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A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma

Study acronym: STAR VII
StatusRecruiting
PhaseNot applicable
Started
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Record status
This record was last updated June 10, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Trial status: Not Yet Recruiting to Recruitingv2 Show 7 more changesShow less
    • Enrollment target: 30 to 60
    • Primary completion date: Dec 2027 to Aug 2026
    • Primary endpoints: 1 to 2
    • Study sites: 3 to 5
    • Study completion date: Mar 2028 to Jul 2028
    • Start date changed from estimate of Jul 2025 to Sep 29, 2025
    • Secondary endpoints expanded, about 116 words
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
Trial Details
NCT Number NCT07009236
Lead Sponsor iSTAR Medical
Conditions
(from sponsor)		 Glaucoma
Related terms Glaucoma
Enrollment 60 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov