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NCT05024695 Clinical Trial

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

Glaucoma Clinical Trial

— STAR-V  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05024695
Other study ID # ISM06
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 19, 2021
Est. completion date March 2027

Study information
Verified date August 2021
Source iSTAR Medical
Contact Abhi Vilupuru, Ph.D
Phone 714-914-5527
Email abhi.vilupuru@istarmed.us
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 975
Est. completion date March 2027
Est. primary completion date March 2025
Accepts healthy volunteers No
Gender All
Age group 46 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• MINIject™ 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.

Locations
Country Name City State
United States Vold Vision Fayetteville Arkansas

Sponsors (1)
Lead Sponsor Collaborator
iSTAR Medical

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Intraocular pressure decrease Proportion of subjects with = 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24. 24 months
Primary Intraocular pressure decrease (outcome 2) Change from baseline in mean unmedicated diurnal IOP at Month 24. 24 months
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