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

Sponsor
Allergan (Industry)
Overall Status
Completed
CT.gov ID
NCT04303897
Collaborator
(none)
59
1
26.4
2.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: XEN Glaucoma Stent

Study Design

Study Type:
Observational
Actual Enrollment :
59 participants
Observational Model:
Case-Only
Time Perspective:
Other
Official Title:
A Real-World Evidence Study to Evaluate the Safety and Effectiveness of XEN Glaucoma Treatment System (XEN) in Chinese Patients With Refractory Glaucoma
Actual Study Start Date :
Dec 19, 2019
Actual Primary Completion Date :
Mar 3, 2022
Actual Study Completion Date :
Mar 3, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  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 Outcome Measures

  1. Mean decrease in IOP [Baseline to Month 12]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boao Super Hospital /ID# 233669 Qionghai Hainan China 571434

Sponsors and Collaborators

  • Allergan

Investigators

  • Study Director: ALLERGAN INC., Allergan

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Allergan
ClinicalTrials.gov Identifier:
NCT04303897
Other Study ID Numbers:
  • 1924-801-007
First Posted:
Mar 11, 2020
Last Update Posted:
Mar 25, 2022
Last Verified:
Mar 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 25, 2022