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
NCT ID: NCT05821855
Last Updated: 2025-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
130 participants
INTERVENTIONAL
2023-12-08
2030-07-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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XEN45
Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.
XEN45 Glaucoma Treatment System
Ab interno implantation
Trabeculectomy
Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.
Trabeculectomy
Surgical Intervention
Interventions
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XEN45 Glaucoma Treatment System
Ab interno implantation
Trabeculectomy
Surgical Intervention
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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ABBVIE INC.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Peking University people s hospital /ID# 265493
Beijing, Beijing Municipality, China
Peking University Third Hospital /ID# 243994
Beijing, Beijing Municipality, China
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055
Beijing, Beijing Municipality, China
The First Affiliated Hospital Of Fujian Medical University /ID# 244004
Fuzhou, Fujian, China
Xiamen Eye Center of Xiamen University /ID# 244000
Xiamen, Fujian, China
The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493
Guangzhou, Guangdong, China
Shenzhen Eye Hospital /ID# 244001
Shenzhen, Guangdong, China
Tongji Hospital Tongji Medical College of HUST /ID# 243998
Wuhan, Hubei, China
Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992
Qingdao, Shandong, China
West China Hospital, Sichuan University /ID# 243999
Chengdu, Sichuan, China
Tianjin Eye Hospital /ID# 243997
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996
Hangzhou, Zhejiang, China
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
Guangzhou, , China
Countries
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Central Contacts
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Related Links
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Other Identifiers
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1924-802-007
Identifier Type: -
Identifier Source: org_study_id
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