PRESERFLO® MicroShunt Extension Study

• Sponsor: InnFocus Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT04333433
• Collaborator: (none)
• Enrollment: 300
• Locations: 24
• Anticipated Duration (Months): 31.3
• Patients Per Site: 12.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Primary Open-angle Glaucoma	Device: PRESERFLO® MicroShunt; Procedure: Trabeculectomy

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.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 300 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: A Prospective, Concurrent Controlled, Open-Label, Multicenter Clinical Study to Assess the Long-Term Safety of the PRESERFLO® MicroShunt in Subjects With Primary Open-Angle Glaucoma Who Have Completed Participation in the INN-005 Randomized Controlled Study.
• Actual Study Start Date: May 22, 2020
• Anticipated Primary Completion Date: Jan 1, 2023
• Anticipated Study Completion Date: Jan 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
MicroShunt treatment group Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 were implanted with the device	Device: PRESERFLO® MicroShunt; Device surgically implanted; Other Names: InnFocus MicroShunt® Glaucoma Drainage System
Trabeculectomy control arm Subjects previously randomized to this arm in pivotal study conducted under IDE G130028 underwent trabeculectomy procedure	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.

Outcome Measures

Primary Outcome Measures

1. Incidence of sight-threatening adverse events [Through 5 years postoperative follow-up]

   Incidence of sight-threatening adverse events, including but are not limited to events such as endophthalmitis, corneal decompensation, severe retinal detachment, severe choroidal hemorrhage, severe choroidal detachment, and aqueous misdirection

Eligibility Criteria

Criteria

• Ages Eligible for Study: 40 Years to 85 Years
• Sexes Eligible for Study: All

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arizona Advance Eye Research Institute, LLC.	Glendale	Arizona	United States	85306
2	Vold Vision	Fayetteville	Arkansas	United States	72704
3	UCLA Medical Center Jules Stein Eye Institute	Los Angeles	California	United States	90095
4	University of California at Davis Eye Center	Sacramento	California	United States	95817
5	Ophthalmic Consultants of Connecticut	Meriden	Connecticut	United States	06450
6	Intermountain Eye Center	Eagle	Idaho	United States	83616
7	Eugene and Marilyn Glick Eye Institute	Indianapolis	Indiana	United States	46290
8	Stiles Eye Care Excellence & Glaucoma Institute	Overland Park	Kansas	United States	66213
9	Minnesota Eye Consultants, PA	Bloomington	Minnesota	United States	55431
10	New York Eye and Ear Infirmary of Mt. Sinai	New York	New York	United States	10003
11	Glaucoma Consultants of the Capital Region	Slingerlands	New York	United States	12159
12	Cincinnati Eye Institute	Cincinnati	Ohio	United States	45242
13	Ophthalmic Surgeons and Consultants of Ohio	Columbus	Ohio	United States	43215
14	Dean McGee Eye Institute	Oklahoma City	Oklahoma	United States	73014
15	Ophthalmic Partners of Pennsylvania	Bala-Cynwyd	Pennsylvania	United States	19004
16	Glaucoma Associates of Texas	Dallas	Texas	United States	75231
17	Ophthalmology Associates	Fort Worth	Texas	United States	76102
18	University Eye Associates	Houston	Texas	United States	77030
19	R&R Eye Research, LLC	San Antonio	Texas	United States	78229
20	Pole Ophtalmologique de la Clinique Mutualiste	Pessac	Bordeaux	France	33600
21	Pôle Ophtalmologique de la Clinique Mutualiste	Pessac	Bordeaux	France	33600
22	A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello	Pisa	Cisanello	Italy	56124
23	Hospital Clínico San Carlos	Madrid		Spain	28040
24	Moorfields Eye Hospital	London		United Kingdom	EC1V 2PD

Sponsors and Collaborators

• InnFocus Inc.

Investigators

• Study Director: Paul Palmberg, MD, PhD, Bascolm Palmer Eye Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: InnFocus Inc.
• ClinicalTrials.gov Identifier: NCT04333433
• Other Study ID Numbers: INN005 - EXT
• First Posted: Apr 3, 2020
• Last Update Posted: Aug 31, 2021
• Last Verified: Aug 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by InnFocus Inc.: POAG
• Additional relevant MeSH terms: Glaucoma; Glaucoma, Open-Angle

Study Results

No Results Posted as of Aug 31, 2021