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AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

Primary Purpose

Glaucoma, Glaucoma, Open Angle

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AqueSys XEN 45 Glaucoma Implant
Sponsored by
AqueSys, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma focused on measuring Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma

Eligibility Criteria

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

Inclusion Criteria:

  • Diagnosis of Refractory Glaucoma
  • Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg
  • Visual field mean deviation score of -3 dB or worse
  • Shaffer Angle Grade ≥ 3
  • Area of free, healthy and mobile conjunctiva in the targeted quadrant

Exclusion Criteria:

  • Active Neovascular Glaucoma
  • Previous glaucoma shunt/valve in the targeted quadrant
  • History of corneal surgery, opacities or disease/pathology
  • Anticipated need for ocular surgery
  • Non-study eye with BCVA of 20/200 or worse

Sites / Locations

  • George R. Reiss, MD PC
  • Vold Vision
  • Montebello Eye Center
  • San Diego Eye Care Center
  • Palo Alto Eye Group
  • Eye Center of Northern Colorado
  • Stiles Eyecare Excellence & Glaucoma Institute
  • Washington University in St. Louis, Department of Ophthalmology
  • New York Eye and Ear Infirmary
  • Glaucoma Associates of Texas
  • R and R Eye Research, LLC
  • Spokane Eye Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

AqueSys XEN 45 Glaucoma Implant

Arm Description

Outcomes

Primary Outcome Measures

Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
Mean Change in IOP From Baseline
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.

Secondary Outcome Measures

Full Information

First Posted
January 13, 2014
Last Updated
May 30, 2017
Sponsor
AqueSys, Inc.
Collaborators
Allergan
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1. Study Identification

Unique Protocol Identification Number
NCT02036541
Brief Title
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
Official Title
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Performance of the AqueSys XEN 45 Glaucoma Implant in Subjects With Refractory Glaucoma
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
February 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
Detailed Description
A prospective, multi-center, single arm, open-label clinical trial to evaluate the safety and IOP lowering performance of the AqueSys XEN 45 Glaucoma Implant in refractory glaucoma patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Glaucoma, Open Angle
Keywords
Glaucoma Implant, Trabeculectomy, POAG, Primary Open Angle Glaucoma, Pseudoexfoliation Glaucoma, Pigmentary Glaucoma

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
65 (Actual)

8. Arms, Groups, and Interventions

Arm Title
AqueSys XEN 45 Glaucoma Implant
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
AqueSys XEN 45 Glaucoma Implant
Intervention Description
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
Primary Outcome Measure Information:
Title
Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
Description
Proportion of subjects achieving a 20% or greater reduction in IOP from baseline on the same or less number of medications. Subjects who underwent a glaucoma-related secondary surgical intervention prior to the 12-month visit were considered failures in this analysis.
Time Frame
12 Months
Title
Mean Change in IOP From Baseline
Description
Mean change in IOP from baseline was calculated for subjects who completed the 12-month visit and the worst within-eye IOP was used for subjects who underwent a glaucoma-related secondary surgical intervention.
Time Frame
12 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Refractory Glaucoma Maximally-tolerated medicated IOP at two preoperative visits of ≥20 mmHg and ≤35 mmHg Visual field mean deviation score of -3 dB or worse Shaffer Angle Grade ≥ 3 Area of free, healthy and mobile conjunctiva in the targeted quadrant Exclusion Criteria: Active Neovascular Glaucoma Previous glaucoma shunt/valve in the targeted quadrant History of corneal surgery, opacities or disease/pathology Anticipated need for ocular surgery Non-study eye with BCVA of 20/200 or worse
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A Lewis, M.D.
Organizational Affiliation
Grutzmacher, Lewis & Sierra Surgical Eye Specialists
Official's Role
Study Chair
Facility Information:
Facility Name
George R. Reiss, MD PC
City
Glendale
State/Province
Arizona
ZIP/Postal Code
85306
Country
United States
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Facility Name
Montebello Eye Center
City
Montebello
State/Province
California
ZIP/Postal Code
90640
Country
United States
Facility Name
San Diego Eye Care Center
City
Oceanside
State/Province
California
ZIP/Postal Code
92056
Country
United States
Facility Name
Palo Alto Eye Group
City
Palo Alto
State/Province
California
ZIP/Postal Code
94306
Country
United States
Facility Name
Eye Center of Northern Colorado
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80525
Country
United States
Facility Name
Stiles Eyecare Excellence & Glaucoma Institute
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66213
Country
United States
Facility Name
Washington University in St. Louis, Department of Ophthalmology
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
New York Eye and Ear Infirmary
City
New York
State/Province
New York
ZIP/Postal Code
10003
Country
United States
Facility Name
Glaucoma Associates of Texas
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
R and R Eye Research, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Spokane Eye Clinic
City
Spokane
State/Province
Washington
ZIP/Postal Code
99204
Country
United States

12. IPD Sharing Statement

Citations:
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

AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

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