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 UK 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

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)

Facility	City	Region
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

More iSTAR Medical trials in the UK

MINIject Implantation Combined With Cataract Surgery in Patients With POAG and Cataract Enrolling by invitation

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma Recruiting

STAR-LIFE: a Post-market Registry on MINIject Active, not recruiting

Other trials for the same condition

A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma 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 UK