STARflo European Safety and Efficacy Study

Not Applicable

Completed

• Conditions: Open Angle Glaucoma
• Interventions: Device: STARflo Glaucoma Implant

• Registration Number: NCT02272569
• Lead Sponsor: iSTAR Medical

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.

Study Timeline

• Study Start: 2014-09
• Study First Submitted: 2014-10-21
• Study First Submitted QC: 2014-10-22
• Study First Posted: 2014-10-23
• Primary Completion: 2018-07
• Study Completion: 2019-07
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-11
• Last Update Posted: 2021-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 42

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
STARflo Glaucoma Implant	STARflo Glaucoma Implant	Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space

Primary Outcome Measures

Name	Time	Method
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP	12 months	IOP of each patients at baseline will be compared to IOP of patient after 12 months

Secondary Outcome Measures

Name	Time	Method
Visual Acuity	12 months	comparison of visual acuity at 12 months vs. baseline
Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP	24 months	IOP of each patients at baseline will be compared to IOP of patient after 24 months
Reduction in number of IOP lowering medications at 12 months vs. baseline	12 months	compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months
Reduction in number of IOP lowering medications at 24 months vs. baseline	24 months	compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months
Rate of adverse events	24 months	assessment and counting of adverse events (% by adverse event) including procedure related complications
Absolute success rate (%) at 12 months	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
Qualified success rate (%) at 12 months	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
Qualified success rate (%) at 24 months	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
Absolute success rate (%) at 24 months	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

Trial Locations

Locations (8)

CHNO des Quinze Vingts; 🇫🇷 Paris, France

MHAT Central Onco Hospital; 🇧🇬 Plovdiv, Bulgaria

UZA; 🇧🇪 Edegem, Belgium

CHU Sart Tilman; 🇧🇪 Liège, Belgium

Hopital de la Croix-Rousse; 🇫🇷 Lyon, France

University Clinic Heidelberg; 🇩🇪 Heidelberg, Germany

Ludwig-Maximilians-University Munich; 🇩🇪 Munich, Germany

Universitatsklinik fur Augenheilkunde Inselspital; 🇨🇭 Bern, Switzerland