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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. (STAR-V)

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ClinicalTrials.gov Identifier: NCT05024695
Recruitment Status : Recruiting
First Posted : August 27, 2021
Last Update Posted : August 27, 2021
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

Study Description
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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.

Condition or disease Intervention/treatment Phase
Glaucoma Device: MINIject™ Implant Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 975 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Intervention 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.
Primary Purpose: Treatment
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
Actual Study Start Date : August 19, 2021
Estimated Primary Completion Date : March 2025
Estimated Study Completion Date : March 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arms and Interventions
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Arm Intervention/treatment
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.


Outcome Measures
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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.


Eligibility Criteria
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Ages Eligible for Study:   46 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05024695


Contacts
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Contact: Abhi Vilupuru, Ph.D 714-914-5527 abhi.vilupuru@istarmed.us

Locations
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United States, Arkansas
Vold Vision Recruiting
Fayetteville, Arkansas, United States, 72704
Contact: Steve Vold         
Principal Investigator: Steve Vold, M.D.         
Sponsors and Collaborators
iSTAR Medical
Investigators
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Study Chair: Abhi Vilupuru, Ph.D iSTAR Medical
More Information
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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT05024695    
Other Study ID Numbers: ISM06
First Posted: August 27, 2021    Key Record Dates
Last Update Posted: August 27, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by iSTAR Medical:
glaucoma
MIGS
primary open angle glaucoma
suprachoroidal space
supraciliary space
Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases