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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 45 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Single Group Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
XEN45 (Glaucoma Gel Stent) 		Participants will receive XEN45 implanted using an ab externo approach on Day 1.
  • Device: XEN45 (Glaucoma Gel Stent)
    Ab externo implant

Recruiting Locations

Ventura Ophthalmology /ID# 227585
Ventura, California 93003

Center for Sight - Sarasota /ID# 227577
Sarasota, Florida 34239

New Vision Eye Center /ID# 261053
Vero Beach, Florida 32960-6551

Stiles Eyecare Excellence /ID# 227576
Overland Park, Kansas 66213

Johns Hopkins /ID# 245355
Bethesda, Maryland 20817

Vance Thompson Vision /ID# 261125
Alexandria, Minnesota 56308-3408

Washington University-School of Medicine /ID# 245452
Saint Louis, Missouri 63110

NYU Langone Medical Center /ID# 227583
New York, New York 10016-6402

Fichte Endl & Elmer Eyecare Ophthalmology PC /ID# 245165
Niagara Falls, New York 14304

Oklahoma Eye Surgeons /ID# 246840
Oklahoma City, Oklahoma 73112

Ophthalmic Partners, PC /ID# 245367
Bala-Cynwyd, Pennsylvania 19004
Contact:
Site Coordinator
484-434-2706

Vance Thompson Vision /ID# 260892
Sioux Falls, South Dakota 57108

University of Texas Southwestern Medical Center /ID# 246848
Dallas, Texas 75390-7208

El Paso Eye Surgeons, P.A. /ID# 227575
El Paso, Texas 79902

Eye associates /ID# 227572
San Antonio, Texas 78229

University of Utah /ID# 245324
Salt Lake City, Utah 84112-5500

Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925
Falls Church, Virginia 22042-3013
Contact:
Site Coordinator
703-534-3900, ext 5

More Details

NCT ID
NCT05411198
Status
Recruiting
Sponsor
AbbVie

Study Contact

ABBVIE CALL CENTER
844-663-3742
abbvieclinicaltrials@abbvie.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.

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Vanderbilt University Medical Center