AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
Sponsor
AqueSys, Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT02036541
Collaborator
Allergan (Industry)
65
12
1
43
5.4
0.1
Study Details
Study Description
Brief Summary
To establish the safety and performance of the AqueSys XEN 45 Glaucoma Implant in eyes with refractory glaucoma.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Study Type:
Interventional
Actual Enrollment
:
65 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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 Start Date
:
Jan 1, 2013
Actual Primary Completion Date
:
Feb 1, 2016
Actual Study Completion Date
:
Aug 1, 2016
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: AqueSys XEN 45 Glaucoma Implant
|
Device: AqueSys XEN 45 Glaucoma Implant
Placement of the AqueSys XEN 45 Glaucoma Implant in the study eye
|
Outcome Measures
Primary Outcome Measures
- Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications [12 Months]
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 [12 Months]
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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
45 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | George R. Reiss, MD PC | Glendale | Arizona | United States | 85306 |
| 2 | Vold Vision | Fayetteville | Arkansas | United States | 72704 |
| 3 | Montebello Eye Center | Montebello | California | United States | 90640 |
| 4 | San Diego Eye Care Center | Oceanside | California | United States | 92056 |
| 5 | Palo Alto Eye Group | Palo Alto | California | United States | 94306 |
| 6 | Eye Center of Northern Colorado | Fort Collins | Colorado | United States | 80525 |
| 7 | Stiles Eyecare Excellence & Glaucoma Institute | Overland Park | Kansas | United States | 66213 |
| 8 | Washington University in St. Louis, Department of Ophthalmology | Saint Louis | Missouri | United States | 63110 |
| 9 | New York Eye and Ear Infirmary | New York | New York | United States | 10003 |
| 10 | Glaucoma Associates of Texas | Dallas | Texas | United States | 75231 |
| 11 | R and R Eye Research, LLC | San Antonio | Texas | United States | 78229 |
| 12 | Spokane Eye Clinic | Spokane | Washington | United States | 99204 |
Sponsors and Collaborators
- AqueSys, Inc.
- Allergan
Investigators
- Study Chair: Richard A Lewis, M.D., Grutzmacher, Lewis & Sierra Surgical Eye Specialists
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT02036541
Other Study ID Numbers:
- P13-001
First Posted:
Jan 15, 2014
Last Update Posted:
Jun 1, 2017
Last Verified:
May 1, 2017
Keywords provided by AqueSys, Inc.
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | XEN 45 Gel Stent |
|---|---|
| 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 |
Baseline Characteristics
| Arm/Group Title | XEN 45 Gel Stent |
|---|---|
| Arm/Group Description | Placement of the XEN 45 Gel Stent in the study eye |
| Overall Participants | 65 |
| Age (years) [Mean (Standard Deviation) ] | |
| Mean (Standard Deviation) [years] |
70
(12.3)
|
| Sex: Female, Male (Count of Participants) | |
| Female |
35
53.8%
|
| Male |
30
46.2%
|
| Ethnicity (NIH/OMB) (Count of Participants) | |
| Hispanic or Latino |
13
20%
|
| Not Hispanic or Latino |
52
80%
|
| Unknown or Not Reported |
0
0%
|
| Region of Enrollment (participants) [Number] | |
| United States |
65
100%
|
| Glaucoma Type (Count of 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 (Count of Participants) | |
| Count of Participants [Participants] |
45
69.2%
|
| Prior Glaucoma Procedure (Count of Participants) | |
| Prior incisional glaucoma procedure |
41
63.1%
|
| Prior laser trabeculoplasty |
14
21.5%
|
| No prior glaucoma procedure |
10
15.4%
|
Outcome Measures
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Placement of the XEN 45 Gel Stent in the study eye |
| Measure Participants | 61 |
| Count of Participants [Participants] |
46
70.8%
|
| 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 |
Outcome Measure Data
| 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 |
|---|---|
| Arm/Group Description | Placement of the XEN 45 Gel Stent in the study eye |
| Measure Participants | 61 |
| Mean (Standard Deviation) [mmHg] |
6.2
(9.1)
|
Adverse Events
| 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 | |
| Arm/Group Description | Placement of the XEN 45 Gel Stent in the study eye | |
All Cause Mortality |
||
| XEN 45 Gel Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 2/65 (3.1%) | |
Serious Adverse Events |
||
| XEN 45 Gel Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 9/65 (13.8%) | |
| Eye disorders | ||
| Explant | 1/65 (1.5%) | 1 |
| Secondary glaucoma procedure with explant | 6/65 (9.2%) | 6 |
| Secondary glaucoma procedure | 2/65 (3.1%) | 2 |
Other (Not Including Serious) Adverse Events |
||
| XEN 45 Gel Stent | ||
| Affected / at Risk (%) | # Events | |
| Total | 45/65 (69.2%) | |
| Eye disorders | ||
| Hypotony (IOP < 6 mmHg) | 16/65 (24.6%) | 18 |
| IOP increase ≥ 10 mmHg from baseline | 14/65 (21.5%) | 18 |
| Needling procedure | 21/65 (32.3%) | 29 |
| Wound dehiscence/leak | 6/65 (9.2%) | 6 |
| Wound repair | 5/65 (7.7%) | 6 |
| Anterior chamber tap | 6/65 (9.2%) | 7 |
| Best-Corrected Visual Acuity Loss of ≥ 2 lines ≤ 30 days postop | 10/65 (15.4%) | 10 |
| Best-Corrected Visual Acuity loss of ≥ 2 lines > 30 days | 7/65 (10.8%) | 7 |
| Best-Corrected Visual Acuity loss of ≥ 2 lines at 12 Months | 4/65 (6.2%) | 4 |
Limitations/Caveats
[Not Specified]
More Information
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
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 |
| rupali.nangia@allergan.com |
Responsible Party:
AqueSys, Inc.
ClinicalTrials.gov Identifier:
NCT02036541
Other Study ID Numbers:
- P13-001
First Posted:
Jan 15, 2014
Last Update Posted:
Jun 1, 2017
Last Verified:
May 1, 2017