STARflo European Safety and Efficacy Study

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.

Study Overview

• Status: Completed
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: STARflo Glaucoma Implant

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 Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Edegem, Belgium, 2650
    • UZA
  • Liège, Belgium
    • CHU Sart Tilman
• Bulgaria
  • Plovdiv, Bulgaria
    • MHAT Central Onco Hospital
• France
  • Lyon, France, 69417
    • Hôpital de la Croix-Rousse
  • Paris, France
    • CHNO des Quinze Vingts
• Germany
  • Heidelberg, Germany, 69120
    • University Clinic Heidelberg
  • Munich, Germany, 80336
    • Ludwig-Maximilians-University Munich
• Switzerland
  • Bern, Switzerland, 3010
    • Universitatsklinik fur Augenheilkunde Inselspital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: STARflo Glaucoma Implant; Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space	Device: STARflo Glaucoma Implant; Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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	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	24 months
Rate of adverse events	assessment and counting of adverse events (% by adverse event) including procedure related complications	24 months
Visual Acuity	comparison of visual acuity at 12 months vs. baseline	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	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	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	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	24 months

Collaborators and Investigators

• Sponsor: iSTAR Medical
• Investigators: Study Chair: Zubair Hussain, PhD, Sponsor Representative; Study Director: Sheng Lim, Dr., Medical Advisor

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2014
• Primary Completion (ACTUAL): July 1, 2018
• Study Completion (ACTUAL): July 1, 2019

Study Registration Dates

• First Submitted: October 21, 2014
• First Submitted That Met QC Criteria: October 22, 2014
• First Posted (ESTIMATE): October 23, 2014

Study Record Updates

• Last Update Posted (ACTUAL): February 15, 2021
• Last Update Submitted That Met QC Criteria: February 11, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: glaucoma; glaucoma shunt; glaucoma drainage device
• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ISM01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No