Clinical trial NCT02272569: STARflo European Safety and Efficacy 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Open Angle Glaucoma
Keywords: glaucoma
glaucoma drainage device
glaucoma shunt
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2014-10-23
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility 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

Primary outcomes:
measure: Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
timeFrame: 12 months
Secondary outcomes:
measure: Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP
timeFrame: 24 months
measure: Reduction in number of IOP lowering medications at 12 months vs. baseline
timeFrame: 12 months
measure: Reduction in number of IOP lowering medications at 24 months vs. baseline
timeFrame: 24 months
measure: Rate of adverse events
timeFrame: 24 months
measure: Visual Acuity
timeFrame: 12 months
measure: Absolute success rate (%) at 12 months
timeFrame: 12 months
measure: Qualified success rate (%) at 12 months
timeFrame: 12 months
measure: Qualified success rate (%) at 24 months
timeFrame: 24 months
measure: Absolute success rate (%) at 24 months
timeFrame: 24 months
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: UZA
city: Liège
country: Belgium
facility: CHU Sart Tilman
city: Plovdiv
country: Bulgaria
facility: MHAT Central Onco Hospital
city: Lyon
country: France
facility: Hopital de la Croix-Rousse
city: Paris
country: France
facility: CHNO des Quinze Vingts
city: Heidelberg
country: Germany
facility: University Clinic Heidelberg
city: Munich
country: Germany
facility: Ludwig-Maximilians-University Munich
city: Bern
country: Switzerland
facility: Universitatsklinik fur Augenheilkunde Inselspital
Study officials:
affiliation: Sponsor Representative
name: Zubair Hussain, PhD
role: STUDY_CHAIR
affiliation: Medical Advisor
name: Sheng Lim, Dr.
role: STUDY_DIRECTOR
References: