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

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

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 Overview

• Status: Completed
• Conditions: Open Angle Glaucoma
• Intervention / Treatment: Device: MINI DO636; Device: MINI SO636

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Colombia
  • Barranquilla, Colombia
    • Clínica Oftalmológica del Caribe
• India
  • Telangana
    • Hyderabad, Telangana, India, 500034
      • Maxivision Eye Hospital
• Panama
  • Panama city, Panama
    • Panama Eye Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MINIject DO Integrated System CS636 (MINI DO636); MINIject 636 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. In this arm the implant is placed using Dual Operator Delivery Tool (DODT).	Device: MINI DO636; 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).
Experimental: MINIject SO Integrated System CS636 (MINI SO636); MINIject 636 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. In this arm the implant is placed using Single Operator Delivery Tool (SODT).	Device: MINI SO636; 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction in medicated diurnal IOP	DODT/SODT arm will be evaluated separately	6 months after surgery

Collaborators and Investigators

• Sponsor: iSTAR Medical

Study record dates

Study Major Dates

• Study Start (Actual): November 25, 2017
• Primary Completion (Actual): January 17, 2019
• Study Completion (Actual): February 8, 2021

Study Registration Dates

• First Submitted: December 12, 2017
• First Submitted That Met QC Criteria: December 14, 2017
• First Posted (Actual): December 15, 2017

Study Record Updates

• Last Update Posted (Actual): April 22, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma; Glaucoma, Open-Angle
• Other Study ID Numbers: ISM05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No