MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

The study will evaluate the efficacy and safety of MINIject 636 and 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 efficacy objective of the present study is to show the IOP reduction under medication 6 months after surgery compared to medicated diurnal IOP at screening.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Open Angle Glaucoma Eye Diseases Glaucoma Glaucoma, Open-Angle Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Clínica Oftalmológica del Caribe, Barranquilla, Colombia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
Grade 3 (open, 20-35 degrees) or grade 4 (wide open, 35-45 degrees) according to Shaffer Angle Grading System.
Glaucoma not adequately controlled

Exclusion criteria

Diagnosis of glaucoma other than open angle glaucoma
Grade 2, grade 1 and grade 0 according to Shaffer Angle Grading System.
Neovascular glaucoma in the study eye
Prior glaucoma surgery in the study eye
Clinically significant corneal disease
Patients with poor vision

Treatment and study plan

MINI DO636

Device

MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.

The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.

For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.

Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).

DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).

MINI SO636

Device

MINIject 636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant CS636 and a Delivery Tool.

The Delivery Tool is a single-use tool, designed for inserting the CS636 implant into the sub-scleral location through an ab-interno minimally-invasive approach.

For MINIject 636, there are 2 types of Delivery Tools available to implant and position the CS636 implant.

Both types of Delivery Tools are being studied in this amended study: Dual Operator Delivery Tool (DODT) and Single Operator Delivery Tool (SODT).

DODT is used in the first arm (cohort 1 - MINI DO636), SODT is used in the second arm (cohort 2 - MINI SO636).

Primary outcomes

Reduction in medicated diurnal IOP

Time frame: 6 months after surgery

DODT/SODT arm will be evaluated separately

Sponsors and collaborators

Lead sponsor

iSTAR Medical

Industry

Registry information

Official study title

A Prospective, Open, Multicentre Clinical Trial Analysing the Effectiveness and Safety of MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2021
First posted: Dec 15, 2017
Registry last updated: Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed