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

Open Angle Glaucoma Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03374553
• Other study ID #: ISM05
• Status: Completed
• Phase: N/A
• Start date: November 25, 2017
• Est. completion date: February 8, 2021

Study information

• Verified date: April 2022
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 52
• Est. completion date: February 8, 2021
• Est. primary completion date: January 17, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glaucoma
• Glaucoma, Open-Angle
• Open Angle Glaucoma

Intervention

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).
• 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).

Locations

Country	Name	City	State
Colombia	Clínica Oftalmológica del Caribe	Barranquilla
India	Maxivision Eye Hospital	Hyderabad	Telangana
Panama	Panama Eye Center	Panama city

Sponsors (1)

Lead Sponsor	Collaborator
iSTAR Medical

Countries where clinical trial is conducted

Colombia,  India,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in medicated diurnal IOP	DODT/SODT arm will be evaluated separately	6 months after surgery