MINIject Glaucoma Implant in European Patients

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03624361

Acronym

STAR-II

Enrollment

Registered

2018-08-10

Start date

2018-05-23

Completion date

2021-09-23

Last updated

2022-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Glaucoma Eye, Glaucoma, Open-Angle, Intraocular Pressure

Keywords

Minimally Invasive Glaucoma Surgery, Glaucoma Implant, Lower IOP, IOP, Intraocular Pressure

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

Interventions

DEVICEGlaucoma 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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Intervention model description

MINIject glaucoma implant CS600 with Dual Operator Delivery Tool

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

France, Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026