Back to resultsMINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
Primary Purpose
Open Angle Glaucoma
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
MINI DO636
MINI SO636
Sponsored by
About this trial
This is an interventional treatment trial for Open Angle Glaucoma
Eligibility Criteria
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
Sites / Locations
- Clínica Oftalmológica del Caribe
- Maxivision Eye Hospital
- Panama Eye Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
MINIject DO Integrated System CS636 (MINI DO636)
MINIject SO Integrated System CS636 (MINI SO636)
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Reduction in medicated diurnal IOP
DODT/SODT arm will be evaluated separately
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03374553
Brief Title
MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
November 25, 2017 (Actual)
Primary Completion Date
January 17, 2019 (Actual)
Study Completion Date
February 8, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
iSTAR Medical
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Open Angle Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
26 patients enrolled into first arm, when enrolment completed, an additional 26 patients enrolled into second arm
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MINIject DO Integrated System CS636 (MINI DO636)
Arm Type
Experimental
Arm Description
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).
Arm Title
MINIject SO Integrated System CS636 (MINI SO636)
Arm Type
Experimental
Arm Description
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).
Intervention Type
Device
Intervention Name(s)
MINI DO636
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
MINI SO636
Intervention Description
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).
Primary Outcome Measure Information:
Title
Reduction in medicated diurnal IOP
Description
DODT/SODT arm will be evaluated separately
Time Frame
6 months after surgery
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 (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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zubair Hussain, PhD
Organizational Affiliation
iSTAR Medical
Official's Role
Study Director
Facility Information:
Facility Name
Clínica Oftalmológica del Caribe
City
Barranquilla
Country
Colombia
Facility Name
Maxivision Eye Hospital
City
Hyderabad
State/Province
Telangana
ZIP/Postal Code
500034
Country
India
Facility Name
Panama Eye Center
City
Panama city
Country
Panama
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
MINIject 636 in Patients With Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications
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