MINIject Glaucoma Implant in European Patients

Glaucoma, Open-Angle Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03624361
• Other study ID #: STAR-II (ISM04EU)
• Status: Completed
• Phase: N/A
• Start date: May 23, 2018
• Est. completion date: September 23, 2021

Study information

• Verified date: August 2022
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: September 23, 2021
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma Eye
• Glaucoma, Open-Angle
• Intraocular Pressure

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.

Locations

Country	Name	City	State
France	Center Hospotalier Universitaire Genoble Alpes	Grenoble
France	Hôpital de la Croix Rousse	Lyon
Germany	Uni-Augenklinik Bochum	Bochum	Nordrhein-Westfalen
Germany	Universitätsklinikum Hamburg-Eppendorf	Hamburg
Germany	Uniklinik Köln	Köln	Nordrhein-Westfalen
Germany	Universitätsklinikum Mainz	Mainz	Rheinland Pfalz
Germany	Ludwig-Maximilians-University Munich	Munich	Bavaria
Spain	Hospital Clínico San Carlos	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

France,  Germany,  Spain, 

References & Publications (1)

García Feijoó J, Denis P, Hirneiß C, Aptel F, Perucho González 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 G — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at 6 months
Secondary	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	up to 24 months after surgery

External Links

•   Homepage of the company and information about the product