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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MicroShunt treatment group | Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device |
| |
| Trabeculectomy control arm | Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRESERFLO® MicroShunt | Device | Device surgically implanted |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Month 36 thru Month 60 |
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Inclusion Criteria:
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.
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The study population includes all living subjects who have completed the Month 24 Follow-Up Visit of the INN-005 clinical study after randomization to either the PRESERFLO® MicroShunt treatment arm or the Trabeculectomy control arm, and who are willing and able to extend their study participation and return for up to three (3) additional annual follow-up visits through post-operative Month 60. Up to 629 subjects may be enrolled at up to 24 sites located in the United States and at up to 5 sites located in Europe
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| Name | Affiliation | Role |
|---|---|---|
| Paul Palmberg, MD, PhD | Bascolm Palmer Eye Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Arizona Advance Eye Research Institute, LLC. | Glendale | Arizona | 85306 | United States | ||
| Vold Vision |
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Trabeculectomy Control Arm |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 16, 2021 | Aug 31, 2023 |
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| Trabeculectomy | Procedure | 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. |
|
| Fayetteville |
| Arkansas |
| 72704 |
| United States |
| UCLA Medical Center Jules Stein Eye Institute | Los Angeles | California | 90095 | United States |
| University of California at Davis Eye Center | Sacramento | California | 95817 | United States |
| Ophthalmic Consultants of Connecticut | Meriden | Connecticut | 06450 | United States |
| Intermountain Eye Center | Eagle | Idaho | 83616 | United States |
| Eugene and Marilyn Glick Eye Institute | Indianapolis | Indiana | 46290 | United States |
| Stiles Eye Care Excellence & Glaucoma Institute | Overland Park | Kansas | 66213 | United States |
| Minnesota Eye Consultants, PA | Bloomington | Minnesota | 55431 | United States |
| New York Eye and Ear Infirmary of Mt. Sinai | New York | New York | 10003 | United States |
| Glaucoma Consultants of the Capital Region | Slingerlands | New York | 12159 | United States |
| Cincinnati Eye Institute | Cincinnati | Ohio | 45242 | United States |
| Ophthalmic Surgeons and Consultants of Ohio | Columbus | Ohio | 43215 | United States |
| Dean McGee Eye Institute | Oklahoma City | Oklahoma | 73014 | United States |
| Ophthalmic Partners of Pennsylvania | Bala-Cynwyd | Pennsylvania | 19004 | United States |
| Glaucoma Associates of Texas | Dallas | Texas | 75231 | United States |
| Ophthalmology Associates | Fort Worth | Texas | 76102 | United States |
| University Eye Associates | Houston | Texas | 77030 | United States |
| R&R Eye Research, LLC | San Antonio | Texas | 78229 | United States |
| Pôle Ophtalmologique de la Clinique Mutualiste | Pessac | Bordeaux | 33600 | France |
| A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello | Pisa | Cisanello | 56124 | Italy |
| Hospital ClÃnico San Carlos | Madrid | 28040 | Spain |
| Moorfields Eye Hospital | London | EC1V 2PD | United Kingdom |
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.
| COMPLETED |
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| NOT COMPLETED |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Incidence of sight-threatening adverse events | Posted | Count of Participants | Participants | Month 36 thru Month 60 |
|
|
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 3 | 217 | 8 | 217 | 172 | 217 |
| EG001 | 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. | 0 | 62 | 0 | 62 | 47 | 62 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Choroidal Hemorrhage | Eye disorders | Systematic Assessment |
| ||
| Erosion of the Device through the Conjunctiva | Eye disorders | Systematic Assessment |
| ||
| Central Retinal Artery Occlusion | Eye disorders | Systematic Assessment |
| ||
| Pseudophakic Bullous Keratopathy | Eye disorders | Systematic Assessment |
| ||
| Endothelial Cell Loss | Eye disorders | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Worsening in the Visual Field Mean Deviation | Eye disorders | Systematic Assessment | Confirmed Worsening in the Visual Field Mean Deviation (MD) ≥2.5dB compared to MD |
| |
| Increased IOP Requiring Treatment | Eye disorders | Systematic Assessment |
| ||
| Cataract Progression | Eye disorders | Systematic Assessment |
| ||
| Loss 2 or More Lines of BCVA | Eye disorders | Systematic Assessment | Loss 2 or More Lines of BCVA on 2 Consecutive Standard Follow-ups 90 Days or more after Implantation (excluding Posterior Capsule Opacification, followed by post Nd: YAG Capsulotomy and improvement) |
| |
| Posterior Capsule Opacification | Eye disorders | Systematic Assessment |
| ||
| Ptosis | Eye disorders | Systematic Assessment |
| ||
| Bleb Related Complications | Eye disorders | Systematic Assessment | Bleb Related Complications e.g. cystic bleb, flat bleb |
| |
| Encapsulated Bleb | Eye disorders | Systematic Assessment |
| ||
| Hypotony | Eye disorders | Systematic Assessment | Hypotony (IOP <6mmHg at any Time) |
| |
| Diplopia | Eye disorders | Systematic Assessment |
| ||
| Dry Eye | Eye disorders | Systematic Assessment |
| ||
| Epiretinal Membrane | Eye disorders | Systematic Assessment |
| ||
| Meibomian Gland Disease | Eye disorders | Systematic Assessment |
|
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Edith van Dijkman | Santen, Inc. | +31683667357 | edith.vandijkman@santen.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 13, 2021 | Aug 31, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D005902 | Glaucoma, Open-Angle |
| ID | Term |
|---|---|
| D005901 | Glaucoma |
| D009798 | Ocular Hypertension |
| D005128 | Eye Diseases |
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| ID | Term |
|---|---|
| D014130 | Trabeculectomy |
| ID | Term |
|---|---|
| D018463 | Filtering Surgery |
| D013508 | Ophthalmologic Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| >=65 years |
|
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Italy |
|
| United Kingdom |
|
| France |
|
| Spain |
|
| Netherlands |
|