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

NCT04517786 | Unknown

• 1 other identifier: ISM10
• Study Type: interventional
• Target: 21
• Locations: 2 countries
• Sites: 2

Brief 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.

Conditions

Glaucoma, Open-Angle Glaucoma Eye

Keywords

Glaucoma; Medical device; MIGS drainage device; eye reduction IOP

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

MINIject CS627 implant

EXPERIMENTAL

MINIject 627 implant is used to reduce intra-ocular pressure in the eye. It is implanted through a minimally-invasive glaucoma surgical intervention in a stand alone procedure.

Device: MINIject CS627 implant

Interventions

MINIject CS627 implant DEVICE

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.

MINIject CS627 implant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• iSTAR Medical: lead
• International Drug Development Institute: collaborator

Study Sites (2)

Maxivision Super Speciality Eye Hospital

Hyderabad, India

Location

Panama Eye Center

Panama City, Panama

Location

MeSH Terms

Conditions

Glaucoma

Condition Hierarchy (Ancestors)

Ocular Hypertension; Eye Diseases

Study Officials

• Zubair Hussain, PhD

  iSTAR

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: MINIject SO627

Study Record Dates

• First Submitted: August 14, 2020
• First Posted: August 18, 2020
• Study Start: January 15, 2021
• Primary Completion: May 16, 2022
• Study Completion: December 31, 2023
• Last Updated: May 3, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1); PA (1)