CTRI/2024/11/077362 [Registered on: 26/11/2024] Trial Registered Prospectively
Last Modified On:
28/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
To compare the efficacy, safety, and immunogenicity of Aflibercept of Shilpa Biologicals Private Limited (SBPL) with EYLEA® (Aflibercept) of Bayer AG in Wet AMD subjects
Scientific Title of Study
A prospective, multi-centre, randomized, double blind, parallel, active controlled, phase III study to compare the efficacy, safety, and immunogenicity of Aflibercept of Shilpa Biologicals Private Limited (SBPL) with EYLEA® (Aflibercept) of Bayer AG in subjects with Neovascular Age-related Macular Degeneration (Wet AMD)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CBCC/2022/011,Version: 4.1, dated 20.06.2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Ward no 3, Clinical Research department, behind psychiatry ward, Acharya Vinoba Bhava Rural Hospital, Sawangi (Meghe), Wardha 442004, Maharashtra, India. Wardha MAHARASHTRA
8097497803
drarchana8030@gmail.com
Dr Vandana Akshay Iyer
All India Institute of Medical Sciences
Room Number 453, 4th Floor, Department of Ophthalmology, Plot No. 2, Sector-20, MIHAN, Sumthana, Nagpur, Maharashtra-441108 India. Nagpur MAHARASHTRA
9962253382
lalit1171985@gmail.com
Dr Ajay Kartik Ambade
Ambade Eye Hospital
Research Room - Second floor, Kamla Tower, Kamptee, Near Jaswant Inox, Near Indora Chowk, Nagpur, Maharshtra-440002, India. Nagpur MAHARASHTRA
9823178466
dr_ajayambade@rediffmail.com
Dr Naresh Babu Kannan
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology
Aravind Eye Hospital and Postgraduate Institute of Ophthalmology, Room No 1, 1st floor, No. 1 Anna Nagar, Madurai - 625 020, Tamil Nadu, India Madurai TAMIL NADU
914524356100
cauveryeye@gmail.com
Dr Sandeep B Patil
Belgavi Institute of Medical Science
Room Number 38, Ground Floor, Opthomology OPD Department, Dr B R Ambedkar Road, Sadashiv Nagar, Belgavi-590001, Karnataka, India. Belgaum KARNATAKA
9945447572
drsandeepatil@gmail.com
Dr Anup Vijaykumar Shah
Chopda Medicare & Resarch Centre Pvt. Ltd
OPD 2, Mezzanine Floor, Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute, 3/5, Patil Lane No. 1, Laxmi Nagar, Near K.B.H. Vidyalaya, Canada Corner, Nashik-422005, Maharashtra, India Nashik MAHARASHTRA
9850501495
dranupshah@gmail.com
Dr Prakash Vilakumdathil Surendranath
Comtrust Charitable Trust Eye Hospital
Room No 35, Ground floor, Dept of ophthalmology, Puthiyara, Calicut-673004, Kerala, India Kozhikode KERALA
8921032572
prakashvresearch@gmail.com
Dr Punit Kumar Singh
Dhiraj Hospital, SBKS MI & RC, Sumandeep Vidyapeeth
Dhiraj Hospital, SBKS MI & RC, Sumandeep Vidyapeeth, Deemed to be University, At and PO.Piparia, Taluka: Waghodia,Vadodra - 391760, Gujarat, India Vadodara GUJARAT
Disha Eye Hospitals Pvt Ltd 88(63A), Goshpara Road, Barrackpore, Kolkatta, 700120, West Bengal, India Kolkata WEST BENGAL
9748303688
drdineshrungta5@gmail.com
Dr Nilesh Bhausaheb Chakne
Dr. Chakne Eye and Children Hospital
room no 4, 2nd floor,Chinchwad,Pune,Maharashtra 411027 Pune MAHARASHTRA
7875989088
drnileshchakne@gmail.com
Dr Vinod Kumar
Dr. Rajendra Prasad Centre for Ophthalmic Sciences
room no 1, Eye consultancy department, Dr. Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, Delhi, 110029, India New Delhi DELHI
Clinical Trial Unit (CTU), 2nd floor, krishna Institute of Medical
Krishna Institute of Medical Sciences (KIMS), Karad
Address: NH-4, Pune–Bangalore Highway, Malkapur, Karad,
District – Satara, Maharashtra, India – 415539 Satara MAHARASHTRA
9764812911
drgauravparanjpe@gmail.com
Dr Priyank Garg
LLRM Medical College, Meerut
LLRM Medical College, Garh Road, Meerut - 250004, Uttar Pradesh, India Meerut UTTAR PRADESH
8475002225
drpriyankgarg1999@gmail.com
Dr Ashish Sharma
Lotus Eye Hospital and Institute
Room Number F06, Ist Floor, Department of Optholmology OPD, Avinashi Road, near passport office, Peelamedu, Civil Aerodrome post Coimbatore-641014, Tamil Nadu, India. Coimbatore TAMIL NADU
7356300470
drashishsharmaresearch121@gmail.com
Dr Purvi Raj Bhagat
M&J Institute of ophthalmology
Room Numbe 113,Glaucoma Department, First Floor, Manjushree Mill Compound, Asarwa, Ahmedabad-380016, Gujarat, India. Ahmadabad GUJARAT
9825985265
drpurvi.bhagat@yahoo.com
Dr Shashidhar S
Minto Ophthalmic Hospital and RIO
Room no 216, 2nd floor, department of vitreo retina, Chamrajpet, Tippu Sultan Palace Road, Opp. VV Puram police station, New Tharagupet, Banglore-560002, Karnataka Bangalore KARNATAKA
9845779330
swamyshashidhar@gmail.com
Dr Rohit Sanjay Laul
Modern Eye Hospital
OPD 2, Ground Floor,11-13-G, Suyojit Modern Point, Opposite Police parade ground, Sharanpur, Road, Nashik-4220022, Maharashtra, India Nashik MAHARASHTRA
9656442160
drlaulrs@gmail.com
Dr Sandhya Dharwadkar
Mysore Medical college and research Institute-KR Hospital
Room No. 5, Ground Floor, Department of Opthomology, Irwin Road, Mysore-570001, Karnataka, India. Mysore KARNATAKA
Room No.01,1st floor, KayDee House, Above Union Bank of India. Opp. Gujarat Gas, Parimal Garden Cross Road, CG, Road,Ahmedabad-380006 Ahmadabad GUJARAT
8940291312
netralaya.rch@gmail.com
Dr Mudit Bansal
Netralok Retina Clinic
Room No.01, 3rd floor, Department of opthamalogy,Netralok Retina Clinic, 304-305, Golden Icon, Above Hyundai showroom, Opp medilink hospital, Nr shymal crossroad,132 ft ring road, satellite,Ahmadabad-380015 Ahmadabad GUJARAT
9427045076
drmudhitbansal@gmail.com
Dr Sagar Aghadate
PBMAs H V Desai Eye Hospital
Room no 1, 1st Floor, PBMAs H V Desai Eye Hospital, 93, Tarawade Vasti, Mohammadwadi, Hadapsar, Pune, Maharashtra 411060, India Pune MAHARASHTRA
02026974000
drsagaraghadate@gmail.com
Dr Hegde Sharat Shivaramaiah
Prasad Netralaya, Super Speciality Eye Hospital
Prasad Netralaya, Super Speciality Eye Hospital, A J Alse Road, Behind Alankar Theatre,Udupi,576101 Udupi KARNATAKA
6282725004
drsharat01@yahoo.com
Dr Vasumathy Vedantham
Radhatri Nethralaya
Room Number 1, 1st floor, Dept. of ophthalmology, 12, Hindi Prachara, Sabha Street, T. Nagar, Chennai-600017, Tamil Nadu, India Chennai TAMIL NADU
8078303539
drvasumathyresearch@yahoo.com
Dr Lakshmi Kanta Mondal
Regional Institute of Ophthalmology
Room No-405, 3rd Floor, Regional Institute of Ophthalmology
Besides Calcutta Medical College, gate no 6
88 College Street, College Square, Kolkata-700073,
West Bengal, India Kolkata WEST BENGAL
9830830216
Lakshmi.mondal62@gmail.com
Dr Khushbu Jindal
SMS Medical College and Attached Hospital
Room Number 02, Department of Ophthalmology, Charak Bhawan, OPD Block, Jaipur-302004, Rajasthan, India Jaipur RAJASTHAN
0141-2219112
drkhushbugoyal@gmail.com
Dr Pawan Prasher
Sri Guru Ram Das Institute of Medical Sciences & Research
room No. 1, Department of ophthalmology, Sri Guru Ram Das Institute of Medical Sciences & Research, VPO, Vallah, Mehta Road, Amritsar, Punjab, 143006, India Amritsar PUNJAB
9646104858
pawanprasher@yahoo.com
Dr Swapnil Vidhate
Subhadra Netralaya
Room no. 1, 1st floor, Subhadra Netralaya, Shreeji Bizz World, 4th Floor, Above Kotak Bank, Kathe Lane Signal, Opposite Camel House, Nashik-Pune Highway, Nashik-422002, Maharashtra India Nashik MAHARASHTRA
82201413571
drswapnilv@gmail.com
Dr Jayanta Kuila
Sunayan Advanced Eye Institute
