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)

September 7, 2025 updated by: iSTAR Medical

A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

975

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
      • Montreal, Canada
        • Clinique Opthalmologies Bellevue
    • Ontario
      • Oakville, Ontario, Canada, L6H 0J8
        • Prism Eye Institute
    • Quebec
      • Boisbriand, Quebec, Canada, J7N0C2
        • The Institute de l'Oeil des Laurentides
  • Switzerland
      • Lausanne, Switzerland
        • Swiss Glaucoma Research Foundation Swiss Visio Montchoisi
  • United Kingdom
      • East Grinstead, United Kingdom
        • Queen Victoria Hospital NHS Foundation Trust
      • London, 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
      • York, United Kingdom
        • Research & Development Unit, Learning and Research Centre (LaRC), York Hospital
  • United States
    • Arizona
      • Glendale, Arizona, United States, 85306
        • Arizona Advanced Eye Research Institute
    • Arkansas
      • Fayetteville, Arkansas, United States, 72704
        • Vold Vision
    • California
      • Beverly Hills, California, United States, 90210
        • Beverly Hills Institute of Ophthalmology
      • Chico, California, United States, 95926
        • Reeve Woods Eye Center
      • Sacramento, California, United States, 95815
        • Sacramento Eye Consultants, A Medical Corporation
    • Colorado
      • Grand Junction, Colorado, United States, 81501
        • Grand Junction Eye Care
    • Florida
      • Fort Myers, Florida, United States, 33901
        • Eye Associates of Fort Myers
    • Idaho
      • Eagle, Idaho, United States, 83616
        • Intermountain Eye Center
    • Illinois
      • Peoria, Illinois, United States, 61615
        • Illinois Eye Center
      • Rock Island, Illinois, United States, 61201
        • Virdi Eye Clinic
    • Kansas
      • Overland Park, Kansas, United States, 66213
        • Stiles Eyecare Excellene and Glaucoma Institute
    • Louisiana
      • Alexandria, Louisiana, United States, 71303
        • LA Eye and Laser
    • Minnesota
      • Bloomington, Minnesota, United States, 55431
        • Minnesota Eye Consultants
    • Nebraska
      • Omaha, Nebraska, United States, 68124
        • Eye Consultants PC
    • Nevada
      • Las Vegas, Nevada, United States, 89145
        • Center for Sight Las Vegas
    • New York
      • New York, New York, United States, 10017
        • NYU Langone Ophthalmology
    • Ohio
      • Mason, Ohio, United States, 45040
        • Apex Eye Clinical Research, LLC
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Oklahoma Eye Surgeons
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt Eye Institute
    • Texas
      • Dallas, Texas, United States, 75231
        • Glaucoma Associates of Texas
      • El Paso, Texas, United States, 79922
        • El Paso Eye Surgeons
      • Fort Worth, Texas, United States, 76102
        • Ophthalmology Associates
      • Houston, Texas, United States, 77027
        • Berkeley Eye Center
      • Houston, Texas, United States, 77025
        • Houston Eye Associates
      • San Antonio, Texas, United States, 78229
        • R and R Eye Research
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • The Eye Institute of Utah
    • Washington
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinical Research
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53142
        • Eye Centers of Racine and Kenosha

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

42 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Implant Group
Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraocular pressure decrease (outcome 2)
Time Frame: 24 months
Change from baseline in mean unmedicated diurnal IOP at Month 24.
24 months
Intraocular pressure decrease
Time Frame: 24 months
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

iSTAR Medical

Investigators

  • Study Director: Sabine Glibert, iSTAR Medical

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2021

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

July 1, 2029

Study Registration Dates

First Submitted

August 23, 2021

First Submitted That Met QC Criteria

August 23, 2021

First Posted (Actual)

August 27, 2021

Study Record Updates

Last Update Posted (Estimated)

September 12, 2025

Last Update Submitted That Met QC Criteria

September 7, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ISM06 (STAR-V)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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