MINIject Glaucoma Implant in European Patients (STAR-II)
August 8, 2022 updated by: iSTAR Medical
A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications.
The procedure will be a stand-alone surgery.
Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%.
'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
Study Type
Interventional
Enrollment (Actual)
29
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Grenoble, France, 38043
- Center Hospotalier Universitaire Genoble Alpes
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Lyon, France, 69004
- Hopital de la croix rousse
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Hamburg, Germany, 20246
- Universitätsklinikum Hamburg-Eppendorf
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Bavaria
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Munich, Bavaria, Germany, 80336
- Ludwig-Maximilians-University Munich
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Nordrhein-Westfalen
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Bochum, Nordrhein-Westfalen, Germany, 44892
- Uni-Augenklinik Bochum
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Köln, Nordrhein-Westfalen, Germany, 50937
- Uniklinik Köln
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Rheinland Pfalz
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Mainz, Rheinland Pfalz, Germany, 55131
- Universitätsklinikum Mainz
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Madrid, Spain
- Hospital Clinico San Carlos
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
46 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males or females, 50 years of age or older.
- Diagnosis of primary open angle glaucoma during screening visit or earlier.
- Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.
Exclusion Criteria:
- Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
- Neovascular glaucoma in the study eye.
- Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Stand-alone
Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. |
MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Qualified success for lowering the IOP
Time Frame: at 6 months
|
The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%.
'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and > 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
|
at 6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study
Time Frame: up to 24 months after surgery
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show safety of the MINIject implant and the procedure used to implant the device
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up to 24 months after surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Norbert Pfeiffer, Prof., Universitätsklinikum Mainz
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 23, 2018
Primary Completion (Actual)
December 31, 2019
Study Completion (Actual)
September 23, 2021
Study Registration Dates
First Submitted
May 28, 2018
First Submitted That Met QC Criteria
August 8, 2018
First Posted (Actual)
August 10, 2018
Study Record Updates
Last Update Posted (Actual)
August 9, 2022
Last Update Submitted That Met QC Criteria
August 8, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STAR-II (ISM04EU)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.