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

NCT05821855 · tracked via the Priya Life Science China tracker

Sponsor

AbbVie

Phase

Phase 4

Started

2024-01-09

Last updated

2026-04-28

Condition(s) studied

Open-angle GlaucomaOAG

Investigational drug(s) / intervention(s)

XEN45 Glaucoma Treatment SystemTrabeculectomy

XEN45 Glaucoma Treatment System: Ab interno implantation

Trabeculectomy: Surgical Intervention

Study 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Change from Baseline in Intraocular Pressure (IOP) — 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.
Number of Participants with Adverse Events (AEs) — 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.

Trial sites (13)

Facility	City	Region
Peking University people s hospital /ID# 265493	Beijing	Beijing Municipality
Peking University Third Hospital /ID# 243994	Beijing	Beijing Municipality
Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055	Beijing	Beijing Municipality
The First Affiliated Hospital Of Fujian Medical University /ID# 244004	Fuzhou	Fujian
Xiamen Eye Center of Xiamen University /ID# 244000	Xiamen	Fujian
The Second Affiliated Hospital of Guangzhou Medical University /ID# 275493	Guangzhou	Guangdong
Shenzhen Eye Hospital /ID# 244001	Shenzhen	Guangdong
Tongji Hospital Tongji Medical College of HUST /ID# 243998	Wuhan	Hubei
Qingdao Eye Hospital Of Shandong First Medical University /ID# 243992	Qingdao	Shandong
West China Hospital, Sichuan University /ID# 243999	Chengdu	Sichuan
Tianjin Eye Hospital /ID# 243997	Tianjin	Tianjin Municipality
The Second Affiliated Hospital of Zhejiang University School of Medicine /ID# 243996	Hangzhou	Zhejiang
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843	Guangzhou	China

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05821855 on ClinicalTrials.gov ↗ ← All trials in China