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

Last updated: January 22, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

4

Condition

Glaucoma

Treatment

Trabeculectomy

XEN45 Glaucoma Treatment System

Clinical Study ID

NCT05821855
1924-802-007
  • Ages > 18
  • All Genders

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 Criteria

Inclusion

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 theScreening Visit.

  • IOP => 20 mm Hg and <= 44 mm Hg for the study eye, measured by Goldmann applanationtonometer, at the Screening Visit and Baseline Visit.

Exclusion

Exclusion Criteria:

  • Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associatedvascular 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 studyeye.

Study Design

Total Participants: 130
Treatment Group(s): 2
Primary Treatment: Trabeculectomy
Phase: 4
Study Start date:
December 08, 2023
Estimated Completion Date:
July 31, 2030

Connect with a study center

  • Beijing Tongren Hospital Affiliated To Capital Medical University /ID# 244055

    Beijing, Beijing 100730
    China

    Active - Recruiting

  • Peking University Third Hospital /ID# 243994

    Beijing, Beijing 100191
    China

    Active - Recruiting

  • Peking University people's hospital /ID# 265493

    Beijing, Beijing 100044
    China

    Active - Recruiting

  • The First Affiliated Hospital Of Fujian Medical University /ID# 244004

    Fuzhou, Fujian 350005
    China

    Active - Recruiting

  • Xiamen Eye Center of Xiamen University /ID# 244000

    Xiamen, Fujian 390000
    China

    Active - Recruiting

  • Shenzhen Eye Hospital /ID# 244001

    Shenzhen, Guangdong 518034
    China

    Active - Recruiting

  • Tongji Hospital Tongji Medical College of HUST /ID# 243998

    Wuhan, Hubei 430030
    China

    Active - Recruiting

  • Xiangya Hospital Central South University /ID# 244599

    Changsha, Hunan 410008
    China

    Site Not Available

  • Jiangsu Province Hospital /ID# 244002

    Nanjing, Jiangsu 210029
    China

    Site Not Available

  • Qingdao Eye Hospital of Shandong First Medical University /ID# 243992

    Qingdao, Shandong 266023
    China

    Active - Recruiting

  • West China Hospital, Sichuan University /ID# 243999

    Chengdu, Sichuan 610041
    China

    Active - Recruiting

  • Tianjin Eye Hospital /ID# 243997

    Tianjin, Tianjin 300070
    China

    Active - Recruiting

  • The second affiliated hospital of Zhejiang University school of medicine /ID# 243996

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

  • Beijing Tongren Hospital, CMU /ID# 244055

    Beijing, 100730
    China

    Active - Recruiting

  • The First Affiliated Hospital of Fujian Medical University /ID# 244004

    Fuzhou, 350005
    China

    Site Not Available

  • Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843

    Guangzhou, 510623
    China

    Active - Recruiting

  • Eye Hospital, WMU Zhejiang Eye Hospital /ID# 243993

    Wenzhou, 325027
    China

    Site Not Available

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