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

Last updated: September 7, 2025
Sponsor: iSTAR Medical
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Glaucoma

Treatment

MINIject™ Implant

Clinical Study ID

NCT05024695
ISM06 (STAR-V)
  • Ages > 46
  • All Genders

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 Criteria

Inclusion

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

Exclusion

Key Exclusion Criteria:

  • Angle closure, congenital, or secondary glaucoma

  • Diagnosed degenerative visual disorders

  • Clinically significant intraocular inflammation or infection

Study Design

Total Participants: 975
Treatment Group(s): 1
Primary Treatment: MINIject™ Implant
Phase:
Study Start date:
August 19, 2021
Estimated Completion Date:
July 31, 2029

Study 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.

Connect with a study center

  • Prism Eye Institute

    Oakville, Ontario L6H 0J8
    Canada

    Site Not Available

  • Prism Eye Institute

    Oakville 6092122, Ontario 6093943 L6H 0J8
    Canada

    Site Not Available

  • The Institute de l'Oeil des Laurentides

    Boisbriand, Quebec J7N0C2
    Canada

    Site Not Available

  • The Institute de l'Oeil des Laurentides

    Boisbriand 5905132, Quebec 6115047 J7N0C2
    Canada

    Site Not Available

  • Clinique Opthalmologies Bellevue

    Montreal 6077243,
    Canada

    Site Not Available

  • Clinique Opthalmologies Bellevue

    Montréal,
    Canada

    Site Not Available

  • Swiss Glaucoma Research Foundation Swiss Visio Montchoisi

    Lausanne,
    Switzerland

    Site Not Available

  • Swiss Glaucoma Research Foundation Swiss Visio Montchoisi

    Lausanne 2659994,
    Switzerland

    Site Not Available

  • Queen Victoria Hospital NHS Foundation Trust

    East Grinstead,
    United Kingdom

    Site Not Available

  • Queen Victoria Hospital NHS Foundation Trust

    East Grinstead 2650435,
    United Kingdom

    Site Not Available

  • Glaucoma Service Moorfields Eye Hospital

    London,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust Western Eye Hospital

    London,
    United Kingdom

    Active - Recruiting

  • KCL Frost Eye Research Department St Thomas' Hospital

    London,
    United Kingdom

    Active - Recruiting

  • Glaucoma Service Moorfields Eye Hospital

    London 2643743,
    United Kingdom

    Site Not Available

  • Imperial College Healthcare NHS Trust Western Eye Hospital

    London 2643743,
    United Kingdom

    Site Not Available

  • KCL Frost Eye Research Department St Thomas' Hospital

    London 2643743,
    United Kingdom

    Site Not Available

  • Research & Development Unit, Learning and Research Centre (LaRC), York Hospital

    York,
    United Kingdom

    Site Not Available

  • Research & Development Unit, Learning and Research Centre (LaRC), York Hospital

