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

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05024695

Acronym

STAR-V

Enrollment

975

Registered

2021-08-27

Start date

2021-08-19

Completion date

2029-07-31

Last updated

2025-09-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma

Keywords

glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space

Brief summary

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

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.

Interventions

DEVICEMINIject™ 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 design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Masking description

Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.

Eligibility

Sex/Gender

ALL

Age

46 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
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.

Countries

Canada, Switzerland, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026