Clinical trial NCT03624361: MINIject Glaucoma Implant in European Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Glaucoma, Open-Angle
Glaucoma Eye
Intraocular Pressure
Keywords: Minimally Invasive Glaucoma Surgery
Glaucoma Implant
Lower IOP
IOP
Intraocular Pressure
Lead sponsor: iSTAR Medical
Sponsor class: INDUSTRY
First posted: 2018-08-10
Enrollment: 29
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: MINIject glaucoma implant CS600 with Dual Operator Delivery Tool
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Qualified success for lowering the IOP
timeFrame: at 6 months
Secondary outcomes:
measure: Safety assessment of device in terms of adverse events (AEs) and serious adverse events (SAEs) reported during duration of study
timeFrame: up to 24 months after surgery
Other outcomes:
Locations:
city: Grenoble
country: France
facility: Center Hospotalier Universitaire Genoble Alpes
city: Lyon
country: France
facility: Hôpital de la Croix Rousse
city: Munich
country: Germany
facility: Ludwig-Maximilians-University Munich
state: Bavaria
city: Bochum
country: Germany
facility: Uni-Augenklinik Bochum
state: Nordrhein-Westfalen
city: Köln
country: Germany
facility: Uniklinik Köln
state: Nordrhein-Westfalen
city: Mainz
country: Germany
facility: Universitätsklinikum Mainz
state: Rheinland Pfalz
city: Hamburg
country: Germany
facility: Universitätsklinikum Hamburg-Eppendorf
city: Madrid
country: Spain
facility: Hospital Clínico San Carlos
Study officials:
affiliation: Universitätsklinikum Mainz
name: Norbert Pfeiffer, Prof.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Garcia Feijoo J, Denis P, Hirneiss C, Aptel F, Perucho Gonzalez 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 Glaucoma. 2020 Oct;29(10):864-871. doi: 10.1097/IJG.0000000000001632.