CTRI/2025/10/095593 [Registered on: 03/10/2025] Trial Registered Prospectively
Last Modified On:
20/05/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group Trial
Public Title of Study
This is a comparative phase III clinical trial in an eye condition called WET AMD. A study of an eye injection Aflibercept for improving vision and assessing safety in patients. Total 382 subjects will be enrolled in the study. The main outcome is to demonstrate the efficacy of RLS-aflibercept
Scientific Title of Study
A Prospective, Multicenter, Randomized, Double-Blind, Parallel-Group, Two-Arm Comparative Clinical Study to evaluate the Efficacy, Safety, Pharmacokinetics and
Immunogenicity of R-TPR-051 (RLS-Aflibercept) and Eylea® administered by intravitreal injection in Patients with
Neovascular (Wet) Age-Related Macular Degeneration (AMD)
Trial Acronym
NA
Secondary IDs if Any
Secondary ID
Identifier
RLS/OPT/2024/04, Version 3.0 dated 23 Apr 2025
DCGI
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Ajay Kumar Yadav
Designation
AVP & Head Clinical Research Group
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 MAHARASHTRA
RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 MAHARASHTRA
Mumbai MAHARASHTRA 400701 India
Phone
9272906116
Fax
Email
Abhijeet10.Patil@relbio.com
Details of Contact Person Public Query
Name
Mr Ganesh Bagul
Designation
Head Clinical Operations
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701 MAHARASHTRA
Mumbai MAHARASHTRA 400701 India
Phone
9820617721
Fax
Email
Ganesh1.Bagul@relbio.com
Source of Monetary or Material Support
NIL
Primary Sponsor
Name
Reliance Life Sciences Pvt. Ltd
Address
Reliance Life Sciences Pvt. Ltd.,Dhirubhai Ambani Life Sciences Centre,Plot no. R-282, TTC area of MIDC, Thane Belapur Road, Rabale, Navi Mumbai – 400710, Maharashtra, India
K R Hospital attached to Mysore Medical College & Research lnstitute
Department of Ophthalmology,
K R Hospital attached to Mysore Medical College & Research lnstitute, lrwin Road, Mysore 570001, Karnataka, lndia.
Mysore KARNATAKA
7204546124
drsandhyahegde@gmail.com
Dr Sucheta Parija
AIIMS Bhubaneshwar
Room No NA, Division of Ophthalmology, Department of Ophthalmology, AIIMS, Bhubaneshwar, Odisha Khordha ORISSA
9437044380
suchetaparija@yahoo.com
Dr Vijaya Sahu
All India Institute of Medical Sciences
Room No: NA, Department of Ophthalmology, Division NA, G.E. Road, Tatibandh,
Raipur-492099, Chhattisgarh, India. Raipur CHHATTISGARH
9752679556
drvijayasahu77@gmail.com
Dr Vandana Iyer
All India Institute of Medical Sciences,
Room No: NA, Department of Ophthalmology, Division NA, Plot no-2, Sector 20,
MIHAN, Nagpur- 441108, Maharashtra, India. Nagpur MAHARASHTRA
9962253382
dr.vai@outlook.com
Dr Rajpal Vohra
All India Institute of Medical Sciences, New Delhi
Room No. NA, Department of Ophthalmology, division of Dr. RP Centre of Ophthalmic Sciences, AIIMS, New Delhi - 110029, Delhi, India New Delhi DELHI
9818598899
Vohrarajpal@gmail.com
Dr Sandip Patil
Belgavi Institute of Medical Sciences
Room No: Na, Division Na, Department of Ophthalmology, Belgavi Institute of Medical Sciences, Belgavi Dr B R Ambedkar Road, Belgavi- 590001, Karnataka, India Belgaum KARNATAKA
9945447572
drsandeepatil@gmail.com
Dr Pooja Bansal
Centre for Sight
Room No NA, Department of Ophthalmology, Division NA, B-5/24, Safdarjung Enclave, Opp Dear Park, New Delhi-110029 New Delhi DELHI
9953750860
drpoojabansal13@gmail.com
Dr Sukant Pandey
Dr. Jawahar Lal Rohatgi Smarak Netr
