NCT03374553 - MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications | Crick

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

52

Conditions

Open Angle Glaucoma

Interventions

MINI DO636DEVICE

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 SO636DEVICE

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).

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Clínica Oftalmológica del Caribe

Barranquilla, Colombia

Maxivision Eye Hospital

Hyderabad, Telangana, India

Panama Eye Center

Panama City, Panama

Outcomes

Primary Outcomes

Reduction in medicated diurnal IOP

DODT/SODT arm will be evaluated separately

Time frame: 6 months after surgery