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A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China

Primary Purpose

Open-angle Glaucoma, OAG

Status
Not yet recruiting
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
XEN45 Glaucoma Treatment System
Trabeculectomy
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open-angle Glaucoma focused on measuring Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP

Eligibility Criteria

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

Inclusion Criteria: Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva Visible trabecular meshwork with Shaffer angle grade => 3 in the study eye at the Screening Visit. Medicated IOP => 20 mm Hg and <= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit. Exclusion Criteria: Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit. Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle).

Sites / Locations

  • Peking University Third Hospital /ID# 243994
  • Xiangya Hospital Central South University /ID# 244599
  • Jiangsu Province Hospital /ID# 244002
  • West China Hospital, Sichuan University /ID# 243999
  • The second Affiliated hospital of Zhejiang University school of Medicine /ID# 243996
  • Beijing Tongren Hospital, CMU /ID# 244055
  • The First Affiliated Hospital of Fujian Medical University /ID# 244004
  • Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
  • Qingdao Eye Hospital of Shandong First Medical University /ID# 243992
  • Tianjin Eye Hospital /ID# 243997
  • Eye Hospital, WMU Zhejiang Eye Hospital /ID# 243993
  • Xiamen Eye Center of Xiamen University /ID# 244000

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

XEN45

Trabeculectomy

Arm Description

Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.

Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.

Outcomes

Primary Outcome Measures

Change from Baseline (Medicated) in Mean Intraocular Pressure (IOP)
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Number of Participants with Adverse Events (AEs)
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Percentage of Participants Achieving => 20% Mean IOP Reduction
Effectiveness rate is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications with no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
Change from baseline (medicated) in mean IOP
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Change from baseline in mean number of topical IOP-lowering medications
A numerical count by class of drug of topical IOP lowering medications being taken.
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
The complete success rate is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of intraocular pressure (IOP) without topical glaucoma medications from baseline.
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline with any Topical IOP-lowering Medications
The qualified success rate is defined as the percentage of participants achieving IOP <= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications.

Full Information

First Posted
March 23, 2023
Last Updated
April 18, 2023
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT05821855
Brief Title
A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China
Official Title
A Postmarketing Study Evaluating the Effectiveness and Safety of the XEN45 Glaucoma Treatment System in Subjects With Open-Angle Glaucoma in China
Study Type
Interventional

2. Study Status

Record Verification Date
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 15, 2023 (Anticipated)
Primary Completion Date
July 29, 2029 (Anticipated)
Study Completion Date
July 29, 2029 (Anticipated)

3. Sponsor/Collaborators

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

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.
Yes
Data Monitoring Committee
No

5. Study Description

Brief Summary
Glaucoma is the second most common cause of blindness in the world, second only to cataracts. The purpose of this study is to assess adverse events (AEs) and changes in disease activity in participants with open-angle glaucoma (OAG) receiving the XEN45 Glaucoma Treatment System (XEN45). XEN45 is an approved device for the treatment of OAG in participants in China who have not achieved satisfactory effectiveness with or are not suitable for intraocular pressure (IOP)-lowering medication, laser surgery, or are not tolerant of traditional filtration surgery. Adult participants with a diagnosis of OAG will be randomized to receive either XEN 45 or trabeculectomy. Around 130 participants will be enrolled in the study at approximately 15 sites in China. Participants will receive XEN45 implanted using the ab interno approach or trabeculectomy on Day 1 and will be followed for 60 months An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open-angle Glaucoma, OAG
Keywords
Open-angle glaucoma, OAG, XEN45, Intraocular pressure, IOP