Room No: NA, Department of Ophthalmology, Division NA, Dr. Jawahar Lal Rohatgi Srnarak Netra, Chikitsalaya, 117/52 ,Sarvodaya Nagar, Kanpur- 208005, Uttar Pradesh, lndia Kanpur Nagar UTTAR PRADESH
9005189529
sukantpandey@hotmail.com
Dr Jagdish Loya
Drushti Eye Institute Pvt Ltd
Room No NA, Department of Ophthalmology, Division NA, 117, Samarthnagar, Varad Ganesh mandir Road, Chh Sambhajinagar, maharashtra - India 431001 Aurangabad MAHARASHTRA
9422217355
drjagdish.loya@gmail.com
Dr Deepika Singhal
GMERS Medical College and Civil Hospital
Room No: NA, Department of Ophthalmology, Division NA, GMERS Medical College and Civil Hospital Sola, Department of Ophthalmology, Nr. Gujarat High Court, S. G. Highway, Sola Ahmedabad, 380060, Gujarat, India
Ahmadabad GUJARAT
9426541167
deepika1103@yahoo.com
Dr Abhishek Anand
Indira Gandhi Institute of Medical Science
Room No NA, Department of Ophthalmology, Division NA, Regional Institute Of Ophthalmology, IGIMS, Sheikhpura Raja Bazar Patna, Bihar 800014 Patna BIHAR
8294777993
eyehospitalpatna@gmail.com
Dr Anjali Sapar
Insight Institute of Ophthalmology
Room No: NA, Department of Opthalmology, Division NA, Insight Institute of Ophthalmology and Laser Center, Godawoon chowk, Spine road, Bhosari, Pune-411039, Maharashtra, India
Pune MAHARASHTRA
9545680252
dranjalisapar@gmail.com
Dr Ashish Sharma
Lotus Eye Hospital
Room No: NA, Department of Ophtalmology, Division NA, Lotus Eye Hospital and lnstitute Limited, 770/12, Avinashi Road, Civil Aerodrome Post, Coimbatore-641014 Tamil nadu, lndia
Coimbatore TAMIL NADU
8144973937
drashish79@hotmail.com
Dr Neha Desai
M & J Western Regional Institute of Ophthalmology
Room No: NA, Department of Ophthalmology, Division NA, M & J Western Regional Institute of Ophthalmology, A Unit of
B.J Medical College, Badiya Limbdi Char Rasta, New Civil
Hospital Campus, Asarwa, Ahmedabad-380016, Gujarat, India Ahmadabad GUJARAT
9909991605
dr.neha_desai@yahoo.com
Dr Shashidhar S
Minto Ophthalmic Hospital,
Room No: NA, Department of NA, Division NA, Minto Ophthalmic Hospital, BMC & RI, Chamrajpet, Tippu Sultan Palace Road, opposite V. V. Puram Police Station, New Tharagupet, Bangalore-560002, Karnataka, India
Bangalore KARNATAKA
9845779330
swamyshashidhar@gmail.com
Dr Rohit Laul
Modern Eye Hospital
Room No: NA, Department of Ophthalmology, Division NA, Modern Eye Hospital, 11-13-G, Suyojit Modern Point, Opposite Police Parade Ground, Sharanpur Road, Nashik-422002, Maharashtra, India
Nashik MAHARASHTRA
9656442160
drlaulrs@gmail.com
Dr Anup Shah
Navkar Eye Clinic
Room No NA, Department of Ophthalmology, Division NA, Rushabh Residency, opp Telephone Exchange, Hotel Front Page Lane, Canada Corner, Nashik 422002, Maharashtra, India Nashik MAHARASHTRA
9850501495
dranupshah@gmail.com
Dr Parth Rana
Netralaya Super Speciality Hospital
Room No: NA, Department of Ophthalmology, Division NA, Netralaya Super Speciality Hospital, 1st Floor, K D House,
Above Union Bank of India, Oppo Gujarat Gas, Piramal Garden
Cross Road, CG Road, Ahmedabad-380006, Gujarat, India. Ahmadabad GUJARAT
7999999344
netralaya.rch@gmail.com
Dr Shreyangsi Biswas
Nil Ratan Sircar Medical College & Hospital
Room No NA, Department of ophthalmology Division NA, 138 AJC Bose Road, Kolkata, India Kolkata WEST BENGAL
9830692465
bshreyangsi.93@gmail.com
Dr L K Mondal
Regional Institute of Ophthalmology
Regional Institute of Ophthalmology, Room No: NA, Department of Ophthalmology, Division NA,88 College Street, Kolkata-700073, West Bengal, India. Kolkata WEST BENGAL
9830830216
Lakshmi.mondal62@gmail.com
Dr Alok Sen
Sadguru Netra Chikitsalaya