Room no-19, 4th Floor, Salgechia, Railway Station Road, Tamluk, East Medinipur, West Bengal, India, 721636, India. Medinipur WEST BENGAL
(1) ICD-10 Condition: H475||Disorders of other visual pathways,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Aflibercept intravitreal (IVT) injection
Subjects will receive 2 mg (0.05 mL) of SBPL-Aflibercept by intravitreal (IVT)injection on Day 0 and subsequent IVT injection of 2 mg (0.05 mL) on Day 28 and Day 56.
Comparator Agent
EYLEA®
EYLEA® (Aflibercept) intravitreal (IVT) injection of Bayer AG, Germany
Subjects will receive 2 mg (0.05 mL) of EYLEA® (Aflibercept) by IVT injection on Day 0 and subsequent IVT injection of 2 mg (0.05 mL) on Day 28 and Day 56.
Inclusion Criteria
Age From
45.00 Year(s)
Age To
75.00 Year(s)
Gender
Both
Details
1.Male or female participant between 45 and 75 years of age, both inclusive, at the time of screening.
2.Subject with active primary or recurrent subfoveal lesion with CNV (choroidal neovascularization) secondary to AMD in the study eye. (Please note: Only one eye will be considered for study. If both eyes are eligible, the one with the better visual acuity will be selected for treatment unless, based on medical reasons, the investigator deemed the other eye to be more appropriate for treatment. If both eyes have similar visual acuity and similar medical reasons, then right eye will be selected)
3.Subjects having a best corrected visual acuity equivalent to Snellen acuity of 20/40 to 20/320 in the study eye, using Early Treatment Diabetic Retinopathy Study (ETDRS) chart for testing at 4 meters.
4.Central retinal thickness of ≥300 µm in the study eye as measured by SD-OCT at screening.
5.Subjects able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
ExclusionCriteria
Details
1. Prior treatment with verteporfin or photodynamic therapy in the study eye (except for extrafoveal laser photocoagulation in the study eye) and,or non
study eye within past 3 months before study entry.
2. Prior treatment with systemic or intravitreal anti-vascular endothelial growth factor (VEGF) agents within past 6 months before study entry in the study eye.
3. Any prior treatment with systemic or intravitreal anti-VEGF agents in the fellow eye within past 3 months before study entry.
4. Total lesion size grater than 30.5 mm2, including blood, scars, and neovascularization as assessed by fluorescein angiography (FA) in the study eye.
5. Presence of aphakia in study eye.
6. Uncontrolled hypertension defined as systolic blood pressure (BP) grater than 180 mmHg or diastolic BP grater than 100 mmHg under appropriate antihypertensive treatment.
7. Subject with prior treatment within past 3 months before study entry or current treatment with medication which might cause significant detrimental effect in retina i.e., hydroxychloroquine, chloroquine, vigabatrin or amiodarone etc.
8. Prior vitrectomy or laser surgery of the macula (including photodynamic therapy or focal laser photocoagulation) within 1 month before study entry in the study eye.
9. Scar or fibrosis, making up grater than 70percentage of the total lesion in the study eye.
10. Scar, fibrosis, or atrophy involving the centre of the fovea.
11. Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA (disc area) or more involving the centre of fovea in the study eye.
12. History of CNV in either of the two eye due to causes other than AMD such as pathologic myopia (spherical equivalent of 8 diopters or more negative or axial length of 25 mm or more), ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, or multifocal choroiditis in the study.