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
XEN45
Arm Type
Experimental
Arm Description
Participants will be implanted with the XEN45 glaucoma treatment system in the study eye on Day 1 and followed for 60 months.
Arm Title
Trabeculectomy
Arm Type
Active Comparator
Arm Description
Participants will undergo trabeculectomy in the study eye on Day 1 and followed for 60 months.
Intervention Type
Device
Intervention Name(s)
XEN45 Glaucoma Treatment System
Intervention Description
Ab interno implantation
Intervention Type
Procedure
Intervention Name(s)
Trabeculectomy
Intervention Description
Surgical Intervention
Primary Outcome Measure Information:
Title
Change from Baseline (Medicated) in Mean Intraocular Pressure (IOP)
Description
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
Baseline to Month 12
Title
Number of Participants with Adverse Events (AEs)
Description
An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
Time Frame
Baseline to Month 60
Secondary Outcome Measure Information:
Title
Percentage of Participants Achieving => 20% Mean IOP Reduction
Description
Effectiveness rate is defined as IOP reduction on the same or fewer number of topical IOP-lowering medications with no clinical hypotony, no loss of vision to count fingers or worse, and no secondary glaucoma surgical intervention.
Time Frame
Baseline to Month 12
Title
Change from baseline (medicated) in mean IOP
Description
IOP is a measurement of the fluid pressure inside the study eye. A negative change from baseline indicates an improvement and a positive change from baseline indicates a worsening.
Time Frame
Baseline to Month 12
Title
Change from baseline in mean number of topical IOP-lowering medications
Description
A numerical count by class of drug of topical IOP lowering medications being taken.
Time Frame
Baseline to Month 12
Title
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP reduction from Baseline Without Topical IOP-lowering Medications
Description
The complete success rate is defined as the percentage of participants achieving IOP <=18 mm Hg and 20% or more reduction of intraocular pressure (IOP) without topical glaucoma medications from baseline.
Time Frame
Baseline to Month 12
Title
Percentage of Participants Achieving IOP <= 18 mm Hg and => 20% mean IOP Reduction from Baseline with any Topical IOP-lowering Medications
Description
The qualified success rate is defined as the percentage of participants achieving IOP <= 18 mm Hg and 20% mean IOP reduction from baseline with any topical IOP-lowering medications.
Time Frame
Baseline to Month 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Area of healthy, free, and mobile conjunctiva in the target area in the study eye, i.e., superior bulbar conjunctiva Visible trabecular meshwork with Shaffer angle grade => 3 in the study eye at the Screening Visit. Medicated IOP => 20 mm Hg and <= 44 mm Hg for the study eye, measured by Goldmann applanation tonometer, at the Screening Visit and Baseline Visit. Exclusion Criteria: Active neovascular, uveitic, or angle-recession glaucoma or any glaucoma-associated vascular disorders within 6 months of the Screening Visit. Prior XEN45, transscleral cycloablative procedures (such as cyclophotocoagulation, micropulse cyclophotocoagulation, cryotherapy, ultrasonic circular cyclocoagulation [UC3], etc.) or prior major conjunctival surgery (i.e., scleral buckle).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Peking University Third Hospital /ID# 243994
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100191
Country
China
Facility Name
Xiangya Hospital Central South University /ID# 244599
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410008
Country
China
Facility Name
Jiangsu Province Hospital /ID# 244002
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
West China Hospital, Sichuan University /ID# 243999
City
Chengdu
State/Province
Sichuan
ZIP/Postal Code
610041
Country
China
Facility Name
The second Affiliated hospital of Zhejiang University school of Medicine /ID# 243996
City
Hangzhou
State/Province
Zhejiang
ZIP/Postal Code
310009
Country
China
Facility Name
Beijing Tongren Hospital, CMU /ID# 244055
City
Beijing
ZIP/Postal Code
100730
Country
China
Facility Name
The First Affiliated Hospital of Fujian Medical University /ID# 244004
City
Fuzhou
ZIP/Postal Code
350005
Country
China
Facility Name
Zhongshan Ophthalmic Center,SunYat-Sen University /ID# 243843
City
Guangzhou
ZIP/Postal Code
510060
Country
China
Facility Name
Qingdao Eye Hospital of Shandong First Medical University /ID# 243992
City
Qingdao
ZIP/Postal Code
266023
Country
China
Facility Name
Tianjin Eye Hospital /ID# 243997
City
Tianjin
ZIP/Postal Code
300020
Country
China
Facility Name
Eye Hospital, WMU Zhejiang Eye Hospital /ID# 243993
City
Wenzhou
ZIP/Postal Code
325027
Country
China
Facility Name
Xiamen Eye Center of Xiamen University /ID# 244000
City
Xiamen
ZIP/Postal Code
390000
Country
China

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, analyses plans, 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 visit https://vivli.org/ourmember/abbvie/
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 and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
IPD Sharing URL
https://vivli.org/ourmember/abbvie/
Links:
URL
http://www.abbvieclinicaltrials.com/study/?id=1924-802-007
Description
Related Info

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A Study to Evaluate Adverse Events and Change in Disease Activity With the XEN45 Glaucoma Treatment System Implantation In Adult Participants With Open-Angle Glaucoma in China

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