    York 2633352,
    United Kingdom

    Site Not Available

  • Arizona Advanced Eye Research Institute

    Glendale, Arizona 85306
    United States

    Site Not Available

  • Arizona Advanced Eye Research Institute

    Glendale 5295985, Arizona 5551752 85306
    United States

    Site Not Available

  • Vold Vision

    Fayetteville, Arkansas 72704
    United States

    Site Not Available

  • Vold Vision

    Fayetteville 4110486, Arkansas 4099753 72704
    United States

    Site Not Available

  • Beverly Hills Institute of Ophthalmology

    Beverly Hills, California 90210
    United States

    Site Not Available

  • Reeve Woods Eye Center

    Chico, California 95926
    United States

    Site Not Available

  • Sacramento Eye Consultants, A Medical Corporation

    Sacramento, California 95815
    United States

    Site Not Available

  • Beverly Hills Institute of Ophthalmology

    Beverly Hills 5328041, California 5332921 90210
    United States

    Site Not Available

  • Reeve Woods Eye Center

    Chico 5336269, California 5332921 95926
    United States

    Site Not Available

  • Sacramento Eye Consultants, A Medical Corporation

    Sacramento 5389489, California 5332921 95815
    United States

    Site Not Available

  • Grand Junction Eye Care

    Grand Junction, Colorado 81501
    United States

    Site Not Available

  • Grand Junction Eye Care

    Grand Junction 5423573, Colorado 5417618 81501
    United States

    Site Not Available

  • Eye Associates of Fort Myers

    Fort Myers, Florida 33901
    United States

    Site Not Available

  • Eye Associates of Fort Myers

    Fort Myers 4155995, Florida 4155751 33901
    United States

    Site Not Available

  • Intermountain Eye Center

    Eagle, Idaho 83616
    United States

    Site Not Available

  • Intermountain Eye Center

    Eagle 5591778, Idaho 5596512 83616
    United States

    Site Not Available

  • Illinois Eye Center

    Peoria, Illinois 61615
    United States

    Site Not Available

  • Virdi Eye Clinic

    Rock Island, Illinois 61201
    United States

    Site Not Available

  • Illinois Eye Center

    Peoria 4905687, Illinois 4896861 61615
    United States

    Site Not Available

  • Virdi Eye Clinic

    Rock Island 4907907, Illinois 4896861 61201
    United States

    Site Not Available

  • Stiles Eyecare Excellene and Glaucoma Institute

    Overland Park, Kansas 66213
    United States

    Site Not Available

  • Stiles Eyecare Excellene and Glaucoma Institute

    Overland Park 4276873, Kansas 4273857 66213
    United States

    Site Not Available

  • LA Eye and Laser

    Alexandria, Louisiana 71303
    United States

    Site Not Available

  • LA Eye and Laser

    Alexandria 4314550, Louisiana 4331987 71303
    United States

    Site Not Available

  • Minnesota Eye Consultants

    Bloomington, Minnesota 55431
    United States

    Site Not Available

  • Minnesota Eye Consultants

    Bloomington 5018739, Minnesota 5037779 55431
    United States

    Site Not Available

  • Eye Consultants PC

    Omaha, Nebraska 68124
    United States

    Site Not Available

  • Eye Consultants PC

    Omaha 5074472, Nebraska 5073708 68124
    United States

    Site Not Available

  • Center for Sight Las Vegas

    Las Vegas, Nevada 89145
    United States

    Site Not Available

  • Center for Sight Las Vegas

    Las Vegas 5506956, Nevada 5509151 89145
    United States

    Site Not Available

  • NYU Langone Ophthalmology

    New York, New York 10017
    United States

    Site Not Available

  • NYU Langone Ophthalmology

    New York 5128581, New York 5128638 10017
    United States

    Site Not Available

  • Apex Eye Clinical Research, LLC

    Mason, Ohio 45040
    United States

    Site Not Available

  • Apex Eye Clinical Research, LLC

    Mason 4517698, Ohio 5165418 45040
    United States

    Site Not Available

  • Oklahoma Eye Surgeons

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Oklahoma Eye Surgeons

    Oklahoma City 4544349, Oklahoma 4544379 73112
    United States

    Site Not Available

  • Vanderbilt Eye Institute

    Nashville, Tennessee 37232
    United States

    Site Not Available

  • Vanderbilt Eye Institute

    Nashville 4644585, Tennessee 4662168 37232
    United States

    Site Not Available

  • Glaucoma Associates of Texas

    Dallas, Texas 75231
    United States

    Site Not Available

  • El Paso Eye Surgeons

    El Paso, Texas 79922
    United States

    Site Not Available

  • Ophthalmology Associates

    Fort Worth, Texas 76102
    United States

    Site Not Available

  • Berkeley Eye Center

    Houston, Texas 77027
    United States

    Site Not Available

  • Houston Eye Associates

    Houston, Texas 77025
    United States

    Active - Recruiting

  • R and R Eye Research

    San Antonio, Texas 78229
    United States

    Site Not Available

  • Glaucoma Associates of Texas

    Dallas 4684888, Texas 4736286 75231
    United States

    Site Not Available

  • El Paso Eye Surgeons

    El Paso 5520993, Texas 4736286 79922
    United States

    Site Not Available

  • Ophthalmology Associates

    Fort Worth 4691930, Texas 4736286 76102
    United States

    Site Not Available

  • Berkeley Eye Center

    Houston 4699066, Texas 4736286 77027
    United States

    Site Not Available

  • Houston Eye Associates

    Houston 4699066, Texas 4736286 77025
    United States

    Site Not Available

  • R and R Eye Research

    San Antonio 4726206, Texas 4736286 78229
    United States

    Site Not Available

  • The Eye Institute of Utah

    Salt Lake City, Utah 84107
    United States

    Site Not Available

  • The Eye Institute of Utah

    Salt Lake City 5780993, Utah 5549030 84107
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Site Not Available

  • Spokane Eye Clinical Research

    Spokane 5811696, Washington 5815135 99204
    United States

    Site Not Available

  • Eye Centers of Racine and Kenosha

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

  • Eye Centers of Racine and Kenosha

    Kenosha 5258393, Wisconsin 5279468 53142
    United States

    Site Not Available

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