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: February 26, 2026
Sponsor: AbbVie
Overall Status: Completed

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: 74
Treatment Group(s): 1
Primary Treatment: XEN45 (Glaucoma Gel Stent)
Phase: 3
Study Start date:
July 22, 2022
Estimated Completion Date:
February 04, 2026

Connect with a study center

  • Eye Surgery Associates /ID# 252207

    East Melbourne, Victoria 3002
    Australia

    Site Not Available

  • Melbourne Eye Specialists /ID# 252353

    Fitzroy, Victoria VIC3065
    Australia

    Site Not Available

  • Eye Surgery Associates /ID# 252207

    East Melbourne 6952201, Victoria 2145234 3002
    Australia

    Site Not Available

  • Melbourne Eye Specialists /ID# 252353

    Fitzroy 2166584, Victoria 2145234 VIC3065
    Australia

    Site Not Available

  • Vold Vision /ID# 245285

    Fayetteville, Arkansas 72704
    United States

    Site Not Available

  • Vold Vision /ID# 245285

    Fayetteville 4110486, Arkansas 4099753 72704
    United States

    Site Not Available

  • UCLA Doheny Eye Center /ID# 227587

    Pasadena, California 91105
    United States

    Site Not Available

  • Ventura Ophthalmology /ID# 227585

    Ventura, California 93003
    United States

    Site Not Available

  • UCLA Doheny Eye Center /ID# 227587

    Pasadena 5381396, California 5332921 91105
    United States

    Site Not Available

  • Ventura Ophthalmology /ID# 227585

    Ventura 5405878, California 5332921 93003
    United States

    Site Not Available

  • 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

    Site Not Available

  • Center for Sight - Sarasota /ID# 227577

    Sarasota, Florida 34239
    United States

    Site Not Available

  • New Vision Eye Center /ID# 261053

    Vero Beach, Florida 32960-6551
    United States

    Site Not Available

  • East Coast Institute for Research /ID# 255508

    Jacksonville 4160021, Florida 4155751 32256-9680
    United States

    Site Not Available

  • Center for Sight - Sarasota /ID# 227577

    Sarasota 4172131, Florida 4155751 34239
    United States

    Site Not Available

  • New Vision Eye Center /ID# 261053

    Vero Beach 4176409, Florida 4155751 32960-6551
    United States

    Site Not Available

  • Georgia Eye Partners /ID# 245203

    Atlanta, Georgia 30342
    United States

    Completed

  • Omni Eye Services - Atlanta (North) /ID# 247477

    Atlanta, Georgia 30342-1705
    United States

    Site Not Available

  • Georgia Eye Partners /ID# 245203

    Atlanta 4180439, Georgia 4197000 30342
    United States

    Site Not Available

  • Stiles Eyecare Excellence /ID# 227576

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Stiles Eyecare Excellence /ID# 227576

    Overland Park 4276873, Kansas 4273857 66213
    United States

    Site Not Available

  • Johns Hopkins /ID# 245355

    Bethesda, Maryland 20817
    United States

    Active - Recruiting

  • The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355

    Bethesda, Maryland 20817
    United States

    Site Not Available

  • The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355

    Bethesda 4348599, Maryland 4361885 20817
    United States

    Site Not Available

  • 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

    Site Not Available

  • Vance Thompson Vision /ID# 261125

    Alexandria 5016108, Minnesota 5037779 56308-3408
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 245452

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Washington University-School of Medicine /ID# 245452

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • NYU Langone Medical Center /ID# 227583

    New York, New York 10016-6402
    United States

    Site Not Available

  • 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

    Site Not Available

  • NYU Langone Medical Center /ID# 227583

    New York 5128581, New York 5128638 10016-6402
    United States

    Site Not Available

  • Fichte Endl & Elmer Eyecare /ID# 245165

    Niagara Falls 5128723, New York 5128638 14304
    United States

    Site Not Available

  • Oklahoma Eye Surgeons /ID# 246840

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oklahoma Eye Surgeons /ID# 246840

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Ophthalmic Partners, PC /ID# 245367

    Bala-Cynwyd, Pennsylvania 19004
    United States

    Site Not Available

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

    King Of Prussia, Pennsylvania 19406
    United States

    Site Not Available

  • Ophthalmic Partners, PC /ID# 245367

    Bala-Cynwyd 5178892, Pennsylvania 6254927 19004
    United States

    Site Not Available

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

    King of Prussia 5196220, Pennsylvania 6254927 19406
    United States

    Site Not Available

  • Vance Thompson Vision /ID# 260892

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Vance Thompson Vision /ID# 260892

    Sioux Falls 5231851, South Dakota 5769223 57108
    United States

    Site Not Available

  • 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

    Site Not Available

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

    El Paso, Texas 79902
    United States

    Site Not Available

  • Eye associates /ID# 227572

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Glaucoma Associates of Texas /ID# 227580

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • University of Texas Southwestern Medical Center /ID# 246848

    Dallas 4684888, Texas 4736286 75390-7208
    United States

    Site Not Available

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

    El Paso 5520993, Texas 4736286 79902
    United States

    Site Not Available

  • Eye associates /ID# 227572

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • University of Utah /ID# 245324

    Salt Lake City, Utah 84112-5500
    United States

    Site Not Available

  • University of Utah /ID# 245324

    Salt Lake City 5780993, Utah 5549030 84112-5500
    United States

    Site Not Available

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

    Falls Church, Virginia 22042-3013
    United States

    Site Not Available

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

    Falls Church 4758390, Virginia 6254928 22042-3013
    United States

    Site Not Available

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