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Clinical Trials in the USA / NCT05024695
Active, not recruiting Not applicable

Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.

NCT05024695 · tracked via the Priya Life Science USA tracker
Sponsor
iSTAR Medical
Phase
Not applicable
Started
2021-08-19
Last updated
2025-09-12

Condition(s) studied

Glaucoma

Investigational drug(s) / intervention(s)

MINIject™ Implant

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.

Study summary

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

Eligibility

Sex
ALL
Min age
46 Years
Max age
—
Healthy volunteers
No
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 outcome measure(s)

  • 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.

Trial sites (37)

FacilityCityRegionStatus
Arizona Advanced Eye Research Institute Glendale Arizona
Vold Vision Fayetteville Arkansas
Beverly Hills Institute of Ophthalmology Beverly Hills California
Reeve Woods Eye Center Chico California
Sacramento Eye Consultants, A Medical Corporation Sacramento California
Grand Junction Eye Care Grand Junction Colorado
Eye Associates of Fort Myers Fort Myers Florida
Intermountain Eye Center Eagle Idaho
Illinois Eye Center Peoria Illinois
Virdi Eye Clinic Rock Island Illinois
Stiles Eyecare Excellene and Glaucoma Institute Overland Park Kansas
LA Eye and Laser Alexandria Louisiana
Minnesota Eye Consultants Bloomington Minnesota
Eye Consultants PC Omaha Nebraska
Center for Sight Las Vegas Las Vegas Nevada
NYU Langone Ophthalmology New York New York
Apex Eye Clinical Research, LLC Mason Ohio
Oklahoma Eye Surgeons Oklahoma City Oklahoma
Vanderbilt Eye Institute Nashville Tennessee
Glaucoma Associates of Texas Dallas Texas
El Paso Eye Surgeons El Paso Texas
Ophthalmology Associates Fort Worth Texas
Houston Eye Associates Houston Texas
Berkeley Eye Center Houston Texas
R and R Eye Research San Antonio Texas
The Eye Institute of Utah Salt Lake City Utah
Spokane Eye Clinical Research Spokane Washington
Eye Centers of Racine and Kenosha Kenosha Wisconsin
Prism Eye Institute Oakville Ontario
The Institute de l'Oeil des Laurentides Boisbriand Quebec
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

Other trials for the same condition

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Comparative Study of the Tomey FT-1000, and Goldmann Applanation Tonometer (GAT) Recruiting
Phase 2 Trial to Evaluate the Safety and Efficacy of the Second Generation Travoprost Intracameral Implant Recruiting
Visual Field Analysis With Artificial Intelligence Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05024695 on ClinicalTrials.gov ↗ ← All trials in the USA