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

• Sponsor: Allergan (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04303897
• Collaborator: (none)
• Enrollment: 59
• Location: 1
• Actual Duration (Months): 26.4
• Patients Per Site Per Month: 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
Refractory Glaucoma	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:

• Additional information on study locations near you may be found at AllerganClinicalTrials.com.
• To be considered as a site for current and future Allergan Clinical Trials, please register using the Investigator Databank link.

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: Glaucoma

Study Results

No Results Posted as of Mar 25, 2022