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
1 other identifier
observational
300
6 countries
9
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2020
Longer than P75 for all trials
9 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 5, 2020
CompletedFirst Submitted
Initial submission to the registry
August 20, 2020
CompletedFirst Posted
Study publicly available on registry
August 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedFebruary 28, 2025
February 1, 2025
5.3 years
August 20, 2020
February 26, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Interventions
MINIject implant placed into supraciliary space. The implantation was done in a previous study in which patient participated and is not part of this study.
Eligibility Criteria
patients with open-angle glaucoma not-controlled with hypotensive medications and who, to treat this condition, already received MINIject in a previous study
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iSTAR Medicallead
Study Sites (9)
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
Center Hospotalier Universitaire Genoble Alpes
Grenoble, 38043, France
Hopital de la Croix-Rousse
Lyon, 69417, France
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937, Germany
Universitätsklinikum Mainz
Mainz, Rhineland-Palatinate, 55131, Germany
Klinikum der Universität München
München, 81377, Germany
Maxivision Eye Hospital
Hyderabad, Telangana, 500034, India
Panama Eye Center
Panama City, Panama
Hospital Clínico San Carlos
Madrid, Spain
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zubair Hussain, PhD
iSTAR Medical
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2020
First Posted
August 24, 2020
Study Start
August 5, 2020
Primary Completion
December 1, 2025
Study Completion
December 1, 2025
Last Updated
February 28, 2025
Record last verified: 2025-02
Data Sharing
- IPD Sharing
- Will not share