| CTRI Number |
CTRI/2023/10/059113 [Registered on: 25/10/2023] Trial Registered Prospectively |
| Last Modified On: |
19/06/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Biological |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
To assess the ability of retina specialists to successfully administer Aflibercept in eye. |
|
Scientific Title of Study
|
A Multi-Center Study to Evaluate Ocular Safety and Effective Administration of MYL-1701P Pre-filled Syringe in Patients with Conditions requiring Intravitreal Aflibercept. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| AFIL-IJZ-3003, Version 01, 04/12/2021 |
Protocol Number |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)
|
| Name |
Dr Ankitkumar Ranpura |
| Designation |
Senior Director |
| Affiliation |
Biocon Biologic Limited, |
| Address |
Biocon Biologic Limited, Electronic City, Bangalore 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
8460062870 |
| Fax |
|
| Email |
ankitkumar.ranpura@biocon.com |
|
Details of Contact Person
Scientific Query
Modification(s)
|
| Name |
Dr Ankitkumar Ranpura |
| Designation |
Senior Director |
| Affiliation |
Biocon Biologic Limited, |
| Address |
Biocon Biologic Limited, Electronic City, Bangalore 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
8460062870 |
| Fax |
|
| Email |
ankitkumar.ranpura@biocon.com |
|
Details of Contact Person
Public Query
|
| Name |
Jayanti Panda |
| Designation |
Senior Director |
| Affiliation |
Biocon Biologic Limited |
| Address |
Biocon Biologic Limited, Electronic City, Bangalore 560100
Bangalore
KARNATAKA
560100
India |
| Phone |
08067755304 |
| Fax |
|
| Email |
Jayanti.Panda@biocon.com |
|
|
Source of Monetary or Material Support
|
| BCIL ( Biosimilar collaborations Ireland Limited) |
|
|
Primary Sponsor
|
| Name |
Biosimilar collaborations Ireland Limited |
| Address |
Unit 35/36, Grange Parade,
Baldoyle Industrial Estate,
Dublin 13, Dublin,
Ireland, D13 R20R
|
| Type of Sponsor |
Pharmaceutical industry-Global |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India
United States of America |
Sites of Study
Modification(s)
|
| No of Sites = 5 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sribhargava Natesh |
Dr Sribhargava Natesh |
Consultation 4
2 Floor Retina Department
Nethra Eye Hospital No. 8 Poojary Layout 80Ft Road, R.M.V
2 Stage Sanjaynagar
Bangalore 560094
Bangalore
KARNATAKA |
09900012800
sribhargava.natesh@gmail.com |
| Dr Lional Raj |
Dr. Agarwal’s Eye Hospital, |
No. 15, South Bypass Road, Vannarpettai, Tirunelveli-627003, Tamil Nadu, India
Tirunelveli
TAMIL NADU |
8754411261
drlionalraj@dragarwal.com |
| Dr Haard Shah |
LG Municipal General Hospital, |
Narendra Modi Medical College, Near Rambaug, Maninagar, Ahmedabad – 380008, India
Ahmadabad
GUJARAT |
9979545854
haardshah25@gmail.com |
| Dr Somesh Aggarwal |
M and J Western Regional Institute of Ophthalmology |
First Floor Department of Retina M and J Western Regional Institute of Ophthalmology associated with B.J. Medical college and Civil Hospital Aswara Ahmedabad 380016 Gujarat India
Ahmadabad
GUJARAT |
07922680314
dr.somesh@yahoo.com |
| Dr Rohan Chauhan |
Rising Retina Clinic |
Rising Retina Clinic
312 and 313 Iscon Centre
Shivranjani Cross Roads
Satellite Ahmedabad 380015
Gujarat India.
Ahmadabad
GUJARAT |
07926925232
rohan_28782@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 5 |
| Name of Committee |
Approval Status |
| AMC MET Ethics Committee |
Approved |
| B.J. Medical College and Civil Hospital Institutional Ethics Committee |
Approved |
| Dr. Agarwals Eye Hospital Institutional Review Board |
Approved |
| Pranav Diabetic Center Ethics Committee |
Approved |
| Ridhi Medical Nursing Home Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: H36||Retinal disorders in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MYL-1701P Pre-filled Syringe |
Subjects will receive 1 dose of 2 mg at Baseline through intravitreal injection |
| Comparator Agent |
Not applicable |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Male or female subject ≥18 years of age who have nAMD, DME,
macular edema following RVO, or DR in the study eye.
2. Study eye requires treatment with aflibercept as per Investigator’s
discretion.
3. If female of childbearing potential, the subject must have a
negative urine pregnancy test at the screening and baseline visits
and should not be nursing or planning a pregnancy.
4. If female, subject must be:
a. Surgically sterilized via hysterectomy, bilateral
oophorectomy, or bilateral tubal ligation; or
b. Of childbearing potential and practicing an acceptable
form of birth control (defined as the use of an intrauterine
device; a barrier method, like condom, with spermicide;
any form of hormonal contraceptives; or abstinence from
sexual intercourse) starting from screening and continuing
at least 90 days following the study drug administration.
c. Of non-childbearing potential (i.e., post-menopausal for at
least 1 year).
5. If male, subject must be surgically or biologically sterile. If not
sterile, the subject must agree to use an acceptable form of birth
control with sexual partner (as described in inclusion criteria #4b)
or abstain from sexual relations during the study period and up to
90 days following the study drug administration.
6. Subject is willing to comply with the study visits and study
related procedures.
7. Subject is able to understand and voluntarily provide written
informed consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
Subjects who meet any of the following criteria will be excluded from the study:
1. Subject with known hypersensitivity to aflibercept or any of the excipients in MYL-1701P.
2. Subject on treatment with any intravitreal injection in the study eye within the 28 days prior to Day 1.
3. Subject with intraocular pressure ≥ 25 mmHg in study eye.
4. Subject with any intraocular surgery in the study eye at any time during the past 3 months prior to Day 1.
5. Subject with evidence of active infectious blepharitis, keratitis,
scleritis, or conjunctivitis in either eye.
6. Subject with any active intraocular inflammation or infection in either eye or history of intraocular inflammation or infection after
past intravitreal injections with any agent in either eye.
7. Subject with history of or any current indication of excessive bleeding and recurrent hemorrhages, including any prior
excessive intraocular (including subconjunctival) bleeding or hemorrhages after intravitreal injection or intraocular procedures
in either eye.
8. Subject with clinical diagnosis of uncontrolled glaucoma (defined as intraocular pressure ≥ 25 mmHg despite treatment with antiglaucoma medication).
9. Use of therapies that are known to be toxic to any ocular tissues
(i.e., radiation) in either eye anytime in the past.
10. Subject taking any prior extended-release therapeutic agent, or ocular drug-release device implantation (approved or
investigational including steroids) in the study eye.
11. Subjects with uncontrolled hypertension defined as systolic blood
pressure > 160 mm Hg or diastolic blood pressure > 95 mm of Hg.
12. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment.
13. Subjects with renal failure requiring dialysis or renal transplant.
14. Subject having any concurrent systemic condition or any ocular condition in the study eye which, in the opinion of the investigator, could have either increased the risk to the subject
beyond what was to be expected from standard procedures of intravitreal injections, or which otherwise may have interfered
with the injection procedure or with evaluation of safety.
15. Subject participation in any interventional clinical study within the 12 weeks prior to day 1 of the study.
16. Subject with current systemic infectious disease or a therapy foractive infectious disease.
17. Subject who has only one functional eye, even if the eye met all other study requirements, or who has an ocular condition on the
fellow eye with a poorer prognosis than the study eye.
18. Current known active infection of coronavirus disease 2019 (COVID-19), or subjects with an increased risk of serious COVID-19 related morbidity as determined by the investigator at
the time of screening and/or enrollment; subjects who have had previous COVID-19 infections but have recovered by the time of enrollment visit may be enrolled if there are no current COVID-19 symptoms as determined by the investigator; subjects
who had previously received COVID-19 vaccine may be enrolled irrespective of the timing of vaccination. (Additional COVID-19 screening procedures that may be mandated by the study site do not need to be reported as protocol deviations).
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Incidence of Treatment emergent adverse
events (TEAEs).
|
day 8
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The secondary objective is to determine if the presentation MYL-1701P
PFS can be used effectively by Ophthalmologists to administer the 2 mg
dose of MYL-1701P.
|
1 Day |
|
|
Target Sample Size
|
Total Sample Size="35"
Sample Size from India="35"
Final Enrollment numbers achieved (Total)= "35"
Final Enrollment numbers achieved (India)="35" |
|
Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
17/04/2024 |
| Date of Study Completion (India) |
22/05/2024 |
| Date of First Enrollment (Global) |
17/04/2024 |
| Date of Study Completion (Global) |
22/05/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is designed to evaluate the
ocular safety of MYL-1701P administered through PFS and to evaluate whether the
intravitreal administration can be effectively performed using the PFS.
Subjects participating in this study will receive 1 doses of MYL-1701P, The
total study duration will be 28 days. |