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

January 25, 2019 updated by: AqueSys, Inc.

Post Market Multicentric Evaluation of the AqueSys XEN Implant in Moderate Primary Open Angle Glaucoma Subjects

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

199

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Graz, Austria, 8036
        • University of Graz
      • Salzburg, Austria, 5020
        • University Augenklinik Salzburg
      • Vienna, Austria, 1090
        • Vienna University
  • Belgium
      • Leuven, Belgium, B-3000
        • University Hospitals Leuven
  • Germany
      • Bochum, Germany, 44892
        • University Eye Clinic Bochum-Langendreer
      • Frankfurt, Germany, D-60590
        • Klinik für Augenheilkunde
      • Neubrandenburg, Germany, 17036
        • Klinik für Augenheilkunde
  • Italy
      • Pisa, Italy, 56124
        • University of Pisa
      • Torino, Italy, 10100
        • Clinica Oculistica, Universita' di Torino
      • Verona, Italy, 37126
        • Integrated University Hospital of Verona
  • Poland
      • Warsaw, Poland, 04-141
        • Ophthalmology Department of the Military Health Service Institute
  • Spain
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
      • Madrid, Spain
        • Hospital Principe de Asturias
    • Pontevedra
      • Vigo, Pontevedra, Spain
        • Hospital Meixeiro Servicio de Ofthalmologia
  • Switzerland
      • Geneva, Switzerland, 1211
        • University of Geneva
  • United Kingdom
      • London, United Kingdom, EC1V2PD
        • Moorfields Eye Hospital
      • London, United Kingdom, SE17EH
        • St. Thomas Hospital
      • Wakefield, United Kingdom, WF14DG
        • Pinderfields Hospital
    • Kent
      • Maidstone, Kent, United Kingdom, ME16 9QQ
        • Maidstone Hospital Eye, Ear and Mouth Unit
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B18 7QH
        • Birmingham Midland Eye Theaters
  • Venezuela
      • Caracas, Venezuela
        • Unidad Oftalmologica de Caracas

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: XEN® Gel Stent
The XEN®45 Gel Stent (XEN45 implant) was placed in the study eye as a standalone procedure.
Device: XEN® Gel Stent
The XEN® Gel Stent (XEN45 implant) was placed in the study eye.
Other Names:
  • XEN Glaucoma Implant
  • XEN Gel Stent
  • XEN45 Implant
Other: XEN® Gel Stent with Cataract Surgery
The XEN® Gel Stent (XEN45 implant) with cataract surgery, occurred if the participant was diagnosed with a cataract.
Procedure: Cataract Surgery
Participants diagnosed with a cataract elected to have cataract surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Mean Intraocular Pressure (IOP) in the Study Eye to Month 12
Time Frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
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.
Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 12
Time Frame: Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
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.
Baseline (≤ 90 days Preoperative) to Month 12 (Postoperative)
Mean Change From Baseline in IOP in the Study Eyes to Month 24
Time Frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
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.
Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
Change From Baseline in the Number of Topical IOP-Lowering Medications in the Study Eyes to Month 24
Time Frame: Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)
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.
Baseline (≤ 90 days Preoperative) to Month 24 (Postoperative)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AqueSys, Inc.

Investigators

  • Study Director: Vanessa Vera, MD, Allergan

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 5, 2013

Primary Completion (Actual)

February 9, 2016

Study Completion (Actual)

January 26, 2017

Study Registration Dates

First Submitted

December 2, 2013

First Submitted That Met QC Criteria

December 5, 2013

First Posted (Estimate)

December 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 22, 2019

Last Update Submitted That Met QC Criteria

January 25, 2019

Last Verified

January 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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