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

Primary Purpose

Glaucoma, Angle-Closure

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
XEN45
Sponsored by
Allergan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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:

    • incisional refractive surgery (eg, radial keratotomy), other than astigmatic keratotomy or limbal relaxing incisions
    • corneal graft including partial grafts such as Descemet's stripping endothelial keratoplasty and Descemet's membrane endothelial keratoplasty
    • 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

Sites / Locations

  • Marsden Eye Specialists Parramatta /ID# 232761
  • Melbourne Eye Specialists /ID# 232767
  • Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
  • Institut de loeil des Laurentides /ID# 232780
  • Ophthalmology Clinic Bellevue /ID# 232782
  • Prism Eye Institute /ID# 232917
  • Seoul National University Hospital /ID# 233099
  • Nuh Medical Centre /ID# 232905
  • Tan Tock Seng Hospital /ID# 233014
  • Taipei Veterans General Hospital /ID# 232948
  • Buddhist Tzu Chi General Hospital /ID# 232664
  • Royal Surrey County Hospital /ID# 233028
  • Manchester University NHS Foundation Trust /ID# 232808
  • Queen Victoria Hospital /ID# 232812
  • East Suffolk and North Essex NHS Foundation Trust /ID# 232804
  • NHS Lothian /ID# 233052

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

XEN45 Glaucoma Treatment System (hereafter referred to as XEN)

Arm Description

XEN45 unilaterally implanted in the study eye

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

First Posted
November 30, 2017
Last Updated
April 24, 2023
Sponsor
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT03362931
Brief Title
Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Official Title
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the XEN45 Glaucoma Treatment System in Patients With Angle Closure Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
July 19, 2018 (Actual)
Primary Completion Date
March 18, 2022 (Actual)
Study Completion Date
March 18, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Allergan

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Angle-Closure

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XEN45 Glaucoma Treatment System (hereafter referred to as XEN)
Arm Type
Experimental
Arm Description
XEN45 unilaterally implanted in the study eye
Intervention Type
Device
Intervention Name(s)
XEN45
Intervention Description
XEN45 unilaterally implanted in the study eye
Primary Outcome Measure Information:
Title
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
Description
IOP will be measured using a Goldmann applanation tonometer
Time Frame
Month 12
Secondary Outcome Measure Information:
Title
Change From Baseline the Number of Concomitant IOP-lowering Medications
Description
The number of concomitant IOP-lowering medications following implantation will be compared with the number prior to implantation.
Time Frame
Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ALLERGAN INC.
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
Marsden Eye Specialists Parramatta /ID# 232761
City
Paramatta
State/Province
New South Wales
ZIP/Postal Code
2150
Country
Australia
Facility Name
Melbourne Eye Specialists /ID# 232767
City
Fitzroy
State/Province
Victoria
ZIP/Postal Code
VIC3065
Country
Australia
Facility Name
Eye Surgery Associates P/L ATF Eye Surgery Associates Unit Trust /ID# 232765
City
Vermont South
State/Province
Victoria
ZIP/Postal Code
3133
Country
Australia
Facility Name
Institut de loeil des Laurentides /ID# 232780
City
Boisbriand
State/Province
Quebec
ZIP/Postal Code
J7H 0E8
Country
Canada
Facility Name
Ophthalmology Clinic Bellevue /ID# 232782
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1V 1G5
Country
Canada
Facility Name
Prism Eye Institute /ID# 232917
City
Mississauga
ZIP/Postal Code
L5L 1W8
Country
Canada
Facility Name
Seoul National University Hospital /ID# 233099
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Name
Nuh Medical Centre /ID# 232905
City
Singapore
ZIP/Postal Code
119082
Country
Singapore
Facility Name
Tan Tock Seng Hospital /ID# 233014
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Facility Name
Taipei Veterans General Hospital /ID# 232948
City
Taipei City
State/Province
Taipei
ZIP/Postal Code
11217
Country
Taiwan
Facility Name
Buddhist Tzu Chi General Hospital /ID# 232664
City
Hualien
ZIP/Postal Code
97002
Country
Taiwan
Facility Name
Royal Surrey County Hospital /ID# 233028
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 7XX
Country
United Kingdom
Facility Name
Manchester University NHS Foundation Trust /ID# 232808
City
Manchester
State/Province
Lancashire
ZIP/Postal Code
M13 9WL
Country
United Kingdom
Facility Name
Queen Victoria Hospital /ID# 232812
City
East Grinstead
State/Province
West Sussex
ZIP/Postal Code
RH19 3DZ
Country
United Kingdom
Facility Name
East Suffolk and North Essex NHS Foundation Trust /ID# 232804
City
Colchester
ZIP/Postal Code
CO4 5JL
Country
United Kingdom
Facility Name
NHS Lothian /ID# 233052
City
Edinburgh
ZIP/Postal Code
EH3 9HE
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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 URL
https://vivli.org/ourmember/abbvie/

Learn more about this trial

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

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