PRESERFLO® MicroShunt Extension Study

Completed

• Conditions: Primary Open-angle Glaucoma

• Registration Number: NCT04333433
• Lead Sponsor: InnFocus Inc.

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.

Study Timeline

• Study First Submitted: 2020-04-01
• Study First Submitted QC: 2020-04-01
• Study First Posted: 2020-04-03
• Study Start: 2020-05-22
• Primary Completion: 2022-11-24
• Study Completion: 2022-11-24
• Status Verified: 2023-09
• Results First Submitted: 2023-09-19
• Results First Submitted QC: 2023-09-19
• Last Update Submitted: 2023-09-19
• Results First Posted: 2024-03-22
• Last Update Posted: 2024-03-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 279

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (23)

Arizona Advance Eye Research Institute, LLC.; 🇺🇸 Glendale, Arizona, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

UCLA Medical Center Jules Stein Eye Institute; 🇺🇸 Los Angeles, California, United States

University of California at Davis Eye Center; 🇺🇸 Sacramento, California, United States

Ophthalmic Consultants of Connecticut; 🇺🇸 Meriden, Connecticut, United States

Intermountain Eye Center; 🇺🇸 Eagle, Idaho, United States

Eugene and Marilyn Glick Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

Stiles Eye Care Excellence & Glaucoma Institute; 🇺🇸 Overland Park, Kansas, United States

Minnesota Eye Consultants, PA; 🇺🇸 Bloomington, Minnesota, United States

New York Eye and Ear Infirmary of Mt. Sinai; 🇺🇸 New York, New York, United States

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