Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
STAR-V
A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
1 other identifier
interventional
975
4 countries
37
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2021
Longer than P75 for not_applicable
37 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 19, 2021
CompletedFirst Submitted
Initial submission to the registry
August 23, 2021
CompletedFirst Posted
Study publicly available on registry
August 27, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2029
September 12, 2025
June 1, 2025
5.9 years
August 23, 2021
September 7, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Intraocular pressure decrease
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
24 months
Intraocular pressure decrease (outcome 2)
Change from baseline in mean unmedicated diurnal IOP at Month 24.
24 months
Study Arms (1)
Implant Group
EXPERIMENTALInterventions
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
You may qualify if:
- 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
You may not qualify if:
- Angle closure, congenital, or secondary glaucoma
- Diagnosed degenerative visual disorders
- Clinically significant intraocular inflammation or infection
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iSTAR Medicallead
Study Sites (37)
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306, United States
Vold Vision
Fayetteville, Arkansas, 72704, United States
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210, United States
Reeve Woods Eye Center
Chico, California, 95926, United States
Sacramento Eye Consultants, A Medical Corporation
Sacramento, California, 95815, United States
Grand Junction Eye Care
Grand Junction, Colorado, 81501, United States
Eye Associates of Fort Myers
Fort Myers, Florida, 33901, United States
Intermountain Eye Center
Eagle, Idaho, 83616, United States
Illinois Eye Center
Peoria, Illinois, 61615, United States
Virdi Eye Clinic
Rock Island, Illinois, 61201, United States
Stiles Eyecare Excellene and Glaucoma Institute
Overland Park, Kansas, 66213, United States
LA Eye and Laser
Alexandria, Louisiana, 71303, United States
Minnesota Eye Consultants
Bloomington, Minnesota, 55431, United States
Eye Consultants PC
Omaha, Nebraska, 68124, United States
Center for Sight Las Vegas
Las Vegas, Nevada, 89145, United States
NYU Langone Ophthalmology
New York, New York, 10017, United States
Apex Eye Clinical Research, LLC
Mason, Ohio, 45040, United States
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112, United States
Vanderbilt Eye Institute
Nashville, Tennessee, 37232, United States
Glaucoma Associates of Texas
Dallas, Texas, 75231, United States
El Paso Eye Surgeons
El Paso, Texas, 79922, United States
Ophthalmology Associates
Fort Worth, Texas, 76102, United States
Houston Eye Associates
Houston, Texas, 77025, United States
Berkeley Eye Center
Houston, Texas, 77027, United States
R and R Eye Research
San Antonio, Texas, 78229, United States
The Eye Institute of Utah
Salt Lake City, Utah, 84107, United States
Spokane Eye Clinical Research
Spokane, Washington, 99204, United States
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142, United States
Prism Eye Institute
Oakville, Ontario, L6H 0J8, Canada
The Institute de l'Oeil des Laurentides
Boisbriand, Quebec, J7N0C2, 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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Sabine Glibert
iSTAR Medical
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Masking Details
- Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2021
First Posted
August 27, 2021
Study Start
August 19, 2021
Primary Completion (Estimated)
July 1, 2027
Study Completion (Estimated)
July 1, 2029
Last Updated
September 12, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share