ClinicalTrials.gov
History of Changes for Study: NCT05024695
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)
Latest version (submitted August 23, 2021) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 August 23, 2021 None (earliest Version on record)
Comparison Format:
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Study NCT05024695
Submitted Date:  August 23, 2021 (v1)
Open or close this module Study Identification
Unique Protocol ID: ISM06
Brief Title: 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)
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
Secondary IDs:
Open or close this module Study Status
Record Verification: August 2021
Overall Status: Recruiting
Study Start: August 19, 2021
Primary Completion: March 2025 [Anticipated]
Study Completion: March 2027 [Anticipated]
First Submitted: August 23, 2021
First Submitted that
Met QC Criteria:		 August 23, 2021
First Posted: August 27, 2021 [Actual]
Last Update Submitted that
Met QC Criteria:		 August 23, 2021
Last Update Posted: August 27, 2021 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: iSTAR Medical
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: Yes
Unapproved/Uncleared Device: Yes
Pediatric Postmarket Surveillance:
Data Monitoring: No
Open or close this module Study Description
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.
Open or close this module Conditions
Conditions: Glaucoma
Keywords: glaucoma
MIGS
primary open angle glaucoma
suprachoroidal space
supraciliary space
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Not Applicable
Interventional Study Model: Single Group Assignment
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.
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 975 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: Implant Group 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.
Open or close this module Outcome Measures
Primary Outcome Measures:
1. Intraocular pressure decrease
[ Time Frame: 24 months ]

Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24.
2. Intraocular pressure decrease (outcome 2)
[ Time Frame: 24 months ]

Change from baseline in mean unmedicated diurnal IOP at Month 24.
Open or close this module Eligibility
Minimum Age: 46 Years
Maximum Age:
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
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
Open or close this module Contacts/Locations
Central Contact Person: Abhi Vilupuru, Ph.D
Telephone: 714-914-5527
Email: abhi.vilupuru@istarmed.us
Study Officials: Abhi Vilupuru, Ph.D
Study Chair
iSTAR Medical
Locations: United States, Arkansas
Vold Vision
[Recruiting]
Fayetteville, Arkansas, United States, 72704
Contact:Contact: Steve Vold
Contact:Principal Investigator: Steve Vold, M.D.
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
Citations:
Links:
Available IPD/Information:
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U.S. National Library of Medicine | U.S. National Institutes of Health | U.S. Department of Health & Human Services