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The trial is taking place at:
B

Beverly Hills Institute of Ophthalmology | Beverly Hills, CA

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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)

I

iSTAR Medical

Status

Active, not recruiting

Conditions

Glaucoma

Treatments

Device: MINIject™ Implant

Study type

Interventional

Funder types

Industry

Identifiers

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)

975 participants in 1 patient group

Implant Group
Experimental group
Treatment:
Device: MINIject™ Implant

Trial contacts and locations

27

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Central trial contact

Abhi Vilupuru, Ph.D

Data sourced from clinicaltrials.gov

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