Open Angle GlaucomaSTAR-GLOBALNCT04524416
MINIject Global Long-Term Follow-up Study
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by iSTAR Medical at 9 sites in 6 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Open Angle Glaucoma, Ocular Hypertension
- What is being tested?
- Minimally invasive glaucoma surgery (MIGS)
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 9 sitesin 6 countries
- Study dates
- 5 Aug 2020to Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
9 sites in 6 countries.
9 sites in 6 countries
Germany3 sites
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Mainz
Mainz, Rhineland-Palatinate, 55131
Klinikum der Universität München
München, 81377
France2 sites
Center Hospotalier Universitaire Genoble Alpes
Grenoble, 38043
Hopital de la Croix-Rousse
Lyon, 69417
About this study
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
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.
Read the detailed 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.
- Conditions
- Open Angle Glaucoma, Ocular Hypertension
- Being tested
- Minimally invasive glaucoma surgery (MIGS)
- Keywords
- Open Angle Glaucoma, Intra Ocular Pressure (IOP) reduction, Glaucoma Drainage Device, Minimally Invasive Glaucoma Surgery (MIGS), Supraciliary space, Ocular hypertension
- Medical subject headings
- Glaucoma, Open-Angle, Ocular Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 5 years post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start5 Aug 2020
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Open Angle GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524416
- Sponsor's protocol ID
- STAR-GLOBAL (ISM09)
- Acronym
- STAR-GLOBAL
- Status last verified
- Jun 2026
- First submitted
- 20 Aug 2020
- Last updated
- 11 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04524416
- Acronym / sponsor ID
- STAR-GLOBAL / STAR-GLOBAL (ISM09)
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 116 participants (actual)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- 5 Aug 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Proportion of patients with serious device-related adverse event in study eye
Time frame: 5 years post-implantation
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
9 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Open Angle Glaucoma and Ocular Hypertension, run by iSTAR Medical at 9 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 11 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Germany, France, Colombia, India, Panama and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients with serious device-related adverse event in study eye (time frame: 5 years post-implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2026.