MINIject Glaucoma Implant in European Patients

iSTAR Medical29 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Glaucoma, Open-Angle Glaucoma Eye Intraocular Pressure

Interventions

Glaucoma device implantation in a stand-alone procedureDEVICE

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.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

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.

Locations (8)

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, North Rhine-Westphalia, Germany

Outcomes

Primary Outcomes

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

Time frame: at 6 months

Secondary Outcomes

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

Time frame: up to 24 months after surgery

Data from ClinicalTrials.gov

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