MINIject Global Long-Term Follow-up Study

Ocular Hypertension Clinical Trial

— STAR-GLOBAL  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04524416
• Other study ID #: STAR-GLOBAL (ISM09)
• Status: Recruiting
• Start date: August 5, 2020
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: iSTAR Medical
• Contact: Esma Islamaj, PhD
• Phone: +32 10 77 12 52
• Email: esma.islamaj[@]istarmed.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Hypertension
• Ocular Hypertension
• Open Angle Glaucoma

Intervention

Device:
• Minimally invasive glaucoma surgery (MIGS)
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.

Locations

Country	Name	City	State
Colombia	Clinica Oftalmologica del Caribe	Barranquilla
France	Center Hospotalier Universitaire Genoble Alpes	Grenoble
France	Hopital de la Croix-Rousse	Lyon
Germany	Uniklinik Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Mainz	Mainz	Rheinland Pfalz
Germany	Klinikum der Universität München	München
India	Maxivision Eye Hospital	Hyderabad	Telangana
Panama	Panama Eye Center	Panama City
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Colombia,  France,  Germany,  India,  Panama,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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