Clinical trial NCT04333433: PRESERFLO® MicroShunt Extension Study
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Primary Open-angle Glaucoma
Keywords: POAG
Lead sponsor: InnFocus Inc.
Sponsor class: INDUSTRY
First posted: 2020-04-03
Enrollment: 279
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Sight-threatening Adverse Events
timeFrame: Month 36 thru Month 60
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Advance Eye Research Institute, LLC.
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Los Angeles
country: United States
facility: UCLA Medical Center Jules Stein Eye Institute
state: California
city: Sacramento
country: United States
facility: University of California at Davis Eye Center
state: California
city: Meriden
country: United States
facility: Ophthalmic Consultants of Connecticut
state: Connecticut
city: Eagle
country: United States
facility: Intermountain Eye Center
state: Idaho
city: Indianapolis
country: United States
facility: Eugene and Marilyn Glick Eye Institute
state: Indiana
city: Overland Park
country: United States
facility: Stiles Eye Care Excellence & Glaucoma Institute
state: Kansas
city: Bloomington
country: United States
facility: Minnesota Eye Consultants, PA
state: Minnesota
city: New York
country: United States
facility: New York Eye and Ear Infirmary of Mt. Sinai
state: New York
city: Slingerlands
country: United States
facility: Glaucoma Consultants of the Capital Region
state: New York
city: Cincinnati
country: United States
facility: Cincinnati Eye Institute
state: Ohio
city: Columbus
country: United States
facility: Ophthalmic Surgeons and Consultants of Ohio
state: Ohio
city: Oklahoma City
country: United States
facility: Dean McGee Eye Institute
state: Oklahoma
city: Bala-Cynwyd
country: United States
facility: Ophthalmic Partners of Pennsylvania
state: Pennsylvania
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Houston
country: United States
facility: University Eye Associates
state: Texas
city: San Antonio
country: United States
facility: R&R Eye Research, LLC
state: Texas
city: Pessac
country: France
facility: Pôle Ophtalmologique de la Clinique Mutualiste
state: Bordeaux
city: Pisa
country: Italy
facility: A. O.U.P (Azienda Ospedaliere Universitaria Pisana) Stabilimento di Cisanello
state: Cisanello
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
city: London
country: United Kingdom
facility: Moorfields Eye Hospital
Study officials:
affiliation: Bascolm Palmer Eye Institute
name: Paul Palmberg, MD, PhD
role: STUDY_DIRECTOR
References: