STARflo European Safety and Efficacy Study

• Register: ClinicalTrials.gov
• Last refreshed on: 22 February 2021
• Main ID: NCT02272569
• Date of registration: 21/10/2014
• Prospective Registration: No
• Primary sponsor: iSTAR Medical
• Public title: STARflo European Safety and Efficacy Study
• Scientific 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
• Date of first enrolment: September 2014
• Target sample size: 42
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02272569
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: N/A

Countries of recruitment

Belgium, Bulgaria, France, Germany, Switzerland

Contacts

• Name: Zubair Hussain, PhD
• Affiliation: Sponsor Representative

• Name: Sheng Lim, Dr.
• Affiliation: Medical Advisor

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Open Angle Glaucoma

Intervention(s)

Device: STARflo Glaucoma Implant

Primary Outcome(s)

Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP [Time Frame: 12 months]

Secondary Outcome(s)

Absolute success rate (%) at 24 months [Time Frame: 24 months]

Rate of adverse events [Time Frame: 24 months]

Qualified success rate (%) at 24 months [Time Frame: 24 months]

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]

Absolute success rate (%) at 12 months [Time Frame: 12 months]

Qualified success rate (%) at 12 months [Time Frame: 12 months]

Visual Acuity [Time Frame: 12 months]

Reduction in number of IOP lowering medications at 24 months vs. baseline [Time Frame: 24 months]

Secondary ID(s)

ISM01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors