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

Glaucoma, Open-Angle Glaucoma Eye Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04517786
• Other study ID #: ISM10
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 15, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: iSTAR Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 21
• Est. completion date: December 31, 2023
• Est. primary completion date: May 16, 2022
• 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 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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
India	Maxivision Super Speciality Eye Hospital	Hyderabad
Panama	Panama Eye Center	Panamá

Sponsors (2)

Lead Sponsor	Collaborator
iSTAR Medical	International Drug Development Institute

Countries where clinical trial is conducted

India,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up	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.	6 month post surgey