PRESERFLO® MicroShunt Extension Study

Primary Open-angle Glaucoma Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333433
• Other study ID #: INN005 - EXT
• Status: Completed
• Start date: May 22, 2020
• Est. completion date: November 24, 2022

Study information

• Verified date: September 2023
• Source: InnFocus Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 279
• Est. completion date: November 24, 2022
• Est. primary completion date: November 24, 2022
• Gender: All
• Age group: 40 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Primary Open-angle Glaucoma

Intervention

Device:
• PRESERFLO® MicroShunt
Device surgically implanted

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.

Locations

Country	Name	City	State
France	Pôle Ophtalmologique de la Clinique Mutualiste	Pessac	Bordeaux
Italy	A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello	Pisa	Cisanello
Spain	Hospital Clínico San Carlos	Madrid
United Kingdom	Moorfields Eye Hospital	London
United States	Ophthalmic Partners of Pennsylvania	Bala-Cynwyd	Pennsylvania
United States	Minnesota Eye Consultants, PA	Bloomington	Minnesota
United States	Cincinnati Eye Institute	Cincinnati	Ohio
United States	Ophthalmic Surgeons and Consultants of Ohio	Columbus	Ohio
United States	Glaucoma Associates of Texas	Dallas	Texas
United States	Intermountain Eye Center	Eagle	Idaho
United States	Vold Vision	Fayetteville	Arkansas
United States	Ophthalmology Associates	Fort Worth	Texas
United States	Arizona Advance Eye Research Institute, LLC.	Glendale	Arizona
United States	University Eye Associates	Houston	Texas
United States	Eugene and Marilyn Glick Eye Institute	Indianapolis	Indiana
United States	UCLA Medical Center Jules Stein Eye Institute	Los Angeles	California
United States	Ophthalmic Consultants of Connecticut	Meriden	Connecticut
United States	New York Eye and Ear Infirmary of Mt. Sinai	New York	New York
United States	Dean McGee Eye Institute	Oklahoma City	Oklahoma
United States	Stiles Eye Care Excellence & Glaucoma Institute	Overland Park	Kansas
United States	University of California at Davis Eye Center	Sacramento	California
United States	R&R Eye Research, LLC	San Antonio	Texas
United States	Glaucoma Consultants of the Capital Region	Slingerlands	New York

Sponsors (1)

Lead Sponsor	Collaborator
InnFocus Inc.

Countries where clinical trial is conducted

United States,  France,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Month 36 thru Month 60