CTRI/2025/04/084892 [Registered on: 16/04/2025] Trial Registered Prospectively
Last Modified On:
03/09/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Other
Public Title of Study
A study to evaluate effect and safety of Aflibercept with Reference Biologic in
Patients with Neovascular Age-Related Macular degeneration (wet AMD)
Scientific Title of Study
A Prospective, Multicenter, Double-Blind, Active-Controlled, Parallel-Group, Phase III Study
to Compare the Efficacy, Safety and Immunogenicity of Suns Aflibercept with Reference Biologic in
Patients with Neovascular Age-Related Macular degeneration (wet AMD)
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
ICR/24/006 Version 2.0 dated 06/NOV/2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Pravin Ghadge
Designation
Associate Vice President and Head_India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243245598
Fax
Email
pravin.ghadge@sunpharma.com
Details of Contact Person Scientific Query
Name
Dr Dipesh Sonawane
Designation
Deputy General Manager - India Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Dipesh.Sonawane@sunpharma.com
Details of Contact Person Public Query
Name
Chaitali Bornare
Designation
Senior Manager 2 – Medical Affairs & Clinical Research
Affiliation
Sun Pharma Laboratories Limited
Address
Sun House, Plot No. 201, B/1, Western Express Highway, Goregaon (E),
Mumbai, Maharashtra, India
Mumbai (Suburban) MAHARASHTRA 400063 India
Phone
02243244324
Fax
Email
Chaitali.Bornare1@sunpharma.com
Source of Monetary or Material Support
Sun Pharmaceutical Industries Limited
Sun house, Plot No. 201, B/1,
Western Express Highway, Goregaon east. Mumbai (Suburban)
MAHARASHTRA India
Primary Sponsor
Name
Sun Pharmaceutical Industries Limited
Address
Sun house, Plot No. 201, B/1, Western Express Highway, Goregaon east. Mumbai (Suburban) MAHARASHTRA India
Opposite Bullayya College Resapuvanipalem
Visakhapatnam 530013, Andhra Pradesh, India.
Visakhapatnam ANDHRA PRADESH
9440181220
drpremalatharesearch@gmail.com
Dr Rohan Chawla
Dr. Rajendra Prasad Centre for Ophthalmic Sciences,
All India Institute of Medical Sciences, Ansari Nagar New Delhi 110029 South DELHI
9891052939
dr.rohanrpc@gmail.com
Dr Manisha Agarwal
Dr. Shroffs Charity Eye Hospital
5027, Kedarnath Road, Daryaganj, New Delhi 110002
New Delhi DELHI
9811584615
agarwalmannii@yahoo.co.in
Dr Deepika Singhal
GMERS Medical College & Civil Hospital
A Block, 2nd Floor, Room No-204, Department of Ophthalmology, Sola, New Gujarat High Court, S.G. Highway, Ahmedabad, Gujarat, India-380060. Ahmadabad GUJARAT
Room No.106,1 st floor.
M&J Institute of Ophthalmology, Glaucoma Department, Manjushri Mill Compound, Asarwa, Ahmedabad-16, Gujarat India.
Ahmadabad GUJARAT
9825985265
drpurvibhagat@yahoo.com
Dr Jitendra Kumar
M.L.B Medical College
Kanpur Road Jhansi, UP 284128 India
Jhansi UTTAR PRADESH
7007569500
drjitendrakumar1606@gmail.com
Dr Vinod Kumar
Motilal Nehru Medical College,
Department of Opthalmology, OPD No. 11, Ground floor, George Town, Civil Lines, Prayagraj UP 211002. Allahabad UTTAR PRADESH
121/C Chord Road, Rajajinagar, 1st R block Bangalore, 560010, India. Bangalore KARNATAKA
9880643039
drsantoshgk@gmail.com
Dr Aditya Shreekant Kelkar
National Institute of Ophthalmology
1187/30, Off Ghole Road Near Mahatma Phule Museum, Shivajinagar, Pune 411005, Maharashtra, India Pune MAHARASHTRA
9689893887
adityapune4@gmail.com
Dr Parth Rana
Netralaya Super Speciality Eye Hospital
OPD Area room no D1 & R1, 1st Floor, Kay DEE House, Above Union Bank, Parimal Garden Cross Road, Chimanlal Girdharlal Rd, Ambawadi, Ahmedabad, Gujarat 380006 Ahmadabad GUJARAT
7999999344
netralaya.rch@gmail.com
Dr Krishnapada Baidya
Nil Ratan Sircar Medical College & Hospital
Department of Ophthalmology, 138, AJC Bose Road, Kolkata 700014, West Bengal, India. Kolkata WEST BENGAL
9830292615
drkpbaidya@gmail.com
Dr Basavaraj Tigari
Postgraduate Institute of Medical Education and Research
Institutional Human Ethics Committee Psg Institute Of Medical Sciences And Research_Institutional Human Ethics Committee Psg Institute Of Medical Sciences And Research
Supreme Independent Ethics Committee_National Institute of Ophthalmology
Submittted/Under Review
Swarnim Ethics Committee_Netralaya Super Speciality Eye Hospital
Submittted/Under Review
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Aflibercept Injection, 40 mg/mL
Intravitreal injection of Aflibercept
at a dose of 2 mg every 4 weeks for initial 03 injections followed
by one injection every 8 weeks if required
Comparator Agent
Aflibercept Injection, 40 mg/mL (EYLEATM)
Intravitreal injection of Aflibercept at a dose of 2 mg every 4 weeks for initial 03 injections followed by one injection every 8 weeks if require
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
1. Ambulatory patients of either gender aged greater than or equal to 50 years at the time of screening and who are capable of understanding and giving written informed consent.
2. Active primary subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. Active CNV indicates presence of leakage and intra-or sub-retinal fluid detected on FA.
3. Best corrected visual acuity (BCVA), using ETDRS chart, (20/40 to 20/320 Snellen equivalent) in the study eye before pupil dilation screening and randomization
4. Women of childbearing potential must have a negative urine pregnancy test at screening and agree to use highly effective methods of contraception to prevent pregnancy throughout the study and for at least 3 months after last injection
5. Male participants must have had a successful vasectomy (confirmed azoospermia) or must practice highly effective contraception throughout the study period and for at least 3 months after last injection and their female partners must meet the criteria above no. 5.
ExclusionCriteria
Details
Ocular condition in the study eye:
1. Total lesion size greater than 12 DA (30.5 mm2), including blood, scars and neovascularization) as assessed by FA in the study eye.
2. A subretinal haemorrhage involving the centre of the fovea equal to or more than one DA in size or, if the size of the haemorrhage is greater than equal to 50%, of the total lesion area
3. Scar or fibrosis, making up greater than 50% of total lesion or involving the centre of fovea in the study eye.
4. Presence of or history of retinal detachment or retinal pigment epithelial tears or rips involving the macula in the study eye.
5. History of vitreous haemorrhage within 4 weeks prior to screening in the study eye.
6. History of macular hole of stage 2 and above in the study eye.
7. Aphakia or absence of posterior capsule
8. History or presence of corneal dystrophy in the study eye.
9. Significant media opacities, including cataract, in the study eye that might interfere with visual acuity, assessment of safety, or fundus photography.
10. Any concurrent intraocular condition in the study eye that, in the opinion of the Investigator, could require either medical or surgical intervention during the study or may increase the risk of the patient or may interfere with the injection procedure or with evaluation of efficacy or safety.
11. History or clinical evidence of diabetic retinopathy, diabetic macular edema or any other vascular disease affecting the retina, other than AMD, in either eye
12. Presence of active ocular or periocular infection in either eye.
13. Any ocular or periocular infection within the last 3 weeks prior to Screening in either eye.
14. Presence or history of uveitis or scleromalacia in either eye.
15. Uncontrolled glaucoma (defined as IOP greater than equal to 25 mmHg) in the either eye
16. Previous treatment with laser photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT), radiation therapy, intravitreal drug delivery (steroids or device implantation) or any prior ocular treatment for neovascular AMD in the study eye
17. Any prior treatment with anti VEGF therapy in the study eye
8. Any other intraocular surgery (including cataract surgery or Yttrium Aluminium Garnet [YAG] laser posterior capsulotomy in association with prior posterior chamber intraocular lens [IOL] implantation) or periocular surgery within 90 days prior to randomisation in the study eye
19. Prior trabeculectomy or other filtration surgery in the study eye
20. Prior vitrectomy in the study eye.
21. History of any pan retinal photocoagulation in the study eye
22. Any previous systemic treatment for neovascular AMD except dietary supplements or vitamins.
23. Use of any herbal medication for neovascular AMD within 30 days of screening.
24. Current use of medications known to be toxic to the lens, retina, or optic nerve (including but not limited to deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines, vigabatrin, ethambutol, etc.)
25. History of retinal detachment or treatment or surgery for retinal detachment in the study eye.
26. History or presence of any other disease or laboratory findings or clinical evaluation finding that contraindicates the use of an investigational drug or that might affect interpretation of the results of the study or render the patient at high risk for treatment complications
27. Participation in any clinical study within the 3 months prior to screening
28. Known hypersensitivity to Aflibercept or any of the components of study medication
29. Allergy to fluorescein dye
30. Female subjects who are pregnant, breast- feeding, planning to be pregnant during the study; male patients with partner currently pregnant
31. Employee of the Sponsor, Investigator, or study center, with direct involvement in the proposed study as well as family members of the employees of Sponsor or the Investigator.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Sequentially numbered, sealed, opaque envelopes
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Proportion of patients losing fewer than 15 letters (approximately 3 lines) in BCVA
From baseline
(pre dose Day 1) to Week 12.
Secondary Outcome
Outcome
TimePoints
Proportion of patients losing fewer than 15 letters (approximately 3 lines) in BCVA
From baseline
(pre dose Day 1) to Week 24.
Change from baseline in BCVA as measured by ETDRS letter score
from baseline to Week 4, Week
8 Week12, Week 16, Week 20 And Week 24
Proportion of patients who gain at least 15 letters of vision on the ETDRS chart
baseline to
Week 4, Week 8 Week 12, Week 16, Week 20 And Week 24
Change in central retinal thickness in the study eye assessed by OCT
from baseline to Week 24
Change in total NEI VFQ-25 score
from baseline to Week 4, Week 8 Week 12, Week 16, Week 20
and Week 24
Incidence of TEAEs
throughout the study
Proportion of patients with ADA and NAb
at baseline and Week 24
Target Sample Size
Total Sample Size="192" Sample Size from India="192" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
Phase 3
Date of First Enrollment (India)
29/04/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="0" Months="7" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
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 will be a prospective, multicenter, two-arm, double-blind, phase III study. The study will be initiated only after the receipt of regulatory and EC approval.
Screening Period: After obtaining the informed consent, patients will be screened by undergoing various assessments as mentioned in Schedule of Assessment (Appendix I). The duration of screening period will be up to 14 days (2 weeks). After confirming the eligibility patients will be enrolled in the study. Patients will be provided dairy at screening which will be reviewed and retrieved at Visit 2.
Treatment Period: After confirming the eligibility patients will be randomized in Test arm (Sun’s Aflibercept solution for intravitreal Injection, 40 mg/mL) arm or in the Comparator arm (Aflibercept solution for intravitreal Injection, 40 mg/mL, Eylea™) respectively in double blind fashion, by allotting the randomization number.
Post injection, patients will be observed at site for at least 2 hours. Patients will be followed up for efficacy,
safety and immunogenicity, 4 weeks after the end of treatment. Standard of care will be given to the other eye (non-study eye) as per Investigator’s discretion.
In case a patient is discontinued early, patient should be followed up for efficacy, safety 4 weeks after last treatment dose. Patients will be dispensed a visit diary at each visit from randomization to end of treatment to record concomitant medication, any adverse event. Patient will be advised to bring completed diary to the site at each visit.