Primary Open-angle Glaucoma
Conditions
Keywords
POAG
Brief summary
This prospective, concurrent controlled, open-label, multicenter study is designed to collect additional safety data through 5 years of follow-up for subjects randomized to either the treatment arm (PRESERFLO® MicroShunt with MMC) or the control arm (Trabeculectomy with MMC) of the INN-005 clinical study.
Detailed description
The objective of this study is to evaluate the long-term safety of the PRESERFLO® MicroShunt in subjects with Primary Open-Angle Glaucoma who have completed their Month 24 Follow-Up Visit in the INN-005 clinical study, by collecting safety data through 5 years post-operative follow-up.
Interventions
DEVICEPRESERFLO® MicroShunt
Device surgically implanted
PROCEDURETrabeculectomy
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.
Sponsors
InnFocus Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
40 Years to 85 Years
Inclusion criteria
1. Subject has completed their Month 24 Follow-Up Visit in the INN-005 clinical study conducted under IDE G130028. 2. Subject was randomized into the INN-005 study and received the PRESERFLO® MicroShunt device or trabeculectomy. (Subjects who have had the device explanted, or replaced with another device, may be included). 3. Subject is willing and able to comply with all study requirements, including signing an informed consent form.
Exclusion criteria
1\. Subject has exceeded the timeframe for the Month 60 Follow-Up Visit prior to enrollment for participation in this long-term follow-up study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Sight-threatening Adverse Events | Month 36 thru Month 60 | Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60. |
Countries
France, Italy, Spain, United Kingdom, United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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 | 217 |
| 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. | 62 |
| Total | 279 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | 2 PRESERFLO Early Exit 1 PRESERFLO PI decision 1 PRESERFLO Study Exit | 4 | 0 |
| Overall Study | Death | 3 | 0 |
| Overall Study | Lost to Follow-up | 6 | 1 |
| Overall Study | Withdrawal by Subject | 6 | 3 |
Baseline characteristics
| Characteristic | Trabeculectomy Control Arm | MicroShunt Treatment Group | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 37 Participants | 114 Participants | 151 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants | 103 Participants | 128 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 8 Participants | 16 Participants | 24 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 54 Participants | 201 Participants | 255 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) Black or African American | 6 Participants | 43 Participants | 49 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 52 Participants | 169 Participants | 221 Participants |
| Region of Enrollment France | 1 Participants | 11 Participants | 12 Participants |
| Region of Enrollment Italy | 1 Participants | 5 Participants | 6 Participants |
| Region of Enrollment Netherlands | 5 Participants | 12 Participants | 17 Participants |
| Region of Enrollment Spain | 2 Participants | 11 Participants | 13 Participants |
| Region of Enrollment United Kingdom | 2 Participants | 4 Participants | 6 Participants |
| Region of Enrollment United States | 51 Participants | 174 Participants | 225 Participants |
| Sex: Female, Male Female | 27 Participants | 111 Participants | 138 Participants |
| Sex: Female, Male Male | 35 Participants | 106 Participants | 141 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 217 | 0 / 62 |
| other Total, other adverse events | 172 / 217 | 47 / 62 |
| serious Total, serious adverse events | 8 / 217 | 0 / 62 |
Outcome results
Primary
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.
Time frame: Month 36 thru Month 60
Population: Incidence of sight-threatening adverse events
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MicroShunt Treatment Group | Incidence of Sight-threatening Adverse Events | 4 Participants |
| Trabeculectomy Control Arm | Incidence of Sight-threatening Adverse Events | 0 Participants |