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)

iSTAR Medical

Status: Active, not recruiting

Conditions: Glaucoma

Treatments: Device: MINIject™ Implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05024695

ISM06

Details and patient eligibility

About

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

Full 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.

Enrollment: 975 estimated patients

Sex: All

Ages: 46+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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975 participants in 1 patient group

Implant Group

Experimental group

Treatment:

Device: MINIject™ Implant