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Tiny eye implant aims to lower glaucoma pressure

NCT ID NCT05821855

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests a small device called XEN45 that is implanted in the eye to help drain fluid and lower pressure in people with open-angle glaucoma. About 120 adults in China will receive either the XEN45 implant or standard glaucoma surgery. Researchers will track eye pressure and any side effects for 5 years to see how well the device works in real-world use.

What this could mean

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

Active substance
XEN45 glaucoma implant (a tiny drainage device placed in the eye)
What this could lead to
If successful, this could confirm that the XEN45 implant is a safe and effective option for lowering eye pressure in Chinese patients with open-angle glaucoma.
What could go wrong
This is a postmarketing study, so the device is already approved. However, it is still possible that side effects or limited long-term benefit may emerge, and results may not apply to all glaucoma patients.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

120 people

The number who actually took part.

Started

Jan 2024

Expected to finish

Jul 2030

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

18 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: * Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva. * Visible trabecular meshwork with Shaffer angle grade =\> 3 in the study eye at the Screening Visit. * IOP =\> 20 mm Hg and \<= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit. Exclusion Criteria: * Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit in the study eye. * Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation \[UC3\], etc.) or prior major conjunctival surgery (i.e., scleral buckle) in the study eye.

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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.

OAG Open angle glaucoma

Contacts and locations

Locations

  • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055

    Beijing, Beijing Municipality, 100730, China

  • Peking University Third Hospital /ID# 243994

    Beijing, Beijing Municipality, 100191, China

  • Peking University people s hospital /ID# 265493

    Beijing, Beijing Municipality, 100044, China

  • Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992

    Qingdao, Shandong, 266071, China

  • Shenzhen Eye Hospital /ID# 244001

    Shenzhen, Guangdong, 518034, China

  • The First Affiliated Hospital Of Fujian Medical University /ID# 244004

    Fuzhou, Fujian, 350005, China

  • The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493

    Guangzhou, Guangdong, 510260, China

  • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996

    Hangzhou, Zhejiang, 310009, China

  • Tianjin Eye Hospital /ID# 243997

    Tianjin, Tianjin Municipality, 300070, China

  • Tongji Hospital Tongji Medical College of HUST /ID# 243998

    Wuhan, Hubei, 430030, China

  • West China Hospital, Sichuan University /ID# 243999

    Chengdu, Sichuan, 610041, China

  • Xiamen Eye Center of Xiamen University /ID# 244000

    Xiamen, Fujian, 390000, China

  • Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843

    Guangzhou, 510623, China

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