MINIject Glaucoma Implant in European Patients

Not Applicable

Completed

• Conditions: Glaucoma, Open-Angle; Intraocular Pressure; Glaucoma Eye
• Interventions: Device: Glaucoma device implantation in a stand-alone procedure

• Registration Number: NCT03624361
• Lead Sponsor: 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.

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

Study Timeline

• Study Start: 2018-05-23
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-08-08
• Study First Posted: 2018-08-10
• Primary Completion: 2019-12-31
• Study Completion: 2021-09-23
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 29

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stand-alone	Glaucoma device implantation in a stand-alone procedure	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.

Primary Outcome Measures

Name	Time	Method
Qualified success for lowering the IOP	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

Name	Time	Method
Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study	up to 24 months after surgery	show safety of the MINIject implant and the procedure used to implant the device

Trial Locations

Locations (8)

Hospital Clínico San Carlos; 🇪🇸 Madrid, Spain

Center Hospotalier Universitaire Genoble Alpes; 🇫🇷 Grenoble, France

Hôpital de la Croix Rousse; 🇫🇷 Lyon, France

Ludwig-Maximilians-University Munich; 🇩🇪 Munich, Bavaria, Germany

Uni-Augenklinik Bochum; 🇩🇪 Bochum, Nordrhein-Westfalen, Germany

Uniklinik Köln; 🇩🇪 Köln, Nordrhein-Westfalen, Germany

Universitätsklinikum Hamburg-Eppendorf; 🇩🇪 Hamburg, Germany

Universitätsklinikum Mainz; 🇩🇪 Mainz, Rheinland Pfalz, Germany