Real-world Evidence Study of XEN in Chinese Patients With Refractory Glaucoma

A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma

Real-world evidence study to assess the safety and effectiveness of XEN® Glaucoma Treatment System in Chinese patients with refractory glaucoma. Participants will be (prospective) or have already been (retrospective) implanted with XEN via specific urgent medical need.

Study Overview

• Status: Completed
• Conditions: Refractory Glaucoma
• Intervention / Treatment: Device: XEN Glaucoma Stent

• Study Type: Observational
• Enrollment (Actual): 59

Contacts and Locations

Study Locations

• China
  • Hainan
    • Qionghai, Hainan, China, 571434
      • Boao Super Hospital /ID# 233669

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients are being implanted with the approved XEN product via the specific urgent medical needs for named patient use regulatory pathway in Hainan. The XEN Glaucoma Treatment System (XEN) is comprised of the XEN45 Gel Stent and XEN® Injector.

Description

Inclusion Criteria:

• Patients with refractory glaucomas, including cases where previous surgical treatment has failed, cases of POAG, and pseudoexfoliative or pigmentary glaucoma with open angles that are unresponsive to maximum tolerated medical therapy

Exclusion Criteria:

• Angle closure glaucoma where angle has not been surgically opened
• Previous glaucoma shunt/valve in the target quadrant
• Presence of conjunctival scarring, prior conjunctival surgery or other conjunctival pathologies (eg, pterygium) in the target quadrant
• Active inflammation (eg, blepharitis, conjunctivitis, keratitis, uveitis)
• Active iris neovascularization or neovascularization of the iris within six months of the surgical date
• Anterior chamber intraocular lens
• Presence of intraocular silicone oil
• Vitreous present in the anterior chamber

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
XEN Glaucoma Stent	Device: XEN Glaucoma Stent; Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Percentage of patients achieving at least a 20% reduction from intraocular pressure (IOP) while on the same number or fewer number of IOP lowering medications than at baseline	Baseline to Month 12

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean decrease in IOP	Baseline to Month 12

Collaborators and Investigators

• Sponsor: Allergan
• Investigators: Study Director: ALLERGAN INC., Allergan

Publications and helpful links

Helpful Links

• clinical study report synopsis

Study record dates

Study Major Dates

• Study Start (Actual): December 19, 2019
• Primary Completion (Actual): March 3, 2022
• Study Completion (Actual): March 3, 2022

Study Registration Dates

• First Submitted: March 9, 2020
• First Submitted That Met QC Criteria: March 9, 2020
• First Posted (Actual): March 11, 2020

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: 1924-801-007

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
• IPD Sharing Time Frame: For details on when studies are available for sharing, please refer to the link below.
• IPD Sharing Access Criteria: Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Use Agreement (DUA). For more information on the process, or to submit a request, visit the following link.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No