MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool

Sponsor

iSTAR Medical (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04517786

Collaborator

International Drug Development Institute (Other)

Enrollment

Locations

Arm

32.5

Anticipated Duration (Months)

12.5

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The study will assess safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.

Condition or Disease	Intervention/Treatment	Phase
Glaucoma, Open-Angle Glaucoma Eye	Device: MINIject CS627 implant	N/A

Detailed Description

The study will evaluate the efficacy and safety of MINI SO627 and IOP (Intra- ocular pressure) lowering effects with or without the use of glaucoma medications. The procedure will be a stand alone surgery. Patient follow up with several examinations up to 24 months after surgery.

The primary endpoint is the reduction in medicated mean diurnal IOP at 6 months follow up compared to medicated diurnal IOP at baseline visit.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

MINIject SO627MINIject SO627

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

A Prospective, Open, Clinical Trial Analysing The Efficacy and Safety of MINIJECT (MINI SO627) In Patients With Open Angle Glaucoma Uncontrolled By Topical Hypotensive Medications Using A Single Operator Delivery Tool

Actual Study Start Date :

Jan 15, 2021

Anticipated Primary Completion Date :

Nov 30, 2022

Anticipated Study Completion Date :

Sep 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MINIject CS627 implant MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.	Device: MINIject CS627 implant MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.

Arm

Intervention/Treatment

Experimental: MINIject CS627 implant

MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.

Device: MINIject CS627 implant

MINI SO627 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant (CS627) and a single operator delivery tool. The delivery tool is a single-use tool, designed for inserting the CS627 implant into the suprachoroidal space in the eye.

Outcome Measures

Primary Outcome Measures

Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up [6 month post surgey]
The primary endpoint of the study is the reduction in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up compared to medicated or unmedicated (without washout) diurnal IOP at baseline visit.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
Grade 3 or grade 4 according to Shaffer Angle Grading System.
Glaucoma not adequately controlled by one to four different topical hypotensive medication(s), given each for at least one month, as confirmed by 21mmHg < IOP < 35 mmHg in the study eye at baseline visit.

Exclusion Criteria:

Grade 2 (narrow, 20 degrees), grade 1 (extremely narrow, less or equal to 10 degrees) and grade 0 (closed or slit) according to Shaffer Angle Grading System in the study eye.
Neovascular glaucoma in the study eye.
Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
Prior glaucoma surgery in the study eye.