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

NCT04303897 | Completed FDA Device

• 1 other identifier: 1924-801-007
• Study Type: observational
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Refractory Glaucoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Mean decrease in IOP

  Baseline to Month 12

Study Arms (1)

XEN Glaucoma Stent

Device: XEN Glaucoma Stent

Interventions

XEN Glaucoma Stent DEVICE

Data are collected from patients who are implanted with XEN via the specific urgent medical needs for named patient use regulatory pathway in Hainan

XEN Glaucoma Stent

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Allergan: lead

Study Sites (1)

Boao Super Hospital /ID# 233669

Qionghai, Hainan, 571434, China

Location

Related Links

• clinical study report synopsis

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• ALLERGAN INC.

  Allergan

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 9, 2020
• First Posted: March 11, 2020
• Study Start: December 19, 2019
• Primary Completion: March 3, 2022
• Study Completion: March 3, 2022
• Last Updated: April 12, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: For details on when studies are available for sharing, please refer to the link below.
• 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.

Locations

CN (1)