Trial Outcomes & Findings for PRESERFLO® MicroShunt Extension Study (NCT NCT04333433)
NCT ID: NCT04333433
Last Updated: 2024-03-22
Results Overview
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
Recruitment status
COMPLETED
Target enrollment
279 participants
Primary outcome timeframe
Month 36 thru Month 60
Results posted on
2024-03-22
Participant Flow
This report presents data for 279 of subjects that completed the INN-005 Month 24 visit in the Phase II Pivotal Study who were enrolled in the INN-005 EXT study.
Participant milestones
| Measure |
MicroShunt Treatment Group
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
|---|---|---|
|
Overall Study
STARTED
|
217
|
62
|
|
Overall Study
COMPLETED
|
198
|
58
|
|
Overall Study
NOT COMPLETED
|
19
|
4
|
Reasons for withdrawal
| Measure |
MicroShunt Treatment Group
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
6
|
3
|
|
Overall Study
Death
|
3
|
0
|
|
Overall Study
Lost to Follow-up
|
6
|
1
|
|
Overall Study
2 PRESERFLO Early Exit 1 PRESERFLO PI decision 1 PRESERFLO Study Exit
|
4
|
0
|
Baseline Characteristics
PRESERFLO® MicroShunt Extension Study
Baseline characteristics by cohort
| Measure |
MicroShunt Treatment Group
n=217 Participants
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
n=62 Participants
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
Total
n=279 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
103 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
128 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
114 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
151 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
111 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
138 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
141 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
201 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
255 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
43 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
49 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
169 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
221 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
174 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
225 Participants
n=5 Participants
|
|
Region of Enrollment
Italy
|
5 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United Kingdom
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
France
|
11 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
Spain
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
12 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Month 36 thru Month 60Population: Incidence of sight-threatening adverse events
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
Outcome measures
| Measure |
MicroShunt Treatment Group
n=217 Participants
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
n=62 Participants
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
|---|---|---|
|
Incidence of Sight-threatening Adverse Events
|
4 Participants
|
0 Participants
|
Adverse Events
MicroShunt Treatment Group
Serious events: 8 serious events
Other events: 172 other events
Deaths: 3 deaths
Trabeculectomy Control Arm
Serious events: 0 serious events
Other events: 47 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
MicroShunt Treatment Group
n=217 participants at risk
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
n=62 participants at risk
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
|---|---|---|
|
Eye disorders
Choroidal Hemorrhage
|
0.46%
1/217 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
0.00%
0/62 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Erosion of the Device through the Conjunctiva
|
1.8%
4/217 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
0.00%
0/62 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Central Retinal Artery Occlusion
|
0.46%
1/217 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
0.00%
0/62 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Pseudophakic Bullous Keratopathy
|
0.46%
1/217 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
0.00%
0/62 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Endothelial Cell Loss
|
0.46%
1/217 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
0.00%
0/62 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
Other adverse events
| Measure |
MicroShunt Treatment Group
n=217 participants at risk
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device PRESERFLO® MicroShunt: Device surgically implanted
|
Trabeculectomy Control Arm
n=62 participants at risk
Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure Trabeculectomy: The procedure involves removal of a small portion of the trabecular meshwork and adjacent scleral tissue. Aqueous humor then drains into the subconjunctival space, creating a bleb on the external part of the eye, where it diffuses away.
|
|---|---|---|
|
Eye disorders
Worsening in the Visual Field Mean Deviation
|
24.9%
54/217 • Number of events 54 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
17.7%
11/62 • Number of events 11 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Increased IOP Requiring Treatment
|
26.3%
57/217 • Number of events 57 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
8.1%
5/62 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Cataract Progression
|
16.1%
35/217 • Number of events 35 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
19.4%
12/62 • Number of events 12 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Loss 2 or More Lines of BCVA
|
9.2%
20/217 • Number of events 20 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
6.5%
4/62 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Posterior Capsule Opacification
|
5.1%
11/217 • Number of events 11 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
9.7%
6/62 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Ptosis
|
3.7%
8/217 • Number of events 8 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
11.3%
7/62 • Number of events 7 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Bleb Related Complications
|
5.1%
11/217 • Number of events 11 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
4.8%
3/62 • Number of events 3 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Encapsulated Bleb
|
4.6%
10/217 • Number of events 10 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
6.5%
4/62 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Hypotony
|
2.8%
6/217 • Number of events 6 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
12.9%
8/62 • Number of events 8 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Diplopia
|
5.1%
11/217 • Number of events 11 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
1.6%
1/62 • Number of events 1 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Dry Eye
|
12.9%
28/217 • Number of events 28 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
22.6%
14/62 • Number of events 14 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Epiretinal Membrane
|
1.8%
4/217 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
8.1%
5/62 • Number of events 5 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
|
Eye disorders
Meibomian Gland Disease
|
1.8%
4/217 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
6.5%
4/62 • Number of events 4 • Adverse events (AEs) and Serious Adverse Events (SAEs) were reported for all events that started after enrollment in the INN-005 EXT study through Month 60.
Any untoward medical occurrence, unintended disease orinjury or any untoward clinical signs (including an abnormallaboratory finding) in subjects, users or other personswhether or not related to the investigational medical device.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place