STAR-II: MINIject Glaucoma Implant in European Patients

Sponsor

iSTAR Medical (Industry)

Overall Status

Completed

CT.gov ID

NCT03624361

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

3.6

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Glaucoma Eye Intraocular Pressure	Device: Glaucoma device implantation in a stand-alone procedure	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

29 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

MINIject glaucoma implant CS600 with Dual Operator Delivery ToolMINIject glaucoma implant CS600 with Dual Operator Delivery Tool

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

May 23, 2018

Actual Primary Completion Date :

Dec 31, 2019

Actual Study Completion Date :

Sep 23, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Stand-alone 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.	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.

Arm

Intervention/Treatment

Experimental: Stand-alone

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.

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.

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Center Hospotalier Universitaire Genoble Alpes	Grenoble		France	38043
2	Hôpital de la Croix Rousse	Lyon		France	69004
3	Ludwig-Maximilians-University Munich	Munich	Bavaria	Germany	80336
4	Uni-Augenklinik Bochum	Bochum	Nordrhein-Westfalen	Germany	44892
5	Uniklinik Köln	Köln	Nordrhein-Westfalen	Germany	50937
6	Universitätsklinikum Mainz	Mainz	Rheinland Pfalz	Germany	55131
7	Universitätsklinikum Hamburg-Eppendorf	Hamburg		Germany	20246
8	Hospital Clínico San Carlos	Madrid		Spain