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Trial record 2 of 17 for:    iStar
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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

Tracking Information
First Submitted Date  ICMJE August 23, 2021
First Posted Date  ICMJE August 27, 2021
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE August 19, 2021
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2021)
  • Intraocular pressure decrease [ Time Frame: 24 months ]
    Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated DIOP at Month 24.
  • Intraocular pressure decrease (outcome 2) [ Time Frame: 24 months ]
    Change from baseline in mean unmedicated diurnal IOP at Month 24.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
Official Title  ICMJE A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Glaucoma
Intervention  ICMJE 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.
Study Arms  ICMJE Experimental: Implant Group
Intervention: Device: MINIject™ Implant
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 23, 2021)		 975
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2027
Estimated Primary Completion Date March 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 46 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Abhi Vilupuru, Ph.D 714-914-5527 abhi.vilupuru@istarmed.us
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05024695
Other Study ID Numbers  ICMJE ISM06
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party iSTAR Medical
Original Responsible Party Same as current
Current Study Sponsor  ICMJE iSTAR Medical
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Abhi Vilupuru, Ph.D iSTAR Medical
PRS Account iSTAR Medical
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP