RecruitingPhase 4NCT05821855

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


Sponsor

AbbVie

Enrollment

130 participants

Start Date

Dec 8, 2023

Study Type

INTERVENTIONAL

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates the safety and effectiveness of the XEN45 implant — a tiny tube placed in the eye to help fluid drain and reduce eye pressure — for adults with open-angle glaucoma in China. Open-angle glaucoma is the most common form of glaucoma, where fluid builds up in the eye and gradually damages the optic nerve, leading to vision loss. **You may be eligible if...** - You have open-angle glaucoma - Your eye pressure is between 20 and 44 mmHg at screening - The angle of your eye where fluid drains is wide enough (Shaffer grade 3 or above) - The tissue around your eye appears healthy enough for the implant **You may NOT be eligible if...** - You have certain other types of glaucoma (neovascular, uveitic, or angle-recession types) - You have had a previous XEN45 implant or certain other eye surgeries in that eye - You have had prior radiation therapy to the eye - You have serious eye infections or inflammation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEXEN45 Glaucoma Treatment System

Ab interno implantation

PROCEDURETrabeculectomy

Surgical Intervention


Locations(13)

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

View Full Details on ClinicalTrials.gov

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NCT05821855