Open Angle GlaucomaNCT02272569
STARflo European Safety and Efficacy Study
A study testing STARflo Glaucoma Implant in people with Open Angle Glaucoma, run by iSTAR Medical at 8 sites in 5 countries.
Trial summary
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Open Angle Glaucoma
- What is being tested?
- STARflo Glaucoma Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 8 sitesin 5 countries
- Study dates
- Sep 2014to Jul 2019
- 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
Main Inclusion Criteria:
- Diagnosis of refractory open angle glaucoma
- Documented 21 mmHg < IOP ≤ 40 mmHg, under medication
- Patient must provide written informed consent
Main Exclusion Criteria:
- Patients with diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye
- Patients who failed one or more cilio ablative procedure in the study eye if these cilio ablative procedures were performed as a consequence of previous failed filtering surgery
- Clinically significant intra-ocular inflammation or infection, presence of ocular disease such as uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye
Trial locations and contacts
8 sites in 5 countries.
8 sites in 5 countries
France2 sites
Hopital de la Croix-Rousse
Lyon, 69417
CHNO des Quinze Vingts
Paris
Germany2 sites
University Clinic Heidelberg
Heidelberg, 69120
Ludwig-Maximilians-University Munich
Munich, 80336
Switzerland1 site
Universitatsklinik fur Augenheilkunde Inselspital
Bern, 3010
About this study
Official title: A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.
Read the detailed description
This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.
Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.
When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.
Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.
- Conditions
- Open Angle Glaucoma
- Being tested
- STARflo Glaucoma Implant
- Keywords
- glaucoma, glaucoma drainage device, glaucoma shunt
- Medical subject headings
- Glaucoma, Open-Angle, Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
STARflo Glaucoma ImplantDevice
Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.
| Study group | Role | What they receive |
|---|---|---|
| STARflo Glaucoma Implant | Experimental | Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space Receives: Device: STARflo Glaucoma Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
IOP of each patients at baseline will be compared to IOP of patient after 12 months
Measured: 12 months
Secondary outcomes (9)
Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP
IOP of each patients at baseline will be compared to IOP of patient after 24 months
Measured: 24 months
Reduction in number of IOP lowering medications at 12 months vs. baseline
compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months
Measured: 12 months
Reduction in number of IOP lowering medications at 24 months vs. baseline
compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months
Measured: 24 months
Rate of adverse events
assessment and counting of adverse events (% by adverse event) including procedure related complications
Measured: 24 months
Visual Acuity
comparison of visual acuity at 12 months vs. baseline
Measured: 12 months
Absolute success rate (%) at 12 months
absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication
Measured: 12 months
Qualified success rate (%) at 12 months
qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication
Measured: 12 months
Qualified success rate (%) at 24 months
qualified success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline with and without the need for concomitant glaucoma medication
Measured: 24 months
Absolute success rate (%) at 24 months
absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication
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 posted23 Oct 2014 (estimated)
- Study startSep 2014
- Primary completionJul 2018
- Study completionJul 2019
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- iSTAR Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zubair Hussain, PhD, Study chair, Sponsor RepresentativeSheng Lim, Dr., Study director, Medical Advisor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02272569
- Sponsor's protocol ID
- ISM01
- Status last verified
- Feb 2021
- First submitted
- 21 Oct 2014
- Last updated
- 15 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-comparative, Multi-center Clinical Trial to Evaluate the Safety and Efficacy of the STARflo Glaucoma Implant in Patients With Open Angle Glaucoma
- ClinicalTrials.gov ID
- NCT02272569
- Acronym / sponsor ID
- ISM01
- Conditions
- Open Angle Glaucoma
- Keywords
- glaucoma, glaucoma drainage device, glaucoma shunt
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- iSTAR MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2014 (actual)
- Primary completion
- Jul 2018 (actual)
- Study completion
- Jul 2019 (actual)
- First posted
- 23 Oct 2014 (estimated)
- 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.
Prospective, Non-comparative, Multi-center clinical trial to evaluate the safety and efficacy of the STARflo Glaucoma Implant in patients with refractory open angle glaucoma.
Detailed description
This is a prospective, multicenter clinical trial to assess the efficacy and the safety of the STARflo™ Glaucoma Implant.
Patients will enter the study after providing written informed consent. Patients will be screened to confirm that they are eligible for study participation.
When eligibility has been established using the in/exclusion criteria, surgery will be scheduled.
Pre and post-surgery, patients will be evaluated at scheduled intervals (1 day, 1 week, 1 month, 3 months, 6 months, 12 months, 24 months) for a total duration of 24 months following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| STARflo Glaucoma Implant | Experimental | Device: STARflo Glaucoma ImplantImplantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| STARflo Glaucoma ImplantImplantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications. | Device | STARflo Glaucoma Implant |
Primary outcome
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
Time frame: 12 months
IOP of each patients at baseline will be compared to IOP of patient after 12 months
9 secondary outcomes
Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP
Time frame: 24 months
Reduction in number of IOP lowering medications at 12 months vs. baseline
Time frame: 12 months
Reduction in number of IOP lowering medications at 24 months vs. baseline
Time frame: 24 months
Rate of adverse events
Time frame: 24 months
Visual Acuity
Time frame: 12 months
Absolute success rate (%) at 12 months
Time frame: 12 months
Qualified success rate (%) at 12 months
Time frame: 12 months
Qualified success rate (%) at 24 months
Time frame: 24 months
Absolute success rate (%) at 24 months
Time frame: 24 months
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 15 Feb 2021.
Related trials for Open Angle Glaucoma
Recruiting
The Acute Effect of Exercise Type And Timing on Ambulatory Blood Pressure and Intra-Ocular Pressure in Individuals With Glaucoma (The ACHIEVE-project).
Glaucoma Open-Angle Primary, Hypertension
RecruitingObservational study
PRESERFLO™ MicroShunt XI Observational PMCF Study With no Control Group
Primary Open Angle Glaucoma
RecruitingPhase 4
Adaptive Optics OCT Evaluation of Rhopressa's Effects on the Retinal Ganglion Cells in Glaucoma Patients
Open Angle Glaucoma (OAG), Glaucoma
Active, not recruitingObservational study
Impact of Glaucoma and Visual Field Loss on Life Space
Primary Open-angle Glaucoma
Active, not recruitingObservational study
Glaucoma, Visual Field Loss, and Their Association With Life Space in Older Adults
Primary Open Angle Glaucoma
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 chair
Sponsor Representative
Sheng Lim, Dr. study director
Medical Advisor
8 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing STARflo Glaucoma Implant in people with Open Angle Glaucoma, run by iSTAR Medical at 8 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 15 Feb 2021. 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 Belgium, France, Germany, Bulgaria, 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?
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?
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP (time frame: 12 months). 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 15 Feb 2021; AzTrials last refreshed its copy on 2 Nov 2026.