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New gel stent shows promise for glaucoma patients

NCT ID NCT05411198

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This study tested a gel stent implant for open-angle glaucoma, a leading cause of blindness. 74 adults aged 45+ received the implant and were followed for 12 months. The goal was to safely lower eye pressure and reduce the need for glaucoma medications.

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

74 people

The number who actually took part.

Started

Jul 2022

Finished

Feb 2026

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: * 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.

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Conditions

The condition(s) this trial relates to.

glaucoma neovascular glaucoma open-angle glaucoma

As listed by the trial registrant

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

Open angle glaucoma

Contacts and locations

Locations

  • Center for Sight - Sarasota /ID# 227577

    Sarasota, Florida, 34239, United States

  • East Coast Institute for Research /ID# 255508

    Jacksonville, Florida, 32256-9680, United States

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

    El Paso, Texas, 79902, United States

  • Eye Surgery Associates /ID# 252207

    East Melbourne, Victoria, 3002, Australia

  • Eye associates /ID# 227572

    San Antonio, Texas, 78229, United States

  • Fichte Endl & Elmer Eyecare /ID# 245165

    Niagara Falls, New York, 14304, United States

  • Georgia Eye Partners /ID# 245203

    Atlanta, Georgia, 30342, United States

  • Glaucoma Associates of Texas /ID# 227580

    Dallas, Texas, 75231, United States

  • Kremer Eye Center - King of Prussia /ID# 245573

    King of Prussia, Pennsylvania, 19406, United States

  • Melbourne Eye Specialists /ID# 252353

    Fitzroy, Victoria, VIC3065, Australia

  • NYU Langone Medical Center /ID# 227583

    New York, New York, 10016-6402, United States

  • New Vision Eye Center /ID# 261053

    Vero Beach, Florida, 32960-6551, United States

  • Northern Virginia Ophthalmology Associates -Falls Church /ID# 246925

    Falls Church, Virginia, 22042-3013, United States

  • Oklahoma Eye Surgeons /ID# 246840

    Oklahoma City, Oklahoma, 73112, United States

  • Ophthalmic Partners, PC /ID# 245367

    Bala-Cynwyd, Pennsylvania, 19004, United States

  • Stiles Eyecare Excellence /ID# 227576

    Overland Park, Kansas, 66213, United States

  • The Johns Hopkins Wilmer Eye Institute - Bethesda /ID# 245355

    Bethesda, Maryland, 20817, United States

  • UCLA Doheny Eye Center /ID# 227587

    Pasadena, California, 91105, United States

  • University of Texas Southwestern Medical Center /ID# 246848

    Dallas, Texas, 75390-7208, United States

  • University of Utah /ID# 245324

    Salt Lake City, Utah, 84112-5500, United States

  • Vance Thompson Vision /ID# 260892

    Sioux Falls, South Dakota, 57108, United States

  • Vance Thompson Vision /ID# 261125

    Alexandria, Minnesota, 56308-3408, United States

  • Ventura Ophthalmology /ID# 227585

    Ventura, California, 93003, United States

  • Vold Vision /ID# 245285

    Fayetteville, Arkansas, 72704, United States

  • Washington University-School of Medicine /ID# 245452

    St Louis, Missouri, 63110, United States

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