Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
- Conditions
- Glaucoma
- Interventions
- Device: MINIject™ Implant
- Registration Number
- NCT05024695
- Lead Sponsor
- iSTAR Medical
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 975
- 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
- Angle closure, congenital, or secondary glaucoma
- Diagnosed degenerative visual disorders
- Clinically significant intraocular inflammation or infection
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Implant Group MINIject™ Implant -
- Primary Outcome Measures
Name Time Method Intraocular pressure decrease 24 months Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
Intraocular pressure decrease (outcome 2) 24 months Change from baseline in mean unmedicated diurnal IOP at Month 24.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (37)
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
🇨🇦Montréal, 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
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
Research & Development Unit, Learning and Research Centre (LaRC), York Hospital
🇬🇧York, United Kingdom