MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Overview

The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Full Title of Study: “A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: May 16, 2022

Detailed Description

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery. The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Interventions

  • Device: MINIject CS627 implant
    • MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.

Arms, Groups and Cohorts

  • Experimental: MINIject CS627 implant
    • MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.

Clinical Trial Outcome Measures

Primary Measures

  • Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
    • Time Frame: 6 month post surgey
    • The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.

Participating in This Clinical Trial

Inclusion Criteria

  • Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier. – Grade 3 or grade 4 according to Shaffer Angle Grading System. – Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit. Exclusion Criteria:

  • Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye. – Neovascular glaucoma in the study eye. – Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye. – Prior glaucoma surgery in the study eye.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • iSTAR Medical
  • Collaborator
    • International Drug Development Institute
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Zubair Hussain, PhD, Study Director, iSTAR

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