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
A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
1 other identifier
interventional
120
1 country
13
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2024
Longer than P75 for phase_4
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2023
CompletedFirst Posted
Study publicly available on registry
April 20, 2023
CompletedStudy Start
First participant enrolled
January 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2030
April 28, 2026
April 1, 2026
6.5 years
March 23, 2023
April 23, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from Baseline in Intraocular Pressure (IOP)
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)
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 Outcomes (5)
Percentage of Participants with Treatment Response of Achieving => 20% IOP Reduction
Baseline to Month 12
Change from Baseline in IOP by Visit
Baseline to Month 12
Change from Baseline in Number of Topical IOP-Lowering Medications
Baseline to Month 12
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
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
Baseline to Month 12
Study Arms (2)
XEN45
EXPERIMENTALParticipants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.
Trabeculectomy
ACTIVE COMPARATORParticipants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (13)
Peking University people s hospital /ID# 265493
Beijing, Beijing Municipality, 100044, China
Peking University Third Hospital /ID# 243994
Beijing, Beijing Municipality, 100191, China
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
Beijing, Beijing Municipality, 100730, China
The First Affiliated Hospital Of Fujian Medical University /ID# 244004
Fuzhou, Fujian, 350005, China
Xiamen Eye Center of Xiamen University /ID# 244000
Xiamen, Fujian, 390000, China
The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493
Guangzhou, Guangdong, 510260, China
Shenzhen Eye Hospital /ID# 244001
Shenzhen, Guangdong, 518034, China
Tongji Hospital Tongji Medical College of HUST /ID# 243998
Wuhan, Hubei, 430030, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992
Qingdao, Shandong, 266071, China
West China Hospital, Sichuan University /ID# 243999
Chengdu, Sichuan, 610041, China
Tianjin Eye Hospital /ID# 243997
Tianjin, Tianjin Municipality, 300070, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996
Hangzhou, Zhejiang, 310009, China
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
Guangzhou, 510623, China
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 23, 2023
First Posted
April 20, 2023
Study Start
January 9, 2024
Primary Completion (Estimated)
July 1, 2030
Study Completion (Estimated)
July 1, 2030
Last Updated
April 28, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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.