MINIject in Patients With Open Angle Glaucoma Using Single Operator Delivery Tool
A Prospective, Open, Multicentre 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
1 other identifier
interventional
25
3 countries
3
Brief Summary
Study to assess safety and performance of MINIject SO627 in patients with open angle glaucoma.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2019
Typical duration for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 21, 2019
CompletedFirst Posted
Study publicly available on registry
June 24, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 14, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 10, 2022
CompletedMay 3, 2023
May 1, 2023
7 months
June 21, 2019
May 2, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
medicated diurnal IOP
Change in medicated diurnal IOP
6 months post surgery
Study Arms (1)
MINIject CS627 implant
EXPERIMENTALMINIject 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.
Interventions
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.
Eligibility Criteria
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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- iSTAR Medicallead
Study Sites (3)
Clinica Oftalmologica del Caribe
Barranquilla, Colombia
Maxivision Eye Hospital
Hyderabad, Telangana, 500034, India
Panama Eye Center
Panama City, Panama
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Zubair Hussain, PhD
iSTAR
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 21, 2019
First Posted
June 24, 2019
Study Start
July 23, 2019
Primary Completion
February 14, 2020
Study Completion
February 10, 2022
Last Updated
May 3, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share