GlaucomaSTAR-VNCT05024695
Evaluate the Safety and Effectiveness of iSTAR Medical's MINIject™ Implant for Lowering Intraocular Pressure (IOP) in Subjects With Primary Open-angle Glaucoma.
A study testing MINIject™ Implant in people with Glaucoma, run by iSTAR Medical at 37 sites in 4 countries.
Trial summary
Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma. Read more about this study
- Who is it for?
- Ages 46 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- MINIject™ Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 975 participants
- Where
- 37 sitesin 4 countries
- Study dates
- 19 Aug 2021to Jul 2029
- Phase
- Interventional
- 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 46 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females, 46 years of age or older
- A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
- Pseudophakic with prior uncomplicated cataract surgery
Who cannot join
- Angle closure, congenital, or secondary glaucoma
- Diagnosed degenerative visual disorders
- Clinically significant intraocular inflammation or infection
Trial locations and contacts
37 sites in 4 countries.
37 sites in 4 countries
United States28 sites
LA Eye and Laser
Alexandria, Louisiana, 71303
Beverly Hills Institute of Ophthalmology
Beverly Hills, California, 90210
Minnesota Eye Consultants
Bloomington, Minnesota, 55431
Reeve Woods Eye Center
Chico, California, 95926
Glaucoma Associates of Texas
Dallas, Texas, 75231
Intermountain Eye Center
Eagle, Idaho, 83616
El Paso Eye Surgeons
El Paso, Texas, 79922
Vold Vision
Fayetteville, Arkansas, 72704
Eye Associates of Fort Myers
Fort Myers, Florida, 33901
Ophthalmology Associates
Fort Worth, Texas, 76102
Arizona Advanced Eye Research Institute
Glendale, Arizona, 85306
Grand Junction Eye Care
Grand Junction, Colorado, 81501
Houston Eye Associates
Houston, Texas, 77025
Berkeley Eye Center
Houston, Texas, 77027
Eye Centers of Racine and Kenosha
Kenosha, Wisconsin, 53142
Center for Sight Las Vegas
Las Vegas, Nevada, 89145
Apex Eye Clinical Research, LLC
Mason, Ohio, 45040
Vanderbilt Eye Institute
Nashville, Tennessee, 37232
NYU Langone Ophthalmology
New York, New York, 10017
Oklahoma Eye Surgeons
Oklahoma City, Oklahoma, 73112
Eye Consultants PC
Omaha, Nebraska, 68124
Stiles Eyecare Excellene and Glaucoma Institute
Overland Park, Kansas, 66213
Illinois Eye Center
Peoria, Illinois, 61615
Virdi Eye Clinic
Rock Island, Illinois, 61201
Sacramento Eye Consultants, A Medical Corporation
Sacramento, California, 95815
The Eye Institute of Utah
Salt Lake City, Utah, 84107
R and R Eye Research
San Antonio, Texas, 78229
Spokane Eye Clinical Research
Spokane, Washington, 99204
United Kingdom5 sites
Queen Victoria Hospital NHS Foundation Trust
East Grinstead
Glaucoma Service Moorfields Eye Hospital
London
Imperial College Healthcare NHS Trust Western Eye Hospital
London
KCL Frost Eye Research Department St Thomas' Hospital
London
Research & Development Unit, Learning and Research Centre (LaRC), York Hospital
York
Canada3 sites
The Institute de l'Oeil des Laurentides
Boisbriand, Quebec, J7N0C2
Clinique Opthalmologies Bellevue
Montreal
Prism Eye Institute
Oakville, Ontario, L6H 0J8
Switzerland1 site
Swiss Glaucoma Research Foundation Swiss Visio Montchoisi
Lausanne
About this study
Official title: A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
Read the detailed description
This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
- Conditions
- Glaucoma
- Being tested
- MINIject™ Implant
- Keywords
- glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space
- Medical subject headings
- Glaucoma, Glaucoma, Open-Angle, Choroidal Effusions
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIject™ ImplantDevice
The MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space.
| Study group | Role | What they receive |
|---|---|---|
| Implant Group | Experimental | Not described Receives: Device: MINIject™ Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraocular pressure decrease
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
Measured: 24 months
Intraocular pressure decrease (outcome 2)
Change from baseline in mean unmedicated diurnal IOP at Month 24.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Aug 2021
- Study start19 Aug 2021
- Primary completionJul 2027 (estimated)
- Study completionJul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 975 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sabine Glibert, Study director, iSTAR Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05024695
- Sponsor's protocol ID
- ISM06 (STAR-V)
- Acronym
- STAR-V
- Status last verified
- Jun 2025
- First submitted
- 23 Aug 2021
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter Masked Clinical Trial to Evaluate the Safety and Effectiveness of the MINIject CS627 Implant in Subjects With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT05024695
- Acronym / sponsor ID
- STAR-V / ISM06 (STAR-V)
- Conditions
- Glaucoma
- Keywords
- glaucoma, MIGS, primary open angle glaucoma, suprachoroidal space, supraciliary space
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 975 participants (estimated)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- 19 Aug 2021 (actual)
- Primary completion
- Jul 2027 (estimated)
- Study completion
- Jul 2029 (estimated)
- First posted
- 27 Aug 2021 (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.
Evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
Detailed description
This is a prospective, multicenter, masked clinical trial to evaluate the safety and effectiveness of iSTAR Medical's MINIject™ implant for lowering intraocular pressure (IOP) in subjects with primary open-angle glaucoma.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Implant Group | Experimental | Device: MINIject™ Implant |
Who may qualify
- Ages
- 46 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males and females, 46 years of age or older
- A diagnosis of primary open-angle glaucoma, who are candidates for medical therapy, laser treatment, or glaucoma-filtering surgery
- Pseudophakic with prior uncomplicated cataract surgery
Key exclusion criteria (3 listed)
- Angle closure, congenital, or secondary glaucoma
- Diagnosed degenerative visual disorders
- Clinically significant intraocular inflammation or infection
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 |
|---|---|---|
| MINIject™ ImplantThe MINIject™ SO627 is an integrated system for Minimally Invasive Glaucoma Surgery (MIGS) comprised of a glaucoma drainage implant, the MINIject™ SO627 and the SO Delivery System, designed to deliver the MINIject™ implant into the supraciliary space. | Device | Implant Group |
Primary outcome
Intraocular pressure decrease
Time frame: 24 months
Proportion of subjects with ≥ 20% decrease (responders) from Baseline in unmedicated Diurnal IOP at Month 24.
Intraocular pressure decrease (outcome 2)
Time frame: 24 months
Change from baseline in mean unmedicated diurnal IOP at Month 24.
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 12 Sep 2025.
- 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.
Sabine Glibert study director
iSTAR Medical
37 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINIject™ Implant in people with Glaucoma, run by iSTAR Medical at 37 sites in 4 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 3 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 12 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 sites in United States, United Kingdom, Canada, Switzerland. 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?
Intraocular pressure decrease (time frame: 24 months). The study lists 2 primary outcomes in all. 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 12 Sep 2025.