Glaucoma, Open-AngleSTAR-IINCT03624361
MINIject Glaucoma Implant in European Patients
A study testing Glaucoma device implantation in a stand-alone procedure in people with Glaucoma, Open-Angle and Glaucoma Eye, run by iSTAR Medical at 8 sites in 3 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Glaucoma, Open-Angle, Glaucoma Eye, Intraocular Pressure
- What is being tested?
- Glaucoma device implantation in a stand-alone procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 23 May 2018to 23 Sep 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries.
8 sites in 3 countries
Germany5 sites
Uni-Augenklinik Bochum
Bochum, North Rhine-Westphalia, 44892
Uniklinik Köln
Cologne, North Rhine-Westphalia, 50937
Universitätsklinikum Hamburg-Eppendorf
Hamburg, 20246
Universitätsklinikum Mainz
Mainz, Rhineland-Palatinate, 55131
Ludwig-Maximilians-University Munich
Munich, Bavaria, 80336
France2 sites
Center Hospotalier Universitaire Genoble Alpes
Grenoble, 38043
Hôpital de la Croix Rousse
Lyon, 69004
About this study
Official title: 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.
Read the 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
- Conditions
- Glaucoma, Open-Angle, Glaucoma Eye, Intraocular Pressure
- Being tested
- Glaucoma device implantation in a stand-alone procedure
- Keywords
- Minimally Invasive Glaucoma Surgery, Glaucoma Implant, Lower IOP, IOP, Intraocular Pressure
- Medical subject headings
- Glaucoma, Open-Angle
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glaucoma device implantation in a stand-alone procedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Stand-alone | Experimental | 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. Receives: Device: Glaucoma device implantation in a stand-alone procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualified success for lowering the IOP
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
Measured: at 6 months
Secondary outcomes (1)
Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study
show safety of the MINIject implant and the procedure used to implant the device
Measured: up to 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2018
- Study start23 May 2018
- Primary completion31 Dec 2019
- Study completion23 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Glaucoma, Open-AngleStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Norbert Pfeiffer, Prof., Principal investigator, Universitätsklinikum Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03624361
- Sponsor's protocol ID
- STAR-II (ISM04EU)
- Acronym
- STAR-II
- Status last verified
- Aug 2022
- First submitted
- 28 May 2018
- Last updated
- 9 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.
PubMed 32769736
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03624361
- Acronym / sponsor ID
- STAR-II / STAR-II (ISM04EU)
- Conditions
- Glaucoma, Open-Angle, Glaucoma Eye, Intraocular Pressure
- Keywords
- Minimally Invasive Glaucoma Surgery, Glaucoma Implant, Lower IOP, IOP, Intraocular Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- 23 May 2018 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 23 Sep 2021 (actual)
- First posted
- 10 Aug 2018 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
| Arm | Type | Receives |
|---|---|---|
| Stand-alone | Experimental | Device: Glaucoma device implantation in a stand-alone procedurePatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
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 |
|---|---|---|
| Glaucoma device implantation in a stand-alone procedureMINIject 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. | Device | Stand-alone |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
- Results publication: PubMed 32769736Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.
- Homepage of the company and information about the productLink provided by the sponsor.
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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.
Norbert Pfeiffer, Prof. principal investigator
Universitätsklinikum Mainz
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Glaucoma device implantation in a stand-alone procedure in people with Glaucoma, Open-Angle and Glaucoma Eye, run by iSTAR Medical at 8 sites in 3 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 4 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: finished, as of the sponsor's last update on 9 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Germany, France, Spain. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Qualified success for lowering the IOP (time frame: at 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03624361, which also lists 1 linked publication.
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 9 Aug 2022.