CTRI/2019/09/021202 [Registered on: 12/09/2019] Trial Registered Prospectively
Last Modified On:
26/02/2022
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
Comparative Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects With Diabetic Macular Edema
Scientific Title of Study
A Multi Center, Randomized, Double-Masked, Active-Controlled, Comparative Clinical Study to Evaluate the Efficacy and Safety of MYL-1701P and Eylea® in Subjects with Diabetic Macular Edema
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
Identifier: NCT03610646
ClinicalTrials.gov
MYL-1701P-3001, India Local Amendment V 1.0, dated 12 Jun 19
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Prasanna C Ganapathi MD
Designation
Head of Global Clinical strategy and Innovation
Affiliation
Mylan Pharmaceuticals Pvt Ltd.
Address
Mylan Pharmaceuticals Pvt Ltd., Prestige Platina, Block 3, Kadubeesanahalli Village, Outer Ring Road, Bangalore
Dept of Ophthalmology, Room No. 480, 4th floor, Dr.Rajendra Prasad Centre for Opthalmic Sciences, AIIMS Campus, Sri Aurobindo Marg, Ansari Nagar, Ansari Nagar East, New Delhi-110029, Delhi, India New Delhi DELHI
91-9818598899
vohrarajpal@gmail.com
Dr Naresh Babu Kannan
Aravind Eye Hospital
Dept of Ophthalmology, Room No. 207, 2nd floor, Aravind Eye Hospital & Postgraduate Institute of Ophthalmology,
No.1 Anna Nagar, Madurai – 625020, Tamil Nadu, India
Madurai TAMIL NADU
91-4524356100
cauveryeye@gmail.com
Dr Veerappan R Saravanan
Arvind Eye Hospital
Avinashi road, Civil Aerodrome Post Coimbatore TAMIL NADU
91-9244401310
saravananvr@gmail.com
Dr Lional Raj
Dr. Agarwals Eye Hospital
Dept of Ophthalmology, Room No. 38, 3rd floor, No.10, South Bypass road, Vannarpettai, Tirunelveli-627002, Tamilnadu, India Tirunelveli TAMIL NADU
Dept of Ophthalmology, OPD room, Ground floor, Mithu Tulsi Chanrai Campus,
Patia, Bhubaneswar-751024 Odisha, India
Khordha ORISSA
91-9853011697
umesh@lvpei.org
Dr Bhavik Panchal
LV Prasad Eye Institute
Dept of Ophthalmology, Research room, 1st floor, GMR Varalakshmi Campus
Hanumanthawaka Junction
Visakhapatnam-530 040, Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH
8639145521
bhavik@lvpei.org
Dr Raja Narayana
LV Prasad Eye Institute
Dept of Ophthalmology, Room No. 123, 1st floor, Kallam Anji Reddy Campus,
L.V Prasad Marg, Banjara Hills, Road No: 2,
Hyderabad-500034,
Telangana, India
Hyderabad TELANGANA
9177111975
narayanan@lvpei.org
Dr Somesh Aggarwal
M&J Western Regional Institute of Ophthalmology
Department of Retina,Room No. 126, First floor, M & J Western Regional Institute of Ophthalmology, Nr. Baliya Limbdi cross road, Opp. Indian Oil Petrol Pump, Asarwa, Ahmedabad- 380016,
Gujarat, India.
