| CTRI Number |
CTRI/2018/02/012240 [Registered on: 28/02/2018] Trial Registered Retrospectively |
| 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, Multicenter Clinical Trial analyzing the Effectiveness and Safety of MINIject-636 in Patients with Open Angle Glaucoma uncontrolled by Topical Hypotensive Medications |
| Trial Acronym |
|
Secondary IDs if Any
Modification(s)
|
| Secondary ID |
Identifier |
| 2018/ISM05/AM1 Version 2.0 dated March 30, 2018 |
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 |
Department of Glaucoma
Room No. 206
6-3-903/A/1/1, Behind Yashoda Hospital, Somajiguda
Hyderabad
ANDHRA PRADESH
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 |
Department of Glaucoma
Room No. 206
6-3-903/A/1/1, Behind Yashoda Hospital, Somajiguda
Hyderabad
ANDHRA PRADESH
500082
India |
| Phone |
|
| Fax |
|
| Email |
kasuprasadreddy@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr Naresh Kumar Pagidimarry |
| Designation |
CEO and M D |
| Affiliation |
8C Healthcare Pvt. Ltd. |
| Address |
Department of Clinical Research
Room No. 1
1207, 13th Street, Vijaya Bank Road, Gandhinagar
Hyderabad
ANDHRA PRADESH
500080
India |
| Phone |
|
| Fax |
|
| Email |
naresh.pagidimarry@8chealthcare.com |
|
|
Source of Monetary or Material Support
|
| iSTAR Medical SA
Avenue Sabin 6,
1300 Wavre,
Belgium |
|
|
Primary Sponsor
|
| Name |
iSTAR Medical SA |
| Address |
Avenue Sabin, 6
1300 Wavre
Belgium |
| Type of Sponsor |
Other [Medical Device Company] |
|
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
Modification(s)
|
India
Panama
Colombia |
|
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 |
9848046919
kasuprasadreddy@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| STAR Institutional Ethics Committee |
Approved |
| STAR Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Patients with Open Angle Glaucoma Uncontrolled by Topical Hypotensive Medications, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MINIject-636 |
MINIject-636 is an integrated system comprising a minimally-invasive Glaucoma Drainage Implant and a Delivery Tool. Patients will be followed up for 24 months |
| 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 21 mmHg ≤ IOP ≤ 35 mmHg in the study eye at screening and baseline visits.
5. Patient must be willing and able to return for scheduled study-related examinations.
6. Patient must provide written informed consent.
|
|
| ExclusionCriteria |
| Details |
1. Diagnosis of glaucoma other than open angle glaucoma (e.g. angle closure glaucoma) in the study eye.
2. 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.
3. Neovascular glaucoma in the study eye.
4. Corneal opacity or iridocorneal angle not visible through gonioprism in the study eye, preventing correct placement of the implant.
5. Prior eye surgery in the study eye within 90 days before screening visit.
6. Prior glaucoma surgery in the study eye, except patient treated with argon laser trabeculoplasty or selective laser trabeculoplasty in the study eye may be eligible if treatment performed ≥ 90 days before screening visit.
7. Visual field defect in the 10 degree central field in the study eye.
8. Anticipated need for ocular surgery or retinal laser procedure in the study eye in the 12 months following surgery.
9. Anterior chamber anatomic configuration of high risk for development of angle closure glaucoma in the study eye.
10. Clinically significant corneal disease (e.g., corneal dystrophy) in the study eye.
11. 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.
12. Evidence of crystalline lens subluxation or luxation in the study eye.
13. Evidence of vitreous loss in the anterior chamber in the study eye.
14. 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.
15. Presence of silicone oil in the study eye.
16. Patients treated with systemic acetazolamide within 3 days before screening visit.
17. Patients with poor vision (LogMAR score: +1.0) in non-study eye, unless there is an expected benefit for the study eye, in the opinion of the investigator.
18. Participation in any study involving an investigational drug or device within the past 3 Months.
19. Only for women of childbearing potential: positive urine pregnancy test at screening.
20. 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 |
| Reduction in medicated mean diurnal IOP at 6 months follow-up compared to medicated diurnal IOP at screening visit |
6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Absolute and relative reduction (in %) of medicated diurnal IOP compared to medicated diurnal IOP at screening visit. |
Day 1, Week 1, Week 2, Month 1, Month 3, Month 6, Month 12, Month 18, Month 24 |
|
Target Sample Size
Modification(s)
|
Total Sample Size="50"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "50"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
29/11/2017 |
| Date of Study Completion (India) |
10/01/2022 |
| Date of First Enrollment (Global) |
27/11/2017 |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The aim of this study is to assess the efficacy and safety
of the MINIject-636 system in patients diagnosed with open angle glaucoma
uncontrolled by topical hypotensive medications. MINIject is intended to
be used to reduce the intraocular pressure (IOP) by channelling aqueous
humour out of the anterior chamber to a sub-scleral location, thus
enhancing the physiological uveoscleral outflow. MINIject is
indicated in adult, male and female patients diagnosed with primary or
secondary open angle glaucoma, and where the progression of glaucoma is
not adequately controlled by topical hypotensive medication(s). MINIject
is an integrated system comprising a minimally-invasive Glaucoma
Drainage Implant and a Delivery Tool. The Delivery Tool is configured
for inserting the implant into the sub-scleral location through an
ab-interno minimally-invasive approach. The delivery tool is single-use. The intervention is to be performed as stand-alone surgery. |