CTRI/2020/11/028961 [Registered on: 06/11/2020] Trial Registered Prospectively
Last Modified On:
21/12/2023
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Single Arm Study
Public Title of Study
An extension clinical trial to study the effects of investigational medicine MYL-1701P in patients with Diabetic Macular Edema
Scientific Title of Study
A Multi center, Extension Study to Evaluate the Safety and Efficacy of MYL-1701P in Subjects with Diabetic Macular Edema Completed MYL-1701P-3001 Study.
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
AFIL-IJZ-3002,Version 01,Date: 19 Aug 2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Prasanna C Ganapathi
Designation
Associate Vice President – Global Clinical Sciences
Affiliation
Mylan Pharmaceuticals Pvt Ltd.
Address
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 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 Madurai TAMIL NADU
91-4524356100
cauveryeye@gmail.com
Dr Lional Raj
Dr. Agarwals Eye Hospital
Dept of Ophthalmology,
Room No. 38, 3rd floor,
No.10, South Bypass road, Vannarpettai,
Tirunelveli Tirunelveli TAMIL NADU
E-3A, Sector 26 Noida Gautam Buddha Nagar UTTAR PRADESH
01202477600
Shahana.mazumdar@gmail.com
Dr Raja Narayana
L V Prasad eye Institute
Director and Network head Clinical research, L V Prasad Eye Institute, Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills road No 2, Hyderabad 500034, Telangana, India Hyderabad TELANGANA
Dept of Ophthalmology, Research room, 1st floor, GMR Varalakshmi Campus Hanumanthawaka Junction Visakhapatnam ANDHRA PRADESH
91-7416434031
bhavik@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 Ahmadabad GUJARAT
Subjects will receive 3 doses each of 2 mg at 8 weeks interval
Comparator Agent
NIL
NIL
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1.Subject participated in the MYL-1701P-3001 study
2.Subject requires treatment with intravitreal anti-VEGF therapy
3.Subject is able to understand and voluntarily provide written informed consent to participate in the study.
4.If female of childbearing potential, the subject must have negative pregnancy tests and should not be nursing or planning a pregnancy.
5.Subject is willing to comply with the study duration, study visits and study related procedures.
6.If female, subject must be:
•Surgically sterilized via hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; or
•Of childbearing potential and practicing an acceptable form of birth control
•Of non-childbearing potential
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
ExclusionCriteria
Details
1. Subjects with known hypersensitivity to aflibercept or any of the excipients
2. Subjects will be excluded if any of the following conditions are met in the study eye:
• Subjects with active ocular inflammation.
• Subjects with uncontrolled glaucoma
• Surgery for glaucoma in the past or likely to be needed in the future.
3. Subjects with active or suspected ocular or periocular infection including but not limited to infectious blepharitis, keratitis, scleritis, or conjunctivitis in either eye.
4. Subjects who plan to participate in another clinical study while enrolled in this study.
5. Subjects receiving treatment for a serious systemic infection.
6. Subjects with uncontrolled hypertension defined as systolic blood pressure > 160 mm Hg or diastolic blood pressure > 95 mm Hg.
7. Subjects with a history of cerebrovascular accident or myocardial infarction within 6 months of enrollment visit.
8. Subjects with renal failure requiring dialysis or renal transplant.
9. Subjects with a history or presence of any clinically significant condition, that in the opinion of the Investigator would jeopardize the safety of the subject or the validity of the study results
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Incidence of Treatment emergent adverse events (TEAEs).
Week 24
Secondary Outcome
Outcome
TimePoints
Change from baseline in BCVA
Week 20
Change from baseline in CRT
Weeks 8, 16 and 20
Target Sample Size
Total Sample Size="70" Sample Size from India="70" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This Extension Study
(AFIL-IJZ-3002) is designed to evaluate the safety, efficacy and immunogenicity
of MYL-1701P among a group of participants successfully completing
MYL-1701P-3001. Subjects participating in this study will receive 3 doses of
MYL-1701P, every 8 weeks. The total study duration will be 24 weeks.