Ahmadabad GUJARAT
91-9427029044
dr.somesh@yahoo.com
Dr Naresh Kumar Yadav
Narayana Nethralaya
Dept of Ophthalmology, OPD Room, B -Block, Basement, #121/C Chord Road,
1st ‘R’ Block, Rajaji Nagar,
Bangalore -560010, Karnataka, India
Bangalore KARNATAKA
91-8066121463
vasudha.naresh@gmail.com
Dr Sribhargava Natesh
Nethra Eye Hospital
Dept of Ophthalmology, Room No. 4 & 5, 2nd floor, Drishtidhama Hospitals Pvt Ltd, No. 8, 80 Feet Road, Sanjaynagar, RMV Second Stage, Bangalore- 560094, Karnataka, India Bangalore KARNATAKA
91-9342880273
sribhargava.natesh@gmail.com
Dr Vishali Gupta
PGIMER
Dept of Ophthalmology, Room No. 242, 2nd floor, Advance Eye Centre ,PGIMER Chandigarh , 160012, India Chandigarh CHANDIGARH
91-9417565506
vishalisara@gmail.com
Dr Rohan Chauhan
Rising Retina Clinic
Rising Retina Clinic, 312-313, Iscon Centre, Shivranjani Cross Roads, Satellite, Ahmedabad- 380015, Gujarat, India Ahmadabad GUJARAT
91-9727950600
rohan_28782@yahoo.co.in
Dr Arti Elhence
Sam Eye Hospital
Dept of Ophthalmology, Dr. Arti Elhence Chamber, Basement, Dr. Subodh Agarwal memorial Eye Care Pvt Ltd, 21/31, Tilak Marg, Hazratganj, Lucknow- 226010, Uttar Pradesh, India Lucknow UTTAR PRADESH
91-9415010741
sameyelko@gmail.com
Dr Minija CK
Sankara Eye Hospital
Dept of Ophthalmology, Room No. 28, Ground floor, Varthur Rd, Gate, Lakshminarayana Pura, Kundalahalli, Munnekollal, Bengaluru-560037, Karnataka, India Bangalore KARNATAKA
91-9480587018
minija_ck@yahoo.co.in
Dr Rahul Shroff
Shroff Eye Hospital & Vision Research Centre
Dept of Ophthalmology, Room No. 1 & 2, 1st floor, 222, S.V.Road, Near Suburbia Movie Theatre, Bandra (W), Mumbai - 400050, Maharashtra, India
Mumbai MAHARASHTRA
2 mg every 4 weeks for a total of 5 injections, and then every 8 weeks through the remainder of the 52-week treatment period, with the last dose at 48 weeks
Intervention
MYL-1701P
2 mg every 4 weeks for a total of 5 injections, and then every 8 weeks through the remainder of the 52-week treatment period, with the last dose at 48 weeks
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Male or female subjects age more than or equal to 18 years.
2.Subjects have type 1 or type 2 diabetes mellitus who present with central DME involvement in the study eye.
3.The cause of decreased vision in the study eye has been attributed primarily to DME by the Investigator.
4.Subject is able to understand and voluntarily provide written informed consent to participate in the study.
5.If female of child bearing potential, the subject must have a negative serum pregnancy test at the Screening visit and a negative urine pregnancy test at baseline visit, and should not be nursing or planning a pregnancy.
6.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 60 days prior to dosing and continuing at least 90 days following the last treatment.
c.Of non-childbearing potential (i.e., postmenopausal for at least 1year).
7.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 #6b of protocol) or abstain from sexual relations during the study period and up to 90 days following the last treatment dose.
8.Subject is willing to comply with the study duration, study visits and study related procedures.
ExclusionCriteria
Details
1.Subjects with known hypersensitivity to aflibercept or any of the excipients
2.Subjects with current or planned use of systemic medications known to be toxic to the lens, retina or optic nerve, including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines and ethambutol
3.Subjects with uncontrolled hypertension defined as systolic blood pressure >160mm Hg or diastolic blood pressure > 95 mm of Hg.
4.Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of randomization.
5. Subjects with a clinical diagnosis of glaucoma (controlled or uncontrolled)
6.Subjects who have only one functional eye, even if the eye met all other study requirements, or who have an ocular condition on the fellow eye with a poorer prognosis than the study eye.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator and Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Primary Endpoints: The mean change from baseline in BCVA at week 8
8 week
Secondary Outcome
Outcome
TimePoints
Secondary Endpoints
1.The mean change from baseline in CRT over time
2.The mean change in BCVA over time
3.Proportion of subjects who gained ≥15 letters from Baseline in BCVA letters over time.
4.Number of administrations of study drug required
5.Incidence of treatment emergent adverse events (Safety and tolerability)
6.Proportion of subjects testing positive for Anti-Drug Antibodies (ADA) (Immunogenicity )
7.Concentration of aflibercept in blood (Pharmacokinetics)
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
Three hundred and twenty-four (324) eligible adult subjects with diabetes mellitus with central DME involvement will be randomized 1:1 to intravitreal treatment with MYL-1701P or Eylea®. Subjects will receive the assigned treatment until Week 48.
All subjects will return to clinic every 4 weeks to assess safety, efficacy and to guide treatment. There will be additional visits during the study as specified in the study schedule for safety and pharmacokinetic evaluation.
Pharmacokinetics (PK) and Immunogenicity will be assessed in the subjects participating in the study.