MINIject Global Long-Term Follow-up Study

NCT04524416 | Active Not Recruiting

• 1 other identifier: STAR-GLOBAL (ISM09)
• Study Type: observational
• Target: 116
• Locations: 6 countries
• Sites: 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.

Conditions

Open Angle Glaucoma; Ocular Hypertension

Keywords

Open Angle Glaucoma; Intra Ocular Pressure (IOP) reduction; Glaucoma Drainage Device; Minimally Invasive Glaucoma Surgery (MIGS); Supraciliary space; Ocular hypertension

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

Minimally invasive glaucoma surgery (MIGS) DEVICE

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

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

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

Sponsors & Collaborators

• iSTAR Medical: lead

Study Sites (9)

Clinica Oftalmologica del Caribe

Barranquilla, Colombia

Location

Center Hospotalier Universitaire Genoble Alpes

Grenoble, 38043, France

Location

Hopital de la Croix-Rousse

Lyon, 69417, France

Location

Uniklinik Köln

Cologne, North Rhine-Westphalia, 50937, Germany

Location

Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, 55131, Germany

Location

Klinikum der Universität München

München, 81377, Germany

Location

Maxivision Eye Hospital

Hyderabad, Telangana, 500034, India

Location

Panama Eye Center

Panama City, Panama

Location

Hospital Clínico San Carlos

Madrid, Spain

Location

MeSH Terms

Conditions

Glaucoma, Open-Angle; Ocular Hypertension

Condition Hierarchy (Ancestors)

Glaucoma; Eye Diseases

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 (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 11, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2); CO (1); IN (1); ES (1); DE (3); PA (1)