A Study to Assess Adverse Events and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Adult Participants With Glaucoma

Recruitment Status
RECRUITING
(See Contacts and Locations)Verified April 2026 by AbbVie
Sponsor
AbbVie
Information Provided by (Responsible Party)
AbbVie
Clinicaltrials.gov Identifier
NCT06822738
Other Study ID Numbers:
M22-087
First Submitted
February 6, 2025
First Posted
February 11, 2025
Last Update Posted
May 12, 2026
Last Verified
April 2026

ClinicalTrials.gov processed this data on May 2026. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Primary Open Angle Glaucoma
Device: XEN63 Glaucoma Treatment SystemDevice: XEN63 Glaucoma Treatment System

Study Design

Study TypeInterventional
Actual Enrollment130 participants
Design AllocationN/A
Interventional ModelParallel Assignment
MaskingSingle
Primary PurposeTreatment
Official TitleA Prospective, Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Gel Stent (XEN63) Implantation Using Ab Interno and Ab Externo Approaches in Subjects With Glaucoma
Study Start DateFebruary 10, 2025
Actual Primary Completion Date2yrs 5mos from now
Actual Study Completion Date2yrs 5mos from now

Groups and Cohorts

Group/CohortIntervention/Treatment
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
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

Outcome Measures

Primary Outcome Measures
  1. Percentage of Participants With Treatment Response of Achieving ≥ 20% Reduction in Intraocular Pressure (IOP) From Baseline on the Same or Fewer Number of IOP-Lowering Medications Compared to Baseline
    IOP is a measurement of the fluid pressure inside the study eye. Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications.
  2. Number of Participants with Adverse Events (AEs)
    An AE is defined as any untoward medical occurrence in a patient or clinical investigation in which a participant is administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Secondary Outcome Measures
  1. Mean Diurnal IOP
    IOP is a measurement of the fluid pressure inside the eye. The mean diurnal IOP was the average of the IOP values of the study eye at Month 12.
  2. Change From Baseline in Diurnal IOP
    IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
  3. Change from Baseline in Number of Topical IOP-Lowering Medications
    A numerical count by class of drug of topical IOP lowering medications being taken.
  4. Mean Number of Topical IOP-Lowering Medications
    A numerical count by class of drug of topical IOP lowering medications being taken.

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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.

Contacts and Locations

Sponsors and CollaboratorsAbbVie
Locations
Arizona Advanced Eye Research Institute /ID# 268363 | Glendale Arizona, United States, 85306LA Glaucoma Group /ID# 268444 | Culver City California, United States, 90232North Bay Eye Associates /ID# 277071 | Petaluma California, United States, 94954University Of Colorado - Anschutz Medical Campus /ID# 269947 | Aurora Colorado, United States, 80045Colorado Eye Institute /ID# 277072 | Colorado Springs Colorado, United States, 80924Brandon Eye Associates - Brandon /ID# 277074 | Brandon Florida, United States, 33511New Vision Eye Center /ID# 269955 | Vero Beach Florida, United States, 32960Coastal Research Associates - Roswell /ID# 268458 | Roswell Georgia, United States, 30076Illinois Eye Center - Peoria Location /ID# 277127 | Peoria Illinois, United States, 61615Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451 | Overland Park Kansas, United States, 66213Minnesota Eye Consultants - Minneapolis /ID# 272445 | Minneapolis Minnesota, United States, 55431Vance Thompson Vision - Omaha /ID# 271599 | Omaha Nebraska, United States, 68137Oklahoma Eye Surgeons /ID# 269174 | Oklahoma City Oklahoma, United States, 73112Ophthalmic Partners of PA /ID# 276059 | Bala-Cynwyd Pennsylvania, United States, 19004Wills Eye Hospital Glaucoma Dept /ID# 268569 | Philadelphia Pennsylvania, United States, 19107Glaucoma Associates Of Texas /ID# 268745 | Dallas Texas, United States, 75231UT Southwestern Medical Center /ID# 268571 | Dallas Texas, United States, 75390El Paso Eye Surgeons /ID# 268356 | El Paso Texas, United States, 79902Berkeley Eye Center - Houston Greenway Plaza /ID# 277078 | Houston Texas, United States, 77027University of Virginia /ID# 277487 | Charlottesville Virginia, United States, 22908Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119 | Roanoke Virginia, United States, 24016The Eye Centers of Racine and Kenosha LTD /ID# 271266 | Racine Wisconsin, United States, 53405
Investigators
Study Director: ABBVIE INC., AbbVie