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Clinical Trials/NCT05024695
NCT05024695
Active, not recruiting
Not Applicable

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

iSTAR Medical37 sites in 4 countries975 target enrollmentAugust 19, 2021
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ConditionsGlaucoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Glaucoma
Sponsor
iSTAR Medical
Enrollment
975
Locations
37
Primary Endpoint
Intraocular pressure decrease
Status
Active, not recruiting
Last Updated
7 months ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 19, 2021
End Date
July 1, 2029
Last Updated
7 months ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Exclusion Criteria

  • •Angle closure, congenital, or secondary glaucoma
  • •Diagnosed degenerative visual disorders
  • •Clinically significant intraocular inflammation or infection

Outcomes

Primary Outcomes

Intraocular pressure decrease

Time Frame: 24 months

Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.

Intraocular pressure decrease (outcome 2)

Time Frame: 24 months

Change from baseline in mean unmedicated diurnal IOP at Month 24.

Study Sites (37)

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