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NCT Number: NCT05024695

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Glaucoma Choroid Diseases Choroidal Effusions Eye Abnormalities Eye Diseases Glaucoma, Open-Angle Ocular Hypertension Uveal Diseases

Age range

46 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Prism Eye Institute, Oakville, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MINIject™ Implant

Device

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.

Primary outcomes

  1. Intraocular pressure decrease

    Time frame: 24 months

    Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.

  2. Intraocular pressure decrease (outcome 2)

    Time frame: 24 months

    Change from baseline in mean unmedicated diurnal IOP at Month 24.

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

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

Acronym: STAR-V

Important dates

Study start
2021
Primary completion
2027
Study completion
2029
First posted
Aug 27, 2021
Registry last updated
Sep 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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