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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Glaucoma

Intervention / Treatment
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* Device: MINIject™ Implant


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 46 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 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. The MINIject™ SO627 implant is manufactured from proprietary STAR® silicone material.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implant Group<br> | Device: MINIject™ Implant<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular pressure decrease | Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24. | 24 months | 
| Intraocular pressure decrease (outcome 2) | Change from baseline in mean unmedicated diurnal IOP at Month 24. | 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space