Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma

This study will evaluate the safety and IOP-lowering effectiveness of XEN in patients with Angle Closure Glaucoma.

Study Overview

• Status: Completed
• Conditions: Glaucoma; Angle-Closure
• Intervention / Treatment: Device: XEN45

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Paramatta, New South Wales, Australia, 2150
      • Marsden Eye Specialists Parramatta /ID# 232761
  • Victoria
    • Fitzroy, Victoria, Australia, VIC3065
      • Melbourne Eye Specialists /ID# 232767
    • Vermont South, Victoria, Australia, 3133
      • Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
• Canada
  • Mississauga, Canada, L5L 1W8
    • Prism Eye Institute /ID# 232917
  • Quebec
    • Boisbriand, Quebec, Canada, J7H 0E8
      • Institut de loeil des Laurentides /ID# 232780
    • Montreal, Quebec, Canada, H1V 1G5
      • Ophthalmology Clinic Bellevue /ID# 232782
• Korea, Republic of
  • Seoul, Korea, Republic of, 03080
    • Seoul National University Hospital /ID# 233099
• Singapore
  • Singapore, Singapore, 119082
    • Nuh Medical Centre /ID# 232905
  • Singapore, Singapore, 308433
    • Tan Tock Seng Hospital /ID# 233014
• Taiwan
  • Hualien, Taiwan, 97002
    • Buddhist Tzu Chi General Hospital /ID# 232664
  • Taipei
    • Taipei City, Taipei, Taiwan, 11217
      • Taipei Veterans General Hospital /ID# 232948
• United Kingdom
  • Colchester, United Kingdom, CO4 5JL
    • East Suffolk and North Essex NHS Foundation Trust /ID# 232804
  • Edinburgh, United Kingdom, EH3 9HE
    • NHS Lothian /ID# 233052
  • England
    • Guildford, England, United Kingdom, GU2 7XX
      • Royal Surrey County Hospital /ID# 233028
  • Lancashire
    • Manchester, Lancashire, United Kingdom, M13 9WL
      • Manchester University NHS Foundation Trust /ID# 232808
  • West Sussex
    • East Grinstead, West Sussex, United Kingdom, RH19 3DZ
      • Queen Victoria Hospital /ID# 232812

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Inclusion Criteria: - Diagnosis of ACG defined as areas of iridotrabecular contact present in ≥ 2 quadrants and glaucomatous damage to optic disc and visual field, in the study eye - Study eye has healthy, free, and mobile conjunctiva in the target quadrant Exclusion Criteria: - Uncontrolled systemic disease (eg, diabetes, hypertension) - Known history of bleeding disorder or prolonged bleeding after surgery or those on pharmacologic blood thinners other than aspirin (up to 100 mg/day) - History of dermatologic keloid formation - Open angle glaucoma, active acute angle closure attack, congenital glaucoma, juvenile glaucoma, secondary glaucoma in the study eye - History of following surgeries in the study eye: o incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions o corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty o previous laser or incisional intraocular surgery that might interfere with the outcome of this trial - Previous glaucoma shunt implantation in the target quadrant in the study eye - Active or history of chronic uveitis in the study eye - Unable to discontinue contact lens wear in the study eye during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: XEN45 Glaucoma Treatment System (hereafter referred to as XEN); XEN45 unilaterally implanted in the study eye	Device: XEN45; XEN45 unilaterally implanted in the study eye

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving at Least a 20% Reduction From Baseline Hour 0 IOP While on the Same Number or Fewer IOP Lowering Medications at Month 12	IOP will be measured using a Goldmann applanation tonometer	Month 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline the Number of Concomitant IOP-lowering Medications	The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.	Month 12

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Actual): March 18, 2022
• Study Completion (Actual): March 18, 2022

Study Registration Dates

• First Submitted: November 30, 2017
• First Submitted That Met QC Criteria: November 30, 2017
• First Posted (Actual): December 5, 2017

Study Record Updates

• Last Update Posted (Actual): May 17, 2023
• Last Update Submitted That Met QC Criteria: April 24, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Angle-Closure
• Other Study ID Numbers: 1924-701-007

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