13. Retinal pigment epithelial tear involving the macula in the study eye.
14. Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 3 months study period or that could contribute to a loss of best corrected visual acuity over the 3 months study period (e.g. diabetic retinopathy, cataract, uncontrolled glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc). The decision regarding exclusion is to be based on the opinion of the investigator.
15. Active intraocular inflammation or ongoing infection in the study eye.
16. Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole of Stage 2 and above in the study eye.
17. Any other retinal pathology i.e. Central retinal vein occlusion (CRVO), Central retinal artery occlusion (CRAO) etc.
18. Subjects found positive for any of the serology test for Hepatitis B Virus (HBV), Hepatitis C Virus (HCV) or Human Immunodeficiency Virus (HIV).
19. Known hypersensitivity to aflibercept or any of the components of study medication.
20. Previous participation in any clinical trial within 1 month before the entry of the study.
21. Any other condition that in the opinion of investigator could hamper participation in the study and suspected or confirmed poor compliance as per
investigators judgment, in completing the trial and follow up that may make it undesirable for the subject to participate in the study.
22. Pregnant women or breast feeding, or planning to become pregnant while enrolled in the study and for 3 months after the last dose of investigational
product.
23. Sexually active subjects and their partners who are of childbearing potential (i.e., neither surgically sterile nor postmenopausal) and not agreeing to use adequate contraception while on study and for 3 months after the last dose of study drug. Male subjects must agree not to donate sperm during study and for 3 months after the last dose of study drug.
Method of Generating Random Sequence
Permuted block randomization, fixed
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Proportion of subjects who loose grater than 15 letters (approximately 3 lines) from baseline visual acuity in the study eye.
Baseline, Visit 5
Secondary Outcome
Outcome
TimePoints
Proportion of subjects who gain grater than or equal 15 letters (approximately 3 lines) from baseline visual acuity in the study eye [Time Frame: Day 84]
Mean change in best corrected visual acuity (BCVA) in the study eye from baseline to end study visit [Time Frame: Day 84]
Proportions of subjects with incidence of Antidrug Antibodies (ADA) [Time Frame: At baseline and Day 84]
Proportions of subjects with treatment-emergent adverse events, adverse events of interest (EOIs), and serious adverse events [Time Frame: Up to Day 84]
Day0 to Day84
Target Sample Size
Total Sample Size="180" Sample Size from India="180" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This is a prospective, multi-centre, randomized, double blind, parallel, active controlled, phase III study.
The study is planned to be conducted in 180 subjects with Neovascular Age related Macular Degeneration (Wet AMD) (in a ratio of 2:1 i.e. 120 subjects with SBPL Aflibercept and 60 subjects with EYLEA® (Aflibercept) arm).
After signing the informed consent form, the subjects will be screened for confirming the eligibility for study participation.
Subjects will be screened for demographics, physical examination, ophthalmic examination, vital signs, medical history, medication history, 12-lead ECG,
laboratory investigations and urine analysis.
Eligible subjects will be randomized in a ratio of 2:1 i.e. SBPL-Aflibercept or EYLEA® (Aflibercept) arm respectively to enter into the treatment period of 8
weeks. All subjects will receive 2 mg (0.05 mL) of IVT injection on Day 0 and subsequent IVT injection of 2 mg (0.05 mL) on Day 28 and Day 56 (a total of 3
doses).
Each subject will be required to visit the site for a total of 05 visits: Visit 1 – screening visit, Visit 2 –Day 0, Visit 3- Day 28, Visit 4- Day 56 and Visit 5- Day 84; End of the study (EOS) visit). Subjects will report to the clinical site (visit) for investigational product administration on Day 0, Day 28 and Day 56. A window period of ± 2 days is allowed at visit 3, visit 4 and visit 5.
After receiving the last dose of investigational product, subjects will be followed up for a period of 4 weeks and End of Study Assessment will be performed on Day 84.
Each trial subject who requires treatment in the fellow eye as per investigator’s discretion during the study, will be provided standard of care treatment other than anti-VEGF therapy which do not interfere with the endpoint analysis of the study.
The post-trial access of the study drug - test product will be provided free of cost by the sponsor to all the trial subjects, to be taken for 4 to 6 cycles after completion of the trial i.e. Day 84 onwards.