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

Not Applicable

Active, not recruiting

• Conditions: Glaucoma

• Registration Number: NCT05024695
• Lead Sponsor: iSTAR Medical

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.

Study Timeline

• Study Start: 2021-08-19
• Study First Submitted: 2021-08-23
• Study First Submitted QC: 2021-08-23
• Study First Posted: 2021-08-27
• Status Verified: 2025-06
• Last Update Submitted: 2025-09-07
• Last Update Posted: 2025-09-12
• Primary Completion: 2027-07
• Study Completion: 2029-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 975

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Intraocular pressure decrease	24 months	Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
Intraocular pressure decrease (outcome 2)	24 months	Change from baseline in mean unmedicated diurnal IOP at Month 24.

Trial Locations

Locations (37)

Arizona Advanced Eye Research Institute; 🇺🇸 Glendale, Arizona, United States

Vold Vision; 🇺🇸 Fayetteville, Arkansas, United States

Beverly Hills Institute of Ophthalmology; 🇺🇸 Beverly Hills, California, United States

Reeve Woods Eye Center; 🇺🇸 Chico, California, United States

Sacramento Eye Consultants, A Medical Corporation; 🇺🇸 Sacramento, California, United States

Grand Junction Eye Care; 🇺🇸 Grand Junction, Colorado, United States

Eye Associates of Fort Myers; 🇺🇸 Fort Myers, Florida, United States

Intermountain Eye Center; 🇺🇸 Eagle, Idaho, United States

Illinois Eye Center; 🇺🇸 Peoria, Illinois, United States

Virdi Eye Clinic; 🇺🇸 Rock Island, Illinois, United States

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