Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
NCT ID: NCT05024695
Last Updated: 2025-09-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
975 participants
INTERVENTIONAL
2021-08-19
2029-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Implant Group
MINIject™ Implant
The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space.
Interventions
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MINIject™ Implant
The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* Diagnosed degenerative visual disorders
* Clinically significant intraocular inflammation or infection
46 Years
ALL
No
Sponsors
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iSTAR Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Sabine Glibert
Role: STUDY_DIRECTOR
iSTAR Medical
Locations
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Arizona Advanced Eye Research Institute
Glendale, Arizona, United States
Vold Vision
Fayetteville, Arkansas, United States
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, United States
Reeve Woods Eye Center
Chico, California, United States
Sacramento Eye Consultants, A Medical Corporation
Sacramento, California, United States
Grand Junction Eye Care
Grand Junction, Colorado, United States
Eye Associates of Fort Myers
Fort Myers, Florida, United States
Intermountain Eye Center
Eagle, Idaho, United States
Illinois Eye Center
Peoria, Illinois, United States
Virdi Eye Clinic
Rock Island, Illinois, United States
Stiles Eyecare Excellene and Glaucoma Institute
Overland Park, Kansas, United States
LA Eye and Laser
Alexandria, Louisiana, United States
Minnesota Eye Consultants
Bloomington, Minnesota, United States
Eye Consultants PC
Omaha, Nebraska, United States
Center for Sight Las Vegas
Las Vegas, Nevada, United States
NYU Langone Ophthalmology
New York, New York, United States
Apex Eye Clinical Research, LLC
Mason, Ohio, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, United States
Vanderbilt Eye Institute
Nashville, Tennessee, United States
Glaucoma Associates of Texas
Dallas, Texas, United States
El Paso Eye Surgeons
El Paso, Texas, United States
Ophthalmology Associates
Fort Worth, Texas, United States
Houston Eye Associates
Houston, Texas, United States
Berkeley Eye Center
Houston, Texas, United States
R and R Eye Research
San Antonio, Texas, United States
The Eye Institute of Utah
Salt Lake City, Utah, United States
Spokane Eye Clinical Research
Spokane, Washington, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, United States
Prism Eye Institute
Oakville, Ontario, Canada
The Institute de l'Oeil des Laurentides
Boisbriand, Quebec, Canada
Clinique Opthalmologies Bellevue
Montreal, , Canada
Swiss Glaucoma Research Foundation Swiss Visio Montchoisi
Lausanne, , Switzerland
Queen Victoria Hospital NHS Foundation Trust
East Grinstead, , United Kingdom
Glaucoma Service Moorfields Eye Hospital
London, , United Kingdom
Imperial College Healthcare NHS Trust Western Eye Hospital
London, , United Kingdom
KCL Frost Eye Research Department St Thomas' Hospital
London, , United Kingdom
Research & Development Unit, Learning and Research Centre (LaRC), York Hospital
York, , United Kingdom
Countries
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Other Identifiers
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ISM06 (STAR-V)
Identifier Type: -
Identifier Source: org_study_id
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