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STARflo European Safety and Efficacy Study

Primary Purpose

Open Angle Glaucoma

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
STARflo Glaucoma Implant
Sponsored by
iSTAR Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Open Angle Glaucoma focused on measuring glaucoma, glaucoma drainage device, glaucoma shunt

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UZA
  • CHU Sart Tilman
  • MHAT Central Onco Hospital
  • Hopital de la Croix-Rousse
  • CHNO des Quinze Vingts
  • University Clinic Heidelberg
  • Ludwig-Maximilians-University Munich
  • Universitatsklinik fur Augenheilkunde Inselspital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

STARflo Glaucoma Implant

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
October 21, 2014
Last Updated
February 11, 2021
Sponsor
iSTAR Medical
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1. Study Identification

Unique Protocol Identification Number
NCT02272569
Brief Title
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

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2014 (Actual)
Primary Completion Date
July 2018 (Actual)
Study Completion Date
July 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iSTAR Medical

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
Keywords
glaucoma, glaucoma drainage device, glaucoma shunt

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
STARflo Glaucoma Implant
Arm Type
Experimental
Arm Description
Implantation of the STARflo Glaucoma Implant by an ab-externa technique with connection from the anterior chamber to the suprachoroidal space
Intervention Type
Device
Intervention Name(s)
STARflo Glaucoma Implant
Intervention Description
Implantation of the STARflo Glaucoma Implant following surgical technique described in European labelling. Procedure does not require the use of anti-fibrotic medications.
Primary Outcome Measure Information:
Title
Reduction in mean diurnal intraocular pressure (IOP) at 12 months vs. baseline IOP
Description
IOP of each patients at baseline will be compared to IOP of patient after 12 months
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Reduction in mean diurnal intraocular pressure (IOP) at 24 months vs. baseline IOP
Description
IOP of each patients at baseline will be compared to IOP of patient after 24 months
Time Frame
24 months
Title
Reduction in number of IOP lowering medications at 12 months vs. baseline
Description
compare number of active ingredient of each patients at baseline vs number of active ingredient after 12 months
Time Frame
12 months
Title
Reduction in number of IOP lowering medications at 24 months vs. baseline
Description
compare number of active ingredient of each patients at baseline vs number of active ingredient after 24 months
Time Frame
24 months
Title
Rate of adverse events
Description
assessment and counting of adverse events (% by adverse event) including procedure related complications
Time Frame
24 months
Title
Visual Acuity
Description
comparison of visual acuity at 12 months vs. baseline
Time Frame
12 months
Title
Absolute success rate (%) at 12 months
Description
absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication
Time Frame
12 months
Title
Qualified success rate (%) at 12 months
Description
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
Time Frame
12 months
Title
Qualified success rate (%) at 24 months
Description
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
Time Frame
24 months
Title
Absolute success rate (%) at 24 months
Description
absolute success: IOP < 21mmHg and < 5mmHg with a minimum of 30% IOP reduction compared to baseline without the need for concomitant glaucoma medication
Time Frame
24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair Hussain, PhD
Organizational Affiliation
Sponsor Representative
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Sheng Lim, Dr.
Organizational Affiliation
Medical Advisor
Official's Role
Study Director
Facility Information:
Facility Name
UZA
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Sart Tilman
City
Liège
Country
Belgium
Facility Name
MHAT Central Onco Hospital
City
Plovdiv
Country
Bulgaria
Facility Name
Hopital de la Croix-Rousse
City
Lyon
ZIP/Postal Code
69417
Country
France
Facility Name
CHNO des Quinze Vingts
City
Paris
Country
France
Facility Name
University Clinic Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Ludwig-Maximilians-University Munich
City
Munich
ZIP/Postal Code
80336
Country
Germany
Facility Name
Universitatsklinik fur Augenheilkunde Inselspital
City
Bern
ZIP/Postal Code
3010
Country
Switzerland

12. IPD Sharing Statement

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STARflo European Safety and Efficacy Study

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