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CTRI Number  CTRI/2021/02/030922 [Registered on: 02/02/2021] Trial Registered Prospectively
Last Modified On: 22/04/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Medical Device 
Study Design  Single Arm Study 
Public Title of Study   Study for Reduction of Eye Pressure 
Scientific Title of Study   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 MODIFIED SINGLE OPERATOR DELIVERY SYSTEM 
Trial Acronym  ISM10 
Secondary IDs if Any  
Secondary ID  Identifier 
2020/ISM10 Version 1.0 15 June 2020  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Kasu Prasad Reddy 
Designation  Chief Consultant, Cataract and Refractive Surgery 
Affiliation  Maxivision Super Speciality Eye Hospital 
Address  Cataract Department Room No. 1 6-3-903/A/1/1 Behind Yashoda Hospital Somajiguda Hyderabad India

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  kasuprasadreddy@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kasu Prasad Reddy 
Designation  Chief Consultant, Cataract and Refractive Surgery 
Affiliation  Maxivision Super Speciality Eye Hospital 
Address  Cataract Department Room No. 1 6-3-903/A/1/1 Behind Yashoda Hospital Somajiguda Hyderabad India

Hyderabad
TELANGANA
500082
India 
Phone    
Fax    
Email  kasuprasadreddy@gmail.com  
 
Details of Contact Person
Public Query  
Name  Naresh Kumar Pagidimarry 
Designation  CEO and M D 
Affiliation  8C Healthcare Private Limited 
Address  Clinical Research and Development Room No. 01 1207 13th Street Vijaya Bank Road Gandhinagar Hyderabad India Hyderabad

Hyderabad
TELANGANA
500080
India 
Phone    
Fax    
Email  naresh.pagidimarry@8chealthcare.com  
 
Source of Monetary or Material Support  
iSTAR Medical SA 
 
Primary Sponsor  
Name  iSTAR Medical SA 
Address  Avenue Sabin, 6 1300 Wavre Belgium 
Type of Sponsor  Other [Medical Device Company] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     Colombia
India
Panama  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Kasu Prasad Reddy  Maxivision Super Speciality Eye Hospital  Glaucoma Department, 6-3-903/A/1/1, Behind Yashoda Hospital Somajiguda Hyderabad ANDHRA PRADESH Hyderabad
Hyderabad
TELANGANA 		 9848046919

kasuprasadreddy@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
STAR Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H401||Open-angle glaucoma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  MINI SO627  Glaucoma Drainage Device to reduce Intra Ocular Pressure 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.Males or females, 18 years of age or older.
2.Diagnosis of primary or secondary open angle glaucoma during screening/baseline visit or earlier.
3.Grade 3 (open, 20‐35 degrees) or grade 4 (wide open, 35‐45 degrees) according to Shaffer Angle Grading System.
4. 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.
5. Patients must be willing and able to return for scheduled study‐related examinations.
6. Patients must provide written informed consent. 
 
ExclusionCriteria 
Details  1. 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.
2. Neovascular glaucoma in the study eye.
3. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant in the stud eye.
4. Prior glaucoma surgery in the study eye. Patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye are eligible if treatment was performed ≥ 90 days before baseline visit in the study eye.
5. Visual field defect in the 10‐degree central field in the study eye.
6. Any eye surgery that was performed < 90 days before baseline visit in the study eye.
7. Anticipated need for ocular surgery or retinal laser procedure in the study eye 12 months following surgery in the study eye.
8. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
9. Pre‐existing ocular or systemic pathology that, in the opinion of the physician, is likely to cause postoperative complications following implantation of the device in the study eye.
10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
11. Evidence of crystalline lens subluxation or luxation in the study eye.
12. Evidence of vitreous loss in the anterior chamber in the study eye.
13. Clinically significant intra‐ocular inflammation or infection, presence of ocular disease such as
uveitis, ocular infection, severe dry eye, severe blepharitis, active proliferative/inflammatory retinopathy in the study eye.
14. Presence of silicone oil in the study eye.
15. Patients treated with systemic acetazolamide within 3 days before screening/baseline visit.
16. Patient with poor vision score: +1.0 in non‐study eye, unless there is an expected benefit for the
study eye in the opinion of the investigator.
17. Participation in any study involving an investigational drug or device within the past 3 months
and planned participation to any other study during the present study.
18. Only for women of childbearing potential: positive blood pregnancy test at baseline visit.
19. Individuals under tutorship or trusteeship. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary objective of the study is to show a greater than 20% reduction in medicated diurnal IOP between baseline visit and diurnal IOP 6 months after surgery with or without the use of concomitant use of IOP‐lowering medications.  6 months post surgery 
 
Secondary Outcome  
Outcome  TimePoints 
1.To test the absolute and relative (in %) reduction in medicated or unmedicated (without washout) diurnal IOP between baseline visit and medicated diurnal IOP at 12‐ and 24 months after surgery.
2.To assess the safety of the MINIject in terms of nature and severity of AE/SAE, ADE/SADE, DDs and UADEs. Data can be pooled with other trials to compare the safety of SODT and SODT to implant MINIject glaucoma implant. 		 6, 12, 24 months post surgery 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="15" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/02/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  10/02/2021 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Closed to Recruitment of Participants 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   Not Yet 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  
The aim of this study is to assess the efficacy and safety of the MINIject system (i.e. MINI SO627) in patients diagnosed with primary open angle glaucoma uncontrolled by topical hypotensive medications.
MINIject is intended to be used to reduce the intraocular pressure (IOP) by channeling aqueous humour out of the anterior chamber to a sub‐scleral location, thus enhancing the physiological uveoscleral outflow.
 
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