States

    Active - Recruiting

  • Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925

    Falls Church, Virginia 22042-3013
    United States

    Active - Recruiting

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