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

Sponsor
iSTAR Medical
Study ID
NCT07009236
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
20 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MIGS — DEVICE
    Implant MINIject S+ in supraciliary space

Study Details

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).

Key Dates

First listed
Jun 6, 2025
Start date
Sep 29, 2025
Status verified
Jun 2026
Primary completion
Aug 31, 2026
Completion
Jul 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Investigational device FG300X
    One version of delivery tool
  • Active Comparator: Investigational device FG300Y
    One version of delivery tool
  • Active Comparator: Investigational device FG300Z
    One version of delivery tool

Primary Outcome Measure

Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader [ Time Frame: 1 week ]

Central Contacts

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