GlaucomaSTAR VIINCT07009236
A Study Evaluating the Safety and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma
A study testing MIGS in people with Glaucoma, run by iSTAR Medical at 5 sites in 2 countries.
Trial summary
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- MIGS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 29 Sep 2025to Dec 2028
- Phase
- Interventional
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females, 20 years of age or older
- Diagnosis of open angle glaucoma (OAG) in the study eye
- Iridocorneal angle grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System in all quadrants of the study eye. (For subject's undergoing combined cataract extraction (with IOL implantation) with MINIject implantation, a grade 2 angle is acceptable prior to cataract surgery so long is the angle becomes grade 3 or greater prior to MINIject implantation).
- Glaucoma not adequately controlled with at least one topical hypotensive medication(s), unless the subject has an allergy / intolerance to a medication or inability to consistently access medication. Examples include but are not limited to prostaglandins, beta blockers, carbonic anhydrase inhibitors or alpha-2-agonists
- Minimal visual acuity in the study eye must be 35 letters EDTRS (20/200) or better and 50 letters ETDRS (20/100) or better in the fellow eye
- Maximal C/D ratio must be 0.9 in the study eye
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- Subjects must be willing and able to follow study instructions and to return for scheduled study-related examinations
- Subjects must provide written informed consent prior to any study procedures
- Part 2 Only: Operable age-related cataract eligible for phacoemulsification surgery with Intraocular Lens (IOL) implantation
- Part 2 Only: The following intraoperative criteria following the IOL implantation need to be met in order for investigator to proceed with the investigational device placement:
- Capsulorhexis is intact and centered
- Posterior capsular bag is intact
- The IOL is well-centered in the capsular bag
- There is no evidence of zonular dehiscence/rupture
- The Anterior Chamber (AC) angle was able to be clearly visualized using direct gonioscopy.
Who cannot join
- Subjects are not eligible for inclusion in this clinical investigation if one or more of the following criteria are met:
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) iridocorneal angle according to Shaffer Angle Grading System in the study eye except for the situation described in inclusion criterion #3.
- Any eye surgery that was performed < 90 days before Screening/Baseline visit in the study eye
- Diagnosis of diabetes mellitus with HbA1C >7%
- Known or suspected allergy or hypersensitivity to medical silicone
- Allergy to fluorescein
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- Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant
- Central endothelial cell density (ECD) at Screening visit with a mean value <1900 cells/mm2 or coefficient of variation (CV) of endothelium >0.45 A variance of 5% less than this cell count is permitted if in the clinical judgement of the Investigator the potential benefit/risk to subject participation is favorable and the central corneal endothelial morphology is characterized as normal by the usual criteria of hexagonality, polymorphism, and polymegathism
- Anticipated need for ocular surgery or retinal laser procedure in the study eye
- Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye,
- Pre-existing ocular or systemic pathology that, in the opinion of the investigator (reason to be specified on the case report form), is likely to cause post-operative complications following implantation
- Central corneal thickness greater than 600 microns
- Clinically significant degenerative visual disorders that, in the opinion of the investigator, can impact study examinations (e.g. exudative macular degeneration or other retinal disorders)
- Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye
- Evidence of crystalline lens subluxation or luxation in the study eye
- Inability to perform Visual Field (VF) testing in either eye
- Evidence of vitreous loss in the anterior chamber in the study eye
- Clinically significant intra-ocular inflammation or infection
- Presence of silicone oil in the study eye
- Participation in any study involving a drug or device within the past 3 months and planned participation to any other study during the present study. There is no exclusion period after completion of the present trial
- Only for women of childbearing potential: positive pregnancy test at Screening/Baseline visit. Pregnant or lactating women
- Subject is under tutorship or trusteeship
- Subject has a condition such that his / her ability to provide personal informed consent is compromised
- Diagnosis of cataract in the study eye that is not age-related e.g., traumatic, inflammatory or resulting from diabetes in the study eye
- Unable to discontinue anticoagulant/antiplatelet therapy (i.e. acetylsalicylic acid, coumadin, heparin, apixaban, etc.) for the surgical procedure. The amount of washout and when to restart therapy after surgery is at the Principal Investigator's discretion and may be based on literature references (see Annexes) or in consultation with the subject's primary care team.
Trial locations and contacts
5 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
5 sites in 2 countries
United Kingdom4 sites, 4 recruiting
- Recruiting
Colchester General Hospital
Colchester, CO45JL
Chrysostomos Dimitriou, Doctor, 00447775 594534, chrysostomos.dimitriou@esneft.nhs.uk
- Recruiting
Diana, Princess of Wales Hospital
Grimsby, DN33 2
Satish Kotta, Doctor, 00441472874111, satish.kotta@nhs.net
- Recruiting
Royal Liverpool University Hospital
Liverpool, L7 3
Neeru Vallabh, Doctor, 00441517062000, Neeru.Vallabh@liverpoolft.nhs.uk
- Recruiting
St Thomas' Hospital
London, SE17EH
Sheng Lim, Doctor, 00442071882289, sheng.lim2@nhs.net
Honduras1 site, 1 recruiting
- Recruiting
Los Robles Vision d/b/a Centro Oftalmológico Robles
Santa Rosa de Copán, 41101
Marco Robles, Doctor, 0050426622028, marock28@gmail.com
About this study
Official title: A Multi-center, Prospective, Cohort Expansion Clinical Study Evaluating the Safety, Usability, Implantation Accuracy and Efficacy of MINIject S+ in Subjects With Open Angle Glaucoma (STAR VII Study)
This is a prospective, multi-center, international, cohort expansion study. Part 1 will be conducted in subjects with open angle glaucoma to identify the best insertion tool for MINIject S+. In Part 1, three different investigational insertion tools will be used to place MINIject implants in this first-in man study. Each arm represents a different version of the insertion tool. Subject and independent central reader will be blinded to the insertion tool used to implant MINIject S+. Part 2 will be an expansion phase where the selected insertion tool will be assessed in a larger population of subjects with open angle glaucoma and operable cataracts undergoing combined glaucoma and cataract surgery (with IOL implantation).
- Conditions
- Glaucoma
- Being tested
- MIGS
- Keywords
- MINIject
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIGSDevice
Implant MINIject S+ in supraciliary space
| Study group | Role | What they receive |
|---|---|---|
| Investigational device FG300X | Active comparator | One version of delivery tool Receives: Device: MIGS |
| Investigational device FG300Y | Active comparator | One version of delivery tool Receives: Device: MIGS |
| Investigational device FG300Z | Active comparator | One version of delivery tool Receives: Device: MIGS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with correct placement of the device in the supraciliary space, as assessed by the blinded central reader
Correct placement at 1 Week will be assessed by SS-AOCT/UBM images, analyzed by an independent central reader.
Measured: 1 week
Ease of use evaluation
Ease of Use, as measured by sponsor review of the surgical procedure and surgeon feedback.
Measured: during the surgery procedure
Secondary outcomes (9)
Change in Best Corrected Visual Acuity from baseline to 6-, 12- and 24-months follow-up
Best corrected visual acuity measured using the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. Change from baseline to 6-, 12- and 24-months follow-up will be evaluated.
Measured: Baseline, 6, 12, and 24 months
Rate of secondary surgical interventions at Month 6, Month 12 and Month 24
Cumulative rate of secondary surgical interventions due to the glaucoma device or related to glaucoma surgical procedure at Month 6, Month 12 and Month 24.
Measured: 6, 12, and 24 months
Change in Endothelial Cell Density from baseline to 6-, 12- and 24-months follow-up
Change from baseline in endothelial cell density (ECD), measured at Month 6, Month 12, and Month 24.
Measured: Baseline, 6, 12 and 24 months
Cumulative Rate of Adverse Events at 6, 12 and 24 months.
Cumulative rate of adverse events (AEs), adverse device effects (ADEs), and adverse events of special interest (AESIs) at 6-, 12- and 24-months follow-up.
Measured: 6, 12 and 24 months
Proportion of eyes achieving ≥20% reduction in diurnal IOP from baseline to 6-, 12- and 24-months follow-up
Proportion of study eyes achieving ≥ 20% reduction in diurnal IOP from baseline to 6 months follow-up, and from baseline to 12- and 24-months follow-up, with or without IOP lowering medications.
Measured: Baseline, 6, 12, 24 months
'Qualified success' rate from baseline to 6-, 12- and 24-months follow-up
'Qualified success' rate at 6-, 12- and 24-month follow-up. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline at a given follow-up visit.
Measured: 6, 12 and 24 months
'Complete success' rate from baseline to 6-, 12- and 24-months follow-up
'Complete success' rate at 6-, 12- and 24-months follow-up. 'Complete success' is defined as diurnal IOP ≤ 21mmHg and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline without the need for any IOP-lowering medication at the given follow-up visit.
Measured: 6, 12 and 24 months
Change in diurnal IOP from baseline to 6-, 12- and 24-months follow-up
Change (absolute and relative) in diurnal IOP from baseline visit to 6-, 12- and 24-months follow-up.
Measured: Baseline, 6, 12 and 24 months
Change in number of IOP-lowering medication from baseline to 6-, 12- and 24-months follow-up.
Change (absolute and relative) in number of IOP-lowering medications from baseline to 6-, 12- and 24-months follow-up.
Measured: Baseline, 6, 12 and 24-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start29 Sep 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2028 (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
- Randomised
- Intervention model
- Parallel groups
- Model description
- FG300X The distal extremity features a closed, blunt tip that opens via a hinge positioned on the upper side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Y The distal extremity features a closed, blunt tip that opens via a hinge positioned on the bottom side. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.25 N +/- 0.06 N. The curvature slope is defined as 1-20%. FG300Z The distal extremity features an open, blunt tip without hinge. The flexibility in the plane "a" is measured by the maximum force required to bend the sheath downward = 0.20 N +/- 0.06 N. The curvature slope is defined as 1-20%.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07009236
- Sponsor's protocol ID
- STAR VII (ISM12)
- Acronym
- STAR VII
- Status last verified
- Oct 2026
- First submitted
- 21 May 2025
- Last updated
- 22 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No