MINIject Global Long-Term Follow-up Study

NCT ID: NCT04524416

Last Updated: 2025-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-08-05

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Open Angle Glaucoma Ocular Hypertension

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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iSTAR Medical

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zubair Hussain, PhD

Role: STUDY_DIRECTOR

iSTAR Medical

Locations

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Clinica Oftalmologica del Caribe

Barranquilla, , Colombia

Site Status RECRUITING

Center Hospotalier Universitaire Genoble Alpes

Grenoble, , France

Site Status ACTIVE_NOT_RECRUITING

Hopital de la Croix-Rousse

Lyon, , France

Site Status ACTIVE_NOT_RECRUITING

Uniklinik Köln

Cologne, North Rhine-Westphalia, Germany

Site Status ACTIVE_NOT_RECRUITING

Universitätsklinikum Mainz

Mainz, Rhineland-Palatinate, Germany

Site Status ACTIVE_NOT_RECRUITING

Klinikum der Universität München

München, , Germany

Site Status RECRUITING

Maxivision Eye Hospital

Hyderabad, Telangana, India

Site Status RECRUITING

Panama Eye Center

Panama City, , Panama

Site Status ACTIVE_NOT_RECRUITING

Hospital Clínico San Carlos

Madrid, , Spain

Site Status ACTIVE_NOT_RECRUITING

Countries

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Colombia France Germany India Panama Spain

Central Contacts

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Esma Islamaj, PhD

Role: CONTACT

+32 10 77 12 52

Pascale Ducloux

Role: CONTACT

Facility Contacts

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Jose Luis Rodriguez, MD

Role: primary

Marc Mackert, MD.

Role: primary

Anitha Kamarthy, MD

Role: primary

Other Identifiers

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STAR-GLOBAL (ISM09)

Identifier Type: -

Identifier Source: org_study_id

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