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AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma

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ClinicalTrials.gov Identifier: NCT02036541
Recruitment Status : Completed
First Posted : January 15, 2014
Results First Posted : June 1, 2017
Last Update Posted : June 1, 2017
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
AqueSys, Inc.

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Glaucoma
Glaucoma, Open Angle
Intervention Device: AqueSys XEN 45 Glaucoma Implant
Enrollment 65
Recruitment Details  
Pre-assignment Details  
Arm/Group Title XEN 45 Gel Stent
Hide Arm/Group Description Placement of the XEN 45 Gel Stent in the study eye
Period Title: Overall Study
Started 65
Completed Endpoint Visit 54
Completed 49
Not Completed 16
Arm/Group Title XEN 45 Gel Stent
Hide Arm/Group Description Placement of the XEN 45 Gel Stent in the study eye
Overall Number of Baseline Participants 65
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 65 participants
70  (12.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Female
35
  53.8%
Male
30
  46.2%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Hispanic or Latino
13
  20.0%
Not Hispanic or Latino
52
  80.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 65 participants
65
Glaucoma Type  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Primary Open Angle Glaucoma
57
  87.7%
Pseudoexfolative Glaucoma
6
   9.2%
Pigmentary Glaucoma
1
   1.5%
Mixed Mechanism Glaucoma
1
   1.5%
Previous Cataract Surgery  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
45
  69.2%
Prior Glaucoma Procedure  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 65 participants
Prior incisional glaucoma procedure
41
  63.1%
Prior laser trabeculoplasty
14
  21.5%
No prior glaucoma procedure
10
  15.4%
1.Primary Outcome
Title Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.
Arm/Group Title XEN 45 Gel Stent
Hide Arm/Group Description:
Placement of the XEN 45 Gel Stent in the study eye
Overall Number of Participants Analyzed 61
Measure Type: Count of Participants
Unit of Measure: Participants
46
  75.4%
2.Primary Outcome
Title Mean Change in IOP From Baseline
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
All subjects who completed the 12-month visit or underwent a glaucoma-related secondary surgical procedure prior to the 12-month visit were evaluated in this analysis.
Arm/Group Title XEN 45 Gel Stent
Hide Arm/Group Description:
Placement of the XEN 45 Gel Stent in the study eye
Overall Number of Participants Analyzed 61
Mean (Standard Deviation)
Unit of Measure: mmHg
6.2  (9.1)
Time Frame Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Adverse Event Reporting Description Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
 
Arm/Group Title XEN 45 Gel Stent
Hide Arm/Group Description Placement of the XEN 45 Gel Stent in the study eye
All-Cause Mortality
XEN 45 Gel Stent
Affected / at Risk (%)
Total   2/65 (3.08%)    
Show Serious Adverse Events Hide Serious Adverse Events
XEN 45 Gel Stent
Affected / at Risk (%) # Events
Total   9/65 (13.85%)    
Eye disorders   
Explant *  1/65 (1.54%)  1
Secondary glaucoma procedure with explant *  6/65 (9.23%)  6
Secondary glaucoma procedure *  2/65 (3.08%)  2
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
XEN 45 Gel Stent
Affected / at Risk (%) # Events
Total   45/65 (69.23%)    
Eye disorders   
Hypotony (IOP < 6 mmHg) * [1]  16/65 (24.62%)  18
IOP increase ≥ 10 mmHg from baseline *  14/65 (21.54%)  18
Needling procedure * [2]  21/65 (32.31%)  29
Wound dehiscence/leak *  6/65 (9.23%)  6
Wound repair *  5/65 (7.69%)  6
Anterior chamber tap *  6/65 (9.23%)  7
Best-Corrected Visual Acuity Loss of ≥ 2 lines ≤ 30 days postop *  10/65 (15.38%)  10
Best-Corrected Visual Acuity loss of ≥ 2 lines > 30 days *  7/65 (10.77%)  7
Best-Corrected Visual Acuity loss of ≥ 2 lines at 12 Months *  4/65 (6.15%)  4
*
Indicates events were collected by non-systematic assessment
[1]
All IOP < 6 mmHg was recorded as an adverse event, regardless of whether there were any associated complications or sequelae related to the low pressure. No clinically-significant consequences were associated with these hypotony cases
[2]
The protocol required these procedures to be recorded as adverse events
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The disclosure restriction on the PI is that the results of the multi-center trial must be published first, prior to any of the individual data being published
Results Point of Contact
Name/Title: Rupali Nangia
Organization: Allergan plc
Phone: 714-246-6020
Responsible Party: AqueSys, Inc.
ClinicalTrials.gov Identifier: NCT02036541     History of Changes
Other Study ID Numbers: P13-001
First Submitted: January 13, 2014
First Posted: January 15, 2014
Results First Submitted: May 1, 2017
Results First Posted: June 1, 2017
Last Update Posted: June 1, 2017