search
Back to results

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

Primary Purpose

Primary Open Angle Glaucoma

Status
Completed
Phase
Phase 4
Locations
International
Study Type
Interventional
Intervention
XEN® Gel Stent
Cataract Surgery
Sponsored by
AqueSys, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Open Angle Glaucoma focused on measuring XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of primary open angle glaucoma
  • Participants are taking at least one and no more than four topical IOP-lowering medications.

Exclusion Criteria:

  • Angle Closure Glaucoma
  • Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders
  • Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection)
  • Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant

Sites / Locations

  • University of Graz
  • University Augenklinik Salzburg
  • Vienna University
  • University Hospitals Leuven
  • University Eye Clinic Bochum-Langendreer
  • Klinik für Augenheilkunde
  • Klinik fur Augenheilkunde
  • University of Pisa
  • Clinica Oculistica, Universita' di Torino
  • Integrated University Hospital of Verona
  • Ophthalmology Department of the Military Health Service Institute
  • Hospital Meixeiro Servicio de Ofthalmologia
  • Hospital Universitario La Paz
  • Hospital Principe de Asturias
  • University of Geneva
  • Maidstone Hospital Eye, Ear and Mouth Unit
  • Birmingham Midland Eye Theaters
  • Moorfields Eye Hospital
  • St. Thomas Hospital
  • Pinderfields Hospital
  • Unidad Oftalmologica de Caracas

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

XEN® Gel Stent

XEN® Gel Stent with Cataract Surgery

Arm Description

The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.

The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.

Outcomes

Primary Outcome Measures

Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Mean Change From Baseline in IOP in the Study Eyes to Month 24
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.

Secondary Outcome Measures

Full Information

First Posted
December 2, 2013
Last Updated
January 25, 2019
Sponsor
AqueSys, Inc.
search

1. Study Identification

Unique Protocol Identification Number
NCT02006693
Brief Title
Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants
Official Title
Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects
Study Type
Interventional

2. Study Status

Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
December 5, 2013 (Actual)
Primary Completion Date
February 9, 2016 (Actual)
Study Completion Date
January 26, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AqueSys, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this study was to evaluate the AqueSys XEN Implant [XEN® Gel Stent (XEN45 Implant)] for the treatment of moderate primary open angle glaucoma (POAG) participants when medications have failed to control intraocular pressure (IOP). Effectiveness was evaluated by comparing medicated preoperative IOP to postoperative values. Additionally, the number of topical IOP-lowering medications at screening were compared to the number of IOP-lowering medications at 1 year.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Open Angle Glaucoma
Keywords
XEN, Primary Open Angle Glaucoma, Filtration Device, Ab interno

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
199 (Actual)

8. Arms, Groups, and Interventions

Arm Title
XEN® Gel Stent
Arm Type
Other
Arm Description
The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
Arm Title
XEN® Gel Stent with Cataract Surgery
Arm Type
Other
Arm Description
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Intervention Type
Device
Intervention Name(s)
XEN® Gel Stent
Other Intervention Name(s)
XEN Glaucoma Implant, XEN Gel Stent, XEN45 Implant
Intervention Description
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
Intervention Type
Procedure
Intervention Name(s)
Cataract Surgery
Intervention Description
Participants diagnosed with a cataract elected to have cataract surgery.
Primary Outcome Measure Information:
Title
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
Description
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time Frame
Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Title
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
Description
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 12 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time Frame
Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Title
Mean Change From Baseline in IOP in the Study Eyes to Month 24
Description
IOP is a measurement of the fluid pressure inside the eye. Two IOP measurements were taken, followed by a third if the first 2 differed by 3 mmHg or more. The measurements were averaged. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time Frame
Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Title
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
Description
The use of topical IOP-lowering medications was recorded at the preoperative screening visit and at the 24 Month postoperative visit. The study eye(s) is defined as an eye(s) that met IOP and IOP-lowering medication study inclusion criteria. A negative change from Baseline indicates improvement.
Time Frame
Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of primary open angle glaucoma Participants are taking at least one and no more than four topical IOP-lowering medications. Exclusion Criteria: Angle Closure Glaucoma Participant has neovascular, uveitic or angle recession glaucoma or any glaucoma associated with vascular disorders Clinically significant inflammation or infection in the study eye within 30 days prior to the preoperative visit (e.g., blepharitis, conjunctivitis, keratitis, uveitis, herpes simplex infection) Presence of conjunctival scarring or prior conjunctival surgery or other conjunctival pathologies (e.g., pterygium) in the target quadrant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vanessa Vera, MD
Organizational Affiliation
Allergan
Official's Role
Study Director
Facility Information:
Facility Name
University of Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
University Augenklinik Salzburg
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Vienna University
City
Vienna
ZIP/Postal Code
1090
Country
Austria
Facility Name
University Hospitals Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Facility Name
University Eye Clinic Bochum-Langendreer
City
Bochum
ZIP/Postal Code
44892
Country
Germany
Facility Name
Klinik für Augenheilkunde
City
Frankfurt
ZIP/Postal Code
D-60590
Country
Germany
Facility Name
Klinik fur Augenheilkunde
City
Neubrandenburg
ZIP/Postal Code
17036
Country
Germany
Facility Name
University of Pisa
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
Clinica Oculistica, Universita' di Torino
City
Torino
ZIP/Postal Code
10100
Country
Italy
Facility Name
Integrated University Hospital of Verona
City
Verona
ZIP/Postal Code
37126
Country
Italy
Facility Name
Ophthalmology Department of the Military Health Service Institute
City
Warsaw
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Hospital Meixeiro Servicio de Ofthalmologia
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital Universitario La Paz
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Principe de Asturias
City
Madrid
Country
Spain
Facility Name
University of Geneva
City
Geneva
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Maidstone Hospital Eye, Ear and Mouth Unit
City
Maidstone
State/Province
Kent
ZIP/Postal Code
ME16 9QQ
Country
United Kingdom
Facility Name
Birmingham Midland Eye Theaters
City
Birmingham
State/Province
West Midlands
ZIP/Postal Code
B18 7QH
Country
United Kingdom
Facility Name
Moorfields Eye Hospital
City
London
ZIP/Postal Code
EC1V2PD
Country
United Kingdom
Facility Name
St. Thomas Hospital
City
London
ZIP/Postal Code
SE17EH
Country
United Kingdom
Facility Name
Pinderfields Hospital
City
Wakefield
ZIP/Postal Code
WF14DG
Country
United Kingdom
Facility Name
Unidad Oftalmologica de Caracas
City
Caracas
Country
Venezuela

12. IPD Sharing Statement

Citations:
PubMed Identifier
30758653
Citation
Reitsamer H, Sng C, Vera V, Lenzhofer M, Barton K, Stalmans I; Apex Study Group. Two-year results of a multicenter study of the ab interno gelatin implant in medically uncontrolled primary open-angle glaucoma. Graefes Arch Clin Exp Ophthalmol. 2019 May;257(5):983-996. doi: 10.1007/s00417-019-04251-z. Epub 2019 Feb 13.
Results Reference
derived
PubMed Identifier
29267575
Citation
Ozal SA, Kaplaner O, Basar BB, Guclu H, Ozal E. An innovation in glaucoma surgery: XEN45 gel stent implantation. Arq Bras Oftalmol. 2017 Nov-Dec;80(6):382-385. doi: 10.5935/0004-2749.20170093.
Results Reference
derived

Learn more about this trial

Evaluation of the XEN Implant in Moderate Primary Open Angle Glaucoma (POAG) Participants

We'll reach out to this number within 24 hrs