Back to resultsEvaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma. (STAR-V)
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MINIject™ Implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma focused on measuring glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space
Eligibility 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
Sites / Locations
- Vold VisionRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Implant Group
Arm Description
Outcomes
Primary Outcome Measures
Intraocular pressure decrease
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24.
Intraocular pressure decrease (outcome 2)
Change from baseline in mean unmedicated diurnal IOP at Month 24.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05024695
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.
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2021
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2021 (Actual)
Primary Completion Date
March 2025 (Anticipated)
Study Completion Date
March 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iSTAR Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
Keywords
glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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)
Masking Description
Person(s) checking intraocular pressures are masked, except for day of surgery, throughout the duration of the trial.
Allocation
N/A
Enrollment
975 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Implant Group
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
MINIject™ Implant
Intervention 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.
Primary Outcome Measure Information:
Title
Intraocular pressure decrease
Description
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24.
Time Frame
24 months
Title
Intraocular pressure decrease (outcome 2)
Description
Change from baseline in mean unmedicated diurnal IOP at Month 24.
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
46 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Abhi Vilupuru, Ph.D
Phone
714-914-5527
Email
abhi.vilupuru@istarmed.us
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abhi Vilupuru, Ph.D
Organizational Affiliation
iSTAR Medical
Official's Role
Study Chair
Facility Information:
Facility Name
Vold Vision
City
Fayetteville
State/Province
Arkansas
ZIP/Postal Code
72704
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Steve Vold
First Name & Middle Initial & Last Name & Degree
Steve Vold, M.D.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
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