Evaluating a new implant for lowering eye pressure in glaucoma patients
A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
This study is testing a new implant to see if it can safely lower eye pressure in people with glaucoma better than the usual treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 975 (estimated) |
| Ages | 46 Years and up |
| Sex | All |
| Sponsor | iSTAR Medical Industry-sponsored |
| Locations | 37 sites (Glendale, Arizona and 36 other locations) |
| Trial ID | NCT05024695 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the safety and effectiveness of the MINIject™ implant developed by iSTAR Medical for reducing intraocular pressure (IOP) in individuals diagnosed with primary open-angle glaucoma. It is a prospective, multicenter, masked trial that involves multiple research sites. Participants will be monitored to determine how well the implant performs compared to standard treatments for managing glaucoma.
Who should consider this trial
Good fit: Ideal candidates for this study are males and females aged 46 and older with a diagnosis of primary open-angle glaucoma who are suitable for medical therapy, laser treatment, or glaucoma-filtering surgery.
Not a fit: Patients with angle closure, congenital, or secondary glaucoma, as well as those with significant visual disorders or intraocular inflammation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this implant could provide a new, effective treatment option for patients with primary open-angle glaucoma, potentially improving their quality of life.
How similar studies have performed: Other studies have shown promise with similar minimally invasive glaucoma surgeries (MIGS), indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Glendale, Arizona and 36 other locations
- Arizona Advanced Eye Research Institute — Glendale, Arizona, United States (Recruiting)
- Vold Vision — Fayetteville, Arkansas, United States (Terminated)
- Beverly Hills Institute of Ophthalmology — Beverly Hills, California, United States (Recruiting)
- Reeve Woods Eye Center — Chico, California, United States (Recruiting)
- Sacramento Eye Consultants, A Medical Corporation — Sacramento, California, United States (Recruiting)
- Grand Junction Eye Care — Grand Junction, Colorado, United States (Terminated)
- Eye Associates of Fort Myers — Fort Myers, Florida, United States (Recruiting)
- Intermountain Eye Center — Eagle, Idaho, United States (Recruiting)
- Illinois Eye Center — Peoria, Illinois, United States (Recruiting)
- Virdi Eye Clinic — Rock Island, Illinois, United States (Recruiting)
- Stiles Eyecare Excellene and Glaucoma Institute — Overland Park, Kansas, United States (Recruiting)
- LA Eye and Laser — Alexandria, Louisiana, United States (Recruiting)
- Minnesota Eye Consultants — Bloomington, Minnesota, United States (Recruiting)
- Eye Consultants PC — Omaha, Nebraska, United States (Recruiting)
- Center for Sight Las Vegas — Las Vegas, Nevada, United States (Recruiting)
- NYU Langone Ophthalmology — New York, New York, United States (Recruiting)
- Apex Eye Clinical Research, LLC — Mason, Ohio, United States (Active_not_recruiting)
- Oklahoma Eye Surgeons — Oklahoma City, Oklahoma, United States (Recruiting)
- Vanderbilt Eye Institute — Nashville, Tennessee, United States (Active_not_recruiting)
- Glaucoma Associates of Texas — Dallas, Texas, United States (Recruiting)
- El Paso Eye Surgeons — El Paso, Texas, United States (Recruiting)
- Ophthalmology Associates — Fort Worth, Texas, United States (Recruiting)
- Houston Eye Associates — Houston, Texas, United States (Recruiting)
- Berkeley Eye Center — Houston, Texas, United States (Recruiting)
- R and R Eye Research — San Antonio, Texas, United States (Recruiting)
- The Eye Institute of Utah — Salt Lake City, Utah, United States (Recruiting)
- Spokane Eye Clinical Research — Spokane, Washington, United States (Recruiting)
- Eye Centers of Racine and Kenosha — Kenosha, Wisconsin, United States (Recruiting)
- Prism Eye Institute — Oakville, Ontario, Canada (Active_not_recruiting)
- The Institute de l'Oeil des Laurentides — Boisbriand, Quebec, Canada (Active_not_recruiting)
- Clinique Opthalmologies Bellevue — Montréal, Canada (Active_not_recruiting)
- Swiss Glaucoma Research Foundation Swiss Visio Montchoisi — Lausanne, Switzerland (Recruiting)
- Queen Victoria Hospital NHS Foundation Trust — East Grinstead, United Kingdom (Recruiting)
- Glaucoma Service Moorfields Eye Hospital — London, United Kingdom (Recruiting)
- Imperial College Healthcare NHS Trust Western Eye Hospital — London, United Kingdom (Recruiting)
- KCL Frost Eye Research Department St Thomas' Hospital — London, United Kingdom (Recruiting)
- Research & Development Unit, Learning and Research Centre (LaRC), York Hospital — York, United Kingdom (Active_not_recruiting)
Study contacts
- Study coordinator: Joanna Walker
- Email: joanna.walker@istar-medical.com
- Phone: +32 10 77 16 54
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.