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New gel stent could help glaucoma patients see clearly

NCT ID NCT06822738

Disease control Sponsor: AbbVie Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 5 times

Summary

This study tests a gel stent implant designed to lower eye pressure in people with glaucoma. About 130 adults aged 45 and older will receive the stent through one of two surgical methods. Researchers will check safety and how well the stent reduces eye pressure over 12 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
gel stent (XEN63)
What this could lead to
If successful, this could offer a new surgical option to lower eye pressure in glaucoma patients who haven't responded to other treatments.
What could go wrong
This is a Phase 3 trial, but the device is still investigational. Results may not apply to all glaucoma types, and risks include surgical complications or the stent not working as expected.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 130 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

45 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

open-angle glaucoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary open-angle glaucoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    24 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Arizona Advanced Eye Research Institute /ID# 268363

    RECRUITING

    Glendale, Arizona, 85306, United States

  • Berkeley Eye Center - Houston Greenway Plaza /ID# 277078

    RECRUITING

    Houston, Texas, 77027, United States

  • Brandon Eye Associates - Brandon /ID# 277074

    RECRUITING

    Brandon, Florida, 33511, United States

  • Cincinnati Eye Institute /ID# 279773

    RECRUITING

    Cincinnati, Ohio, 45242, United States

  • Cleveland Clinic - Cleveland /ID# 277070

    RECRUITING

    Cleveland, Ohio, 44195, United States

  • Coastal Research Associates - Roswell /ID# 268458

    RECRUITING

    Roswell, Georgia, 30076, United States

  • Colorado Eye Institute /ID# 277072

    RECRUITING

    Colorado Springs, Colorado, 80924, United States

  • East Coast Institute for Research /ID# 280411

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • El Paso Eye Surgeons /ID# 268356

    RECRUITING

    El Paso, Texas, 79902, United States

  • Fraser Eye Care Center /ID# 281837

    RECRUITING

    Fraser, Michigan, 48026, United States

  • Glaucoma Associates Of Texas /ID# 268745

    RECRUITING

    Dallas, Texas, 75231, United States

  • Illinois Eye Center - Peoria Location /ID# 277127

    RECRUITING

    Peoria, Illinois, 61615, United States

  • LA Glaucoma Group /ID# 268444

    RECRUITING

    Culver City, California, 90232, United States

  • Minnesota Eye Consultants - Minneapolis /ID# 272445

    RECRUITING

    Minneapolis, Minnesota, 55431, United States

  • New Vision Eye Center /ID# 269955

    COMPLETED

    Vero Beach, Florida, 32960, United States

  • North Bay Eye Associates /ID# 277071

    RECRUITING

    Petaluma, California, 94954, United States

  • Oklahoma Eye Surgeons /ID# 269174

    RECRUITING

    Oklahoma City, Oklahoma, 73112, United States

  • Ophthalmic Partners of PA /ID# 276059

    RECRUITING

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Stiles Eyecare Excellence & Glaucoma Institute /ID# 268451

    COMPLETED

    Overland Park, Kansas, 66213, United States

  • The Eye Centers of Racine and Kenosha /ID# 271266

    RECRUITING

    Kenosha, Wisconsin, 53142, United States

  • Tulane University School of Medicine /ID# 277486

    RECRUITING

    New Orleans, Louisiana, 70112, United States

  • University Of Colorado - Anschutz Medical Campus /ID# 269947

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Texas - Southwestern Medical Center /ID# 268571

    RECRUITING

    Dallas, Texas, 75235, United States

  • University of Virginia /ID# 277487

    RECRUITING

    Charlottesville, Virginia, 22908, United States

  • Vance Thompson Vision - Omaha /ID# 271599

    RECRUITING

    Omaha, Nebraska, 68137, United States

  • Vistar Eye Center - Roanoke - South Jefferson Street /ID# 276119

    COMPLETED

    Roanoke, Virginia, 24016, United States

  • Wills Eye Hospital /ID# 268569

    RECRUITING

    Philadelphia, Pennsylvania, 19107, United States

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Other studies related to the condition(s) this trial covers.