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MINIject Glaucoma Implant in European Patients (STAR-II)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03624361
Recruitment Status : Recruiting
First Posted : August 10, 2018
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
iSTAR Medical

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.

Condition or disease Intervention/treatment Phase
Glaucoma, Open-Angle Glaucoma Eye Intraocular Pressure Device: Glaucoma device implantation in a stand-alone procedure Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Intervention Model Description: MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : May 23, 2018
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Glaucoma

Arm Intervention/treatment
Experimental: Stand-alone

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.

Device: Glaucoma device implantation in a stand-alone procedure

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 Measures :
  1. Qualified success for lowering the IOP [ Time Frame: at 6 months ]
    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 :
  1. Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study [ Time Frame: up to 24 months after surgery ]
    show safety of the MINIject implant and the procedure used to implant the device



Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03624361


Contacts
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Contact: Anne Kroker, PhD +32(0)10771671 annek@istarmed.com
Contact: Zubair Hussain, PhD +32(0)10771658 zubair@istarmed.com

Locations
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France
Center Hospotalier Universitaire Genoble Alpes Recruiting
Grenoble, France, 38043
Contact: Florent Aptel, Prof.         
Hôpital de la Croix Rousse Recruiting
Lyon, France, 69004
Contact: Philippe Denis, Prof.         
Germany
Ludwig-Maximilians-University Munich Recruiting
Munich, Bavaria, Germany, 80336
Contact: Christoph Hirneiss, Dr.         
Uni-Augenklinik Bochum Recruiting
Bochum, Nordrhein-Westfalen, Germany, 44892
Contact: Burkhard Dick, Prof.         
Uniklinik Köln Recruiting
Köln, Nordrhein-Westfalen, Germany, 50937
Contact: Thomas Dietlein, Prof.         
Contact       makuladegeneration@uni-koeln.de   
Universitätsklinikum Mainz Recruiting
Mainz, Rheinland Pfalz, Germany, 55131
Contact: Norbert Pfeiffer, Prof.         
Universitätsklinikum Hamburg-Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Maren Klemm, Prof.         
Augenzentrum Rheine Recruiting
Rheine, Germany, 48429
Contact: Florian Kretz, Dr.         
Spain
Hospital Clínico San Carlos Recruiting
Madrid, Spain
Contact: Julian Garcia-Feijoo, Prof.         
Sponsors and Collaborators
iSTAR Medical
Investigators
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Principal Investigator: Norbert Pfeiffer, Prof. Universitätsklinikum Mainz

Additional Information:
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Responsible Party: iSTAR Medical
ClinicalTrials.gov Identifier: NCT03624361     History of Changes
Other Study ID Numbers: STAR-II (ISM04EU)
First Posted: August 10, 2018    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by iSTAR Medical:
Minimally Invasive Glaucoma Surgery
Glaucoma Implant
Lower IOP
IOP
Intraocular Pressure

Additional relevant MeSH terms:
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Glaucoma
Glaucoma, Open-Angle
Ocular Hypertension
Eye Diseases