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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 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.

Condition

Eligibility

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
N/A
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
XEN63 Ab Externo 		Participants will be implanted with XEN63 via ab externo surgical approach in the study eye. Participants will be followed for up to 12 months.
  • Device: XEN63 Glaucoma Treatment System
    Gel Stent
Experimental
XEN63 Ab Interno 		Participants will be implanted with XEN63 via ab interno surgical approach in the study eye. Participants will be followed for up to 12 months.
  • Device: XEN63 Glaucoma Treatment System
    Gel Stent

Recruiting Locations

Arizona Advanced Eye Research Institute /ID# 268363
Glendale, Arizona 85306

LA Glaucoma Group /ID# 268444
Culver City, California 90232

North Bay Eye Associates /ID# 277071
Petaluma, California 94954

University Of Colorado - Anschutz Medical Campus /ID# 269947
Aurora, Colorado 80045

Colorado Eye Institute /ID# 277072
Colorado Springs, Colorado 80924

Brandon Eye Associates - Brandon /ID# 277074
Brandon, Florida 33511

East Coast Institute for Research /ID# 280411
Jacksonville, Florida 32256

New Vision Eye Center /ID# 269955
Vero Beach, Florida 32960

Coastal Research Associates - Roswell /ID# 268458
Roswell, Georgia 30076

Illinois Eye Center - Peoria Location /ID# 277127
Peoria, Illinois 61615

Tulane Center for Clinical Research /ID# 277486
New Orleans, Louisiana 70112-2703

Fraser Eye Care Center /ID# 281837
Fraser, Michigan 48026

Minnesota Eye Consultants - Minneapolis /ID# 272445
Minneapolis, Minnesota 55431

Vance Thompson Vision - Omaha /ID# 271599
Omaha, Nebraska 68137

Cincinnati Eye Institute /ID# 279773
Cincinnati, Ohio 45242

Oklahoma Eye Surgeons /ID# 269174
Oklahoma City, Oklahoma 73112

Ophthalmic Partners of PA /ID# 276059
Bala-Cynwyd, Pennsylvania 19004

Wills Eye Hospital /ID# 268569
Philadelphia, Pennsylvania 19107

Glaucoma Associates Of Texas /ID# 268745
Dallas, Texas 75231

UT Southwestern Medical Center /ID# 268571
Dallas, Texas 75390
Contact:
Site Coordinator
214-645-2014

El Paso Eye Surgeons /ID# 268356
El Paso, Texas 79902

Berkeley Eye Center - Houston Greenway Plaza /ID# 277078
Houston, Texas 77027

University of Virginia /ID# 277487
Charlottesville, Virginia 22908

The Eye Centers of Racine and Kenosha /ID# 271266
Kenosha, Wisconsin 53142

More Details

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.