Independent directory Public ClinicalTrials.gov records United States
Clinical Trials Finder
Objective public record navigation
ClinicalTrials.gov record
Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06822738

Public ClinicalTrials.gov record NCT06822738. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

View official ClinicalTrials.gov record → Back to search
ClinicalTrials.gov public records Last synced Sep 3, 2026, 2:59 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A 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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT06822738
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
AbbVie
Industry
Enrollment
130 participants

Conditions and interventions

Interventions

Device

Eligibility (public fields only)

Age range
45 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 10, 2025
Primary completion
Oct 31, 2028
Completion
Oct 31, 2028
Last update posted
Aug 13, 2026

2025 – 2028

United States locations

U.S. sites
28
U.S. states
17
U.S. cities
27
Facility City State ZIP Site status
Arizona Advanced Eye Research Institute /ID# 268363 Glendale Arizona 85306 Recruiting
LA Glaucoma Group /ID# 268444 Culver City California 90232 Recruiting
North Bay Eye Associates /ID# 277071 Petaluma California 94954 Recruiting
University Of Colorado - Anschutz Medical Campus /ID# 269947 Aurora Colorado 80045 Recruiting
Colorado Eye Institute /ID# 277072 Colorado Springs Colorado 80924 Recruiting
Eye Center of Northern Colorado /ID# 281798 Fort Collins Colorado 80528 Not yet recruiting
Brandon Eye Associates - Brandon /ID# 277074 Brandon Florida 33511 Recruiting
East Coast Institute for Research /ID# 280411 Jacksonville Florida 32256 Recruiting
New Vision Eye Center /ID# 269955 Vero Beach Florida 32960 Recruiting
Coastal Research Associates - Roswell /ID# 268458 Roswell Georgia 30076 Recruiting
Illinois Eye Center - Peoria Location /ID# 277127 Peoria Illinois 61615 Recruiting
Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451 Overland Park Kansas 66213 Completed
Tulane Center for Clinical Research /ID# 277486 New Orleans Louisiana 70112-2703 Recruiting
Fraser Eye Care Center /ID# 281837 Fraser Michigan 48026 Recruiting
Minnesota Eye Consultants - Minneapolis /ID# 272445 Minneapolis Minnesota 55431 Recruiting
Vance Thompson Vision - Omaha /ID# 271599 Omaha Nebraska 68137 Recruiting
Cincinnati Eye Institute /ID# 279773 Cincinnati Ohio 45242 Recruiting
Cleveland Clinic - Cleveland /ID# 277070 Cleveland Ohio 44195 Recruiting
Oklahoma Eye Surgeons /ID# 269174 Oklahoma City Oklahoma 73112 Recruiting
Ophthalmic Partners of PA /ID# 276059 Bala-Cynwyd Pennsylvania 19004 Recruiting
Wills Eye Hospital /ID# 268569 Philadelphia Pennsylvania 19107 Recruiting
Glaucoma Associates Of Texas /ID# 268745 Dallas Texas 75231 Recruiting
University of Texas - Southwestern Medical Center /ID# 268571 Dallas Texas 75235 Recruiting
El Paso Eye Surgeons /ID# 268356 El Paso Texas 79902 Recruiting
Berkeley Eye Center - Houston Greenway Plaza /ID# 277078 Houston Texas 77027 Recruiting
University of Virginia /ID# 277487 Charlottesville Virginia 22908 Recruiting
Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119 Roanoke Virginia 24016 Completed
The Eye Centers of Racine and Kenosha /ID# 271266 Kenosha Wisconsin 53142 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06822738, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 13, 2026 · Synced Sep 3, 2026

Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.

Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06822738 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →