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MINIject Glaucoma Implant in European Patients (STAR-II)

Primary Purpose

Glaucoma, Open-Angle, Glaucoma Eye, Intraocular Pressure

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Glaucoma device implantation in a stand-alone procedure
Sponsored by
iSTAR Medical
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Glaucoma, Open-Angle focused on measuring Minimally Invasive Glaucoma Surgery, Glaucoma Implant, Lower IOP, IOP, Intraocular Pressure

Eligibility Criteria

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

Inclusion Criteria:

  • Males or females, 50 years of age or older.
  • Diagnosis of primary open angle glaucoma during screening visit or earlier.
  • Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System.

Exclusion Criteria:

  • Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye.
  • Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System.
  • Neovascular glaucoma in the study eye.
  • Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.

Sites / Locations

  • Center Hospotalier Universitaire Genoble Alpes
  • Hôpital de la Croix Rousse
  • Ludwig-Maximilians-University Munich
  • Uni-Augenklinik Bochum
  • Uniklinik Köln
  • Universitätsklinikum Mainz
  • Universitätsklinikum Hamburg-Eppendorf
  • Hospital Clínico San Carlos

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Stand-alone

Arm Description

Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.

Outcomes

Primary Outcome Measures

Qualified success for lowering the IOP
The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and > 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

Secondary Outcome Measures

Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study
show safety of the MINIject implant and the procedure used to implant the device

Full Information

First Posted
May 28, 2018
Last Updated
August 8, 2022
Sponsor
iSTAR Medical
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1. Study Identification

Unique Protocol Identification Number
NCT03624361
Brief Title
MINIject Glaucoma Implant in European Patients
Acronym
STAR-II
Official Title
A Prospective, Open, Multicentre Clinical Trial With One Cohort Analysing the Efficacy and Safety of MINIject in European Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Completed
Study Start Date
May 23, 2018 (Actual)
Primary Completion Date
December 31, 2019 (Actual)
Study Completion Date
September 23, 2021 (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
Yes

5. Study Description

Brief Summary
The study will evaluate the efficacy and safety of the MINIject glaucoma implant and Intraocular Pressure (IOP) lowering effects with or without glaucoma medications. The procedure will be a stand-alone surgery. Overall, the patient will be asked to perform several examinations up to 24 months after surgery.
Detailed Description
The primary endpoint is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21mmHg (millimeter mercury) and > 5mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle, Glaucoma Eye, Intraocular Pressure
Keywords
Minimally Invasive Glaucoma Surgery, Glaucoma Implant, Lower IOP, IOP, Intraocular Pressure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
Masking
None (Open Label)
Allocation
N/A
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stand-alone
Arm Type
Experimental
Arm Description
Patients will receive MINIject Glaucoma implant in a stand-alone procedure. MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention.
Intervention Type
Device
Intervention Name(s)
Glaucoma device implantation in a stand-alone procedure
Intervention Description
MINIject implant is used to reduce intra-ocular pressure in the eye through a minimally-invasive Glaucoma surgical intervention. The intervention is to be performed as stand-alone surgery.
Primary Outcome Measure Information:
Title
Qualified success for lowering the IOP
Description
The primary objective is the 'qualified success' rate at 6 months after surgery greater than 60%. 'Qualified success' is defined as a diurnal IOP ≤ 21 mmHg and > 5 mmHg with a minimum 20% diurnal IOP reduction from baseline with or without the concomitant use of allowed glaucoma hypotensive medication at 6 months after surgery
Time Frame
at 6 months
Secondary Outcome Measure Information:
Title
Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study
Description
show safety of the MINIject implant and the procedure used to implant the device
Time Frame
up to 24 months after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Males or females, 50 years of age or older. Diagnosis of primary open angle glaucoma during screening visit or earlier. Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shafer Angle Grading System. Exclusion Criteria: Diagnosis of glaucoma other than primary open angle glaucoma (e.g. angle closure glaucoma or secondary open angle glaucoma) in the study eye. Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shafer Angle Grading System. Neovascular glaucoma in the study eye. Corneal opacity or iridocorneal angle not visible through gonioscopy prisma in the study eye, preventing correct placement of the implant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Norbert Pfeiffer, Prof.
Organizational Affiliation
Universitätsklinikum Mainz
Official's Role
Principal Investigator
Facility Information:
Facility Name
Center Hospotalier Universitaire Genoble Alpes
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital de la Croix Rousse
City
Lyon
ZIP/Postal Code
69004
Country
France
Facility Name
Ludwig-Maximilians-University Munich
City
Munich
State/Province
Bavaria
ZIP/Postal Code
80336
Country
Germany
Facility Name
Uni-Augenklinik Bochum
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44892
Country
Germany
Facility Name
Uniklinik Köln
City
Köln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50937
Country
Germany
Facility Name
Universitätsklinikum Mainz
City
Mainz
State/Province
Rheinland Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Hospital Clínico San Carlos
City
Madrid
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32769736
Citation
Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez L, Hussain Z, Lorenz K, Pfeiffer N; STAR-II Investigators. A European Study of the Performance and Safety of MINIject in Patients With Medically Uncontrolled Open-angle Glaucoma (STAR-II). J Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.
Results Reference
result
Links:
URL
https://www.istarmed.com/
Description
Homepage of the company and information about the product

Learn more about this trial

MINIject Glaucoma Implant in European Patients

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