Back to resultsMINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
Primary Purpose
Glaucoma, Open-Angle Glaucoma Eye
Status
Active
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MINIject CS627 implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma, Open-Angle Glaucoma Eye focused on measuring Glaucoma, Medical device, MIGS drainage device, eye reduction IOP
Eligibility Criteria
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.
Sites / Locations
- Maxivision Super Speciality Eye Hospital
- Panama Eye Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MINIject CS627 implant
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04517786
First Posted
August 14, 2020
Last Updated
May 2, 2023
Sponsor
iSTAR Medical
Collaborators
International Drug Development Institute
1. Study Identification
Unique Protocol Identification Number
NCT04517786
Brief Title
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
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
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 15, 2021 (Actual)
Primary Completion Date
May 16, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iSTAR Medical
Collaborators
International Drug Development Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma, Open-Angle Glaucoma Eye
Keywords
Glaucoma, Medical device, MIGS drainage device, eye reduction IOP
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
MINIject SO627
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MINIject CS627 implant
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
MINIject CS627 implant
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in medicated or unmedicated (without washout) mean diurnal IOP at 6 months follow-up
Description
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.
Time Frame
6 month post surgey
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair Hussain, PhD
Organizational Affiliation
iSTAR
Official's Role
Study Director
Facility Information:
Facility Name
Maxivision Super Speciality Eye Hospital
City
Hyderabad
Country
India
Facility Name
Panama Eye Center
City
Panamá
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MINIject (MINI SO627) in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
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