PRESERFLO® MicroShunt Extension Study

September 19, 2023 updated by: InnFocus Inc.

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

279

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Sight-threatening Adverse Events
Time Frame: Month 36 thru Month 60
Sight-threatening Adverse events (AEs) that were started after enrollment in the INN-005-EXT study through Month 60.
Month 36 thru Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

InnFocus Inc.

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 22, 2020

Primary Completion (Actual)

November 24, 2022

Study Completion (Actual)

November 24, 2022

Study Registration Dates

First Submitted

April 1, 2020

First Submitted That Met QC Criteria

April 1, 2020

First Posted (Actual)

April 3, 2020

Study Record Updates

Last Update Posted (Actual)

March 22, 2024

Last Update Submitted That Met QC Criteria

September 19, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • INN005 - EXT

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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