A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China

April 23, 2026 updated by: AbbVie

A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China

Glaucoma is the second most common cause of blindness in the world, second only to cataracts. The purpose of this study is to assess adverse events (AEs) and changes in disease activity in participants with open-angle glaucoma (OAG) receiving the XEN45 Glaucoma Treatment System (XEN45).

XEN45 is an approved device for the treatment of OAG in participants in China who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (IOP)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. Adult participants with a diagnosis of OAG will be randomized to receive either XEN 45 or trabeculectomy. Around 130 participants will be enrolled in the study at approximately 15 sites in China.

Participants will receive XEN45 implanted using the ab interno approach or trabeculectomy on Day 1 and will be followed for 60 months

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Guangzhou, China, 510623
        • Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University people s hospital /ID# 265493
      • Beijing, Beijing Municipality, China, 100191
        • Peking University Third Hospital /ID# 243994
      • Beijing, Beijing Municipality, China, 100730
        • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • The First Affiliated Hospital Of Fujian Medical University /ID# 244004
      • Xiamen, Fujian, China, 390000
        • Xiamen Eye Center of Xiamen University /ID# 244000
    • Guangdong
      • Guangzhou, Guangdong, China, 510260
        • The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493
      • Shenzhen, Guangdong, China, 518034
        • Shenzhen Eye Hospital /ID# 244001
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Tongji Hospital Tongji Medical College of HUST /ID# 243998
    • Shandong
      • Qingdao, Shandong, China, 266071
        • Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital, Sichuan University /ID# 243999
    • Tianjin Municipality
      • Tianjin, Tianjin Municipality, China, 300070
        • Tianjin Eye Hospital /ID# 243997
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310009
        • The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: XEN45
Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.
Device: XEN45 Glaucoma Treatment System
Ab interno implantation
Active Comparator: Trabeculectomy
Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.
Procedure: Trabeculectomy
Surgical Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline in Intraocular Pressure (IOP)
Time Frame: Baseline to Month 12
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.
Baseline to Month 12
Number of Participants with Adverse Events (AEs)
Time Frame: Baseline to Month 60
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Baseline to Month 60

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction
Time Frame: Baseline to Month 12
Treatment response is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications without secondary surgical intervention (SSI) for uncontrolled IOP.
Baseline to Month 12
Change from Baseline in IOP by Visit
Time Frame: Baseline to Month 12
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.
Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
Time Frame: Baseline to Month 12
A numerical count by class of drug of topical IOP lowering medications being taken.
Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
Time Frame: Baseline to Month 12
The complete treatment response is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of IOP without topical IOP medications from baseline.
Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline With Any Topical IOP-Lowering Medications
Time Frame: Baseline to Month 12
The qualified treatment response is defined as the percentage of participants achieving IOP <= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications.
Baseline to Month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 9, 2024

Primary Completion (Estimated)

July 1, 2030

Study Completion (Estimated)

July 1, 2030

Study Registration Dates

First Submitted

March 23, 2023

First Submitted That Met QC Criteria

April 18, 2023

First Posted (Actual)

April 20, 2023

Study Record Updates

Last Update Posted (Actual)

April 28, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1924-802-007

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD Sharing Time Frame

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD Sharing Access Criteria

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Open-angle Glaucoma

Clinical Trials on XEN45 Glaucoma Treatment System

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Montenegro

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe