Glaucoma, Open-Angle Glaucoma EyeNCT04517786
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
A study testing MINIject CS627 implant in people with Glaucoma, Open-Angle Glaucoma Eye, run by iSTAR Medical at 2 sites in 2 countries.
Trial summary
The study will assess 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 years and older
- Conditions the study is for
- Glaucoma, Open-Angle Glaucoma Eye
- What is being tested?
- MINIject CS627 implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 15 Jan 2021to 31 Dec 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- Grade 3 or grade 4 according to Shaffer Angle Grading System.
- Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
Who cannot join
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
- Neovascular glaucoma in the study eye.
- Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
- Prior glaucoma surgery in the study eye.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool
The study will assess 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 will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.
The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
- Conditions
- Glaucoma, Open-Angle Glaucoma Eye
- Being tested
- MINIject CS627 implant
- Keywords
- Glaucoma, Medical device, MIGS drainage device, eye reduction IOP
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MINIject CS627 implantDevice
MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool.
The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.
| Study group | Role | What they receive |
|---|---|---|
| MINIject CS627 implant | Experimental | MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure. Receives: Device: MINIject CS627 implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.
Measured: 6 month post surgey
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2020
- Study start15 Jan 2021
- Primary completion16 May 2022
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glaucoma, Open-Angle Glaucoma EyeStudies 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 SO627
- Masking
- None (open label)
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International Drug Development Institute
- Responsible party
- Sponsor
- Investigators
- Zubair Hussain, PhD, Study director, iSTAR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04517786
- Sponsor's protocol ID
- ISM10
- Status last verified
- May 2023
- First submitted
- 14 Aug 2020
- Last updated
- 3 May 2023
- Results posted
- No
- Data monitoring committee
- 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool
- ClinicalTrials.gov ID
- NCT04517786
- Acronym / sponsor ID
- ISM10
- Conditions
- Glaucoma, Open-Angle Glaucoma Eye
- Keywords
- Glaucoma, Medical device, MIGS drainage device, eye reduction IOP
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 21 participants (actual)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Collaborators
- International Drug Development Institute
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 16 May 2022 (actual)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 18 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 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 will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.
The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- MINIject SO627
| Arm | Type | Receives |
|---|---|---|
| MINIject CS627 implant | Experimental | Device: MINIject CS627 implantMINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
- Grade 3 or grade 4 according to Shaffer Angle Grading System.
- Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.
Key exclusion criteria (4 listed)
- Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
- Neovascular glaucoma in the study eye.
- Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
- Prior glaucoma surgery in the study eye.
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 CS627 implantMINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye. | Device | MINIject CS627 implant |
Primary outcome
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
Time frame: 6 month post surgey
The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- 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.
Zubair Hussain, PhD study director
iSTAR
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MINIject CS627 implant in people with Glaucoma, Open-Angle Glaucoma Eye, run by iSTAR Medical at 2 sites in 2 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: status not confirmed, as of the sponsor's last update on 3 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in India, Panama. 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?
Results are not available in the source record.
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?
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up (time frame: 6 month post surgey). 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 3 May 2023.