MINIject Global Long-Term Follow-up Study (STAR-GLOBAL)

A Prospective, Open, Multicentre Study Analysing the Long-term Safety of MINIject Glaucoma Implants in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Study Overview

• Status: Recruiting
• Conditions: Ocular Hypertension; Open Angle Glaucoma
• Intervention / Treatment: Device: Minimally invasive glaucoma surgery (MIGS)

Detailed Description

The study aims to assess long-term safety and performance of MINIject glaucoma implant up to 5 years post-implantation. Patients who received implant and were followed for 2 years in a previous study, will be invited to continue long-term follow-up from 2 to 5 years post-implantation at annual intervals. Standard ophthalmologic assessments including measurement of intraocular pressure, fundus examination, ocular imaging, assessment of any untoward ocular events etc. will be performed.

• Study Type: Observational
• Enrollment (Anticipated): 300

Contacts and Locations

• Study Contact: Name: Esma Islamaj, PhD; Phone Number: +32 10 77 12 52; Email: esma.islamaj@istarmed.com
• Study Contact Backup: Name: Pascale Ducloux; Email: pascale.ducloux@istarmed.com

Study Locations

• Colombia
  • Barranquilla, Colombia
    • Recruiting
    • Clínica Oftalmológica del Caribe
    • Contact: Jose Luis Rodriguez, MD
    • Principal Investigator: Jose Luis Rodriguez, MD
    • Principal Investigator: Andrea Vasquez, MD
• France
  • Grenoble, France, 38043
    • Active, not recruiting
    • Center Hospotalier Universitaire Genoble Alpes
  • Lyon, France, 69417
    • Active, not recruiting
    • Hopital de la Croix-Rousse
• Germany
  • München, Germany, 81377
    • Recruiting
    • Klinikum der Universität München
    • Contact: Marc Mackert, MD.
  • Nordrhein-Westfalen
    • Köln, Nordrhein-Westfalen, Germany, 50937
      • Active, not recruiting
      • Uniklinik Köln
  • Rheinland Pfalz
    • Mainz, Rheinland Pfalz, Germany, 55131
      • Active, not recruiting
      • Universitätsklinikum Mainz
• India
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Recruiting
      • Maxivision Eye Hospital
      • Contact: Anitha Kamarthy, MD
      • Principal Investigator: Kasu Prasad Reddy, MD
• Panama
  • Panama City, Panama
    • Active, not recruiting
    • Panama Eye Center
• Spain
  • Madrid, Spain
    • Active, not recruiting
    • Hospital Clinico San Carlos

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study

Description

Inclusion Criteria:

• Patient who received a MINIject glaucoma implant within a prior clinical study
• Patient continues to have MINIject implanted at the point of enrolment
• Patient must provide written informed consent to participate

Exclusion Criteria:

• Individuals under tutorship or trusteeship
• Patient who is unwilling to return to the study visits and undergo study assessments, as required by clinical study protocol

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients with serious device-related adverse event in study eye	The proportion of patients with at least one serious ocular adverse event in the study eye, related to the device, occurring between 2 and 5 years after the MINIject implantation.	5 years post-implantation

Collaborators and Investigators

• Sponsor: iSTAR Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2020
• Primary Completion (Anticipated): December 1, 2025
• Study Completion (Anticipated): December 1, 2025

Study Registration Dates

• First Submitted: August 20, 2020
• First Submitted That Met QC Criteria: August 20, 2020
• First Posted (Actual): August 24, 2020

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: May 2, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Ocular hypertension; Open Angle Glaucoma; Glaucoma Drainage Device; Intra Ocular Pressure (IOP) reduction; Minimally Invasive Glaucoma Surgery (MIGS); Supraciliary space
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Eye Diseases; Glaucoma; Glaucoma, Open-Angle; Ocular Hypertension; Hypertension
• Other Study ID Numbers: STAR-GLOBAL (ISM09)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No