Clinical trial NCT05024695: Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
Official title: A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glaucoma
Keywords: glaucoma
MIGS
primary open angle glaucoma
suprachoroidal space
supraciliary space
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2021-08-27
Enrollment: 975
Sex: ALL
Minimum age (years): 46
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

Detailed description: This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.

Eligibility criteria: Key Inclusion Criteria:

* Males and females, 46 years of age or older
* A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
* Pseudophakic with prior uncomplicated cataract surgery

Key Exclusion Criteria:

* Angle closure, congenital, or secondary glaucoma
* Diagnosed degenerative visual disorders
* Clinically significant intraocular inflammation or infection

Primary outcomes:
measure: Intraocular pressure decrease
timeFrame: 24 months
measure: Intraocular pressure decrease (outcome 2)
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Glendale
country: United States
facility: Arizona Advanced Eye Research Institute
state: Arizona
city: Fayetteville
country: United States
facility: Vold Vision
state: Arkansas
city: Beverly Hills
country: United States
facility: Beverly Hills Institute of Ophthalmology
state: California
city: Chico
country: United States
facility: Reeve Woods Eye Center
state: California
city: Sacramento
country: United States
facility: Sacramento Eye Consultants, A Medical Corporation
state: California
city: Grand Junction
country: United States
facility: Grand Junction Eye Care
state: Colorado
city: Fort Myers
country: United States
facility: Eye Associates of Fort Myers
state: Florida
city: Eagle
country: United States
facility: Intermountain Eye Center
state: Idaho
city: Peoria
country: United States
facility: Illinois Eye Center
state: Illinois
city: Rock Island
country: United States
facility: Virdi Eye Clinic
state: Illinois
city: Overland Park
country: United States
facility: Stiles Eyecare Excellene and Glaucoma Institute
state: Kansas
city: Alexandria
country: United States
facility: LA Eye and Laser
state: Louisiana
city: Bloomington
country: United States
facility: Minnesota Eye Consultants
state: Minnesota
city: Omaha
country: United States
facility: Eye Consultants PC
state: Nebraska
city: Las Vegas
country: United States
facility: Center for Sight Las Vegas
state: Nevada
city: New York
country: United States
facility: NYU Langone Ophthalmology
state: New York
city: Mason
country: United States
facility: Apex Eye Clinical Research, LLC
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Eye Surgeons
state: Oklahoma
city: Nashville
country: United States
facility: Vanderbilt Eye Institute
state: Tennessee
city: Dallas
country: United States
facility: Glaucoma Associates of Texas
state: Texas
city: El Paso
country: United States
facility: El Paso Eye Surgeons
state: Texas
city: Fort Worth
country: United States
facility: Ophthalmology Associates
state: Texas
city: Houston
country: United States
facility: Houston Eye Associates
state: Texas
city: Houston
country: United States
facility: Berkeley Eye Center
state: Texas
city: San Antonio
country: United States
facility: R and R Eye Research
state: Texas
city: Salt Lake City
country: United States
facility: The Eye Institute of Utah
state: Utah
city: Spokane
country: United States
facility: Spokane Eye Clinical Research
state: Washington
city: Kenosha
country: United States
facility: Eye Centers of Racine and Kenosha
state: Wisconsin
city: Oakville
country: Canada
facility: Prism Eye Institute
state: Ontario
city: Boisbriand
country: Canada
facility: The Institute de l'Oeil des Laurentides
state: Quebec
city: Montréal
country: Canada
facility: Clinique Opthalmologies Bellevue
city: Lausanne
country: Switzerland
facility: Swiss Glaucoma Research Foundation Swiss Visio Montchoisi
city: East Grinstead
country: United Kingdom
facility: Queen Victoria Hospital NHS Foundation Trust
city: London
country: United Kingdom
facility: Glaucoma Service Moorfields Eye Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust Western Eye Hospital
city: London
country: United Kingdom
facility: KCL Frost Eye Research Department St Thomas' Hospital
city: York
country: United Kingdom
facility: Research &amp; Development Unit, Learning and Research Centre (LaRC), York Hospital
Study officials:
affiliation: iSTAR Medical
name: Richard Beckman, MD
role: STUDY_DIRECTOR
References: