Trial Outcomes & Findings for AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma (NCT NCT02036541)
NCT ID: NCT02036541
Last Updated: 2017-06-01
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
65 participants
Primary outcome timeframe
12 Months
Results posted on
2017-06-01
Participant Flow
Participant milestones
| Measure |
XEN 45 Gel Stent
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Overall Study
STARTED
|
65
|
|
Overall Study
Completed Endpoint Visit
|
54
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
16
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
AqueSys XEN 45 Glaucoma Implant in Refractory Glaucoma
Baseline characteristics by cohort
| Measure |
XEN 45 Gel Stent
n=65 Participants
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Age, Continuous
|
70 years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
35 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
30 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
52 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
65 participants
n=5 Participants
|
|
Glaucoma Type
Primary Open Angle Glaucoma
|
57 Participants
n=5 Participants
|
|
Glaucoma Type
Pseudoexfolative Glaucoma
|
6 Participants
n=5 Participants
|
|
Glaucoma Type
Pigmentary Glaucoma
|
1 Participants
n=5 Participants
|
|
Glaucoma Type
Mixed Mechanism Glaucoma
|
1 Participants
n=5 Participants
|
|
Previous Cataract Surgery
|
45 Participants
n=5 Participants
|
|
Prior Glaucoma Procedure
Prior incisional glaucoma procedure
|
41 Participants
n=5 Participants
|
|
Prior Glaucoma Procedure
Prior laser trabeculoplasty
|
14 Participants
n=5 Participants
|
|
Prior Glaucoma Procedure
No prior glaucoma procedure
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
XEN 45 Gel Stent
n=61 Participants
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Proportion of Subjects Achieving a 20% or Greater Reduction in IOP From Baseline on the Same or Less Number of Medications
|
46 Participants
|
PRIMARY outcome
Timeframe: 12 MonthsPopulation: 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.
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.
Outcome measures
| Measure |
XEN 45 Gel Stent
n=61 Participants
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Mean Change in IOP From Baseline
|
6.2 mmHg
Standard Deviation 9.1
|
Adverse Events
XEN 45 Gel Stent
Serious events: 9 serious events
Other events: 45 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
XEN 45 Gel Stent
n=65 participants at risk
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Eye disorders
Explant
|
1.5%
1/65 • Number of events 1 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Secondary glaucoma procedure with explant
|
9.2%
6/65 • Number of events 6 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Secondary glaucoma procedure
|
3.1%
2/65 • Number of events 2 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
Other adverse events
| Measure |
XEN 45 Gel Stent
n=65 participants at risk
Placement of the XEN 45 Gel Stent in the study eye
|
|---|---|
|
Eye disorders
Hypotony (IOP < 6 mmHg)
|
24.6%
16/65 • Number of events 18 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
IOP increase ≥ 10 mmHg from baseline
|
21.5%
14/65 • Number of events 18 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Needling procedure
|
32.3%
21/65 • Number of events 29 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Wound dehiscence/leak
|
9.2%
6/65 • Number of events 6 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Wound repair
|
7.7%
5/65 • Number of events 6 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Anterior chamber tap
|
9.2%
6/65 • Number of events 7 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Best-Corrected Visual Acuity Loss of ≥ 2 lines ≤ 30 days postop
|
15.4%
10/65 • Number of events 10 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Best-Corrected Visual Acuity loss of ≥ 2 lines > 30 days
|
10.8%
7/65 • Number of events 7 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
|
Eye disorders
Best-Corrected Visual Acuity loss of ≥ 2 lines at 12 Months
|
6.2%
4/65 • Number of events 4 • Ocular adverse events in the study are reported from the day of surgery (Day 0) through the 12-month visit
Ocular adverse events in the study eye are reported from the day of surgery through the 12-month visit.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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
- Publication restrictions are in place
Restriction type: OTHER