Room No: NA, Department of Ophthalmology, Division NA, Sadguru Netra Chikitsalaya, Shri Sadguru Seva Sangh Trust, Jankikund, District Satna, Chitrakoot-210204, Madhya pradesh, India
Satna MADHYA PRADESH
7898201605
draloksen@gmail.com
Dr Minija CK
Sankara Eye Hospital
Room No: NA, Department of ophthalmology, Division NA, Sankara Eye Hospital, Varthur Main Road, Kundanahalli Gate, Bangalore-560037, Karnataka, India
Bangalore KARNATAKA
9480587018
minija_ck@yahoo.co.in
Dr Prabhu Shanker
Sankara Eye Hospital
Room No: NA, Department of Ophthalmology, Division NA, Sankara Eye Hospital, Sathy Road, Sivanandpuram, Coimbatore-641035, Tamilnadu, India.
Coimbatore TAMIL NADU
Magna-Care Ethics Committee, Chopda Medicare & Research Centre
Approved
Swarnim Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H318||Other specified disorders of choroid,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Eylea
Route: Intravitreal injection,
Dose: Subjects will be randomised in a 1:1 ratio to receive either R-TPR-051 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 doses (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in Eylea® treatment group (except those who have consented for PK assessment) will be randomised again in a 1:1 ratio to either continue on Eylea® treatment or be transitioned to R-TPR-051 treatment. In the 8-week treatment cycle, IPs (R-TPR-051 or Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 52, corresponding to the end of follow-up for all subjects.
Intervention
R-TPR-051(RLS-Aflibercept)
Route: Intravitreal injection,
Dose: Subjects will be randomised in a 1:1 ratio to receive either R-TPR-051 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4 weeks for the first 3 doses (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every 8 weeks). At Week 32, subjects in Eylea® treatment group (except those who have consented for PK assessment) will be randomised again in a 1:1 ratio to either continue on Eylea® treatment or be transitioned to R-TPR-051 treatment. In the 8-week treatment cycle, IPs (R-TPR-051 or Eylea®) will be administered up to Week 48, and the last assessment will be done at Week 52, corresponding to the end of follow-up for all subjects.
Inclusion Criteria
Age From
50.00 Year(s)
Age To
99.99 Year(s)
Gender
Both
Details
1. Male or female patients of age more than or equal to 50 years
2. Active primary or recurrent subfoveal lesions with classic or occult choroidal
neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the
study eye
3. Best corrected visual acuity (BCVA) of 20/40 to 20/200 (letter score of 73 to 34,
inclusive) using original series Early Treatment Diabetic Retinopathy Study (ETDRS)
charts in the study eye at screening and at week 0 (day 1) prior to randomization in the
study eye
4. Able to understand the study procedures and the risks involved, willing to provide
written Informed Consent, and able to adhere to study schedules and requirements
5. Non-childbearing potential female (e.g., permanently sterilized, postmenopausal
[defined as 12 months with no menses without an alternative medical cause prior to
Screening]), OR childbearing potential female subjects or male subjects with their
(respectively male or female) partners who agree to use at least two forms of appropriate
contraception method that can achieve a failure rate of less than 1% per year (e.g.,
established use of oral, injected, intravaginal, transdermal, or implanted hormonal
contraceptive, placement of an intrauterine device or intrauterine hormone-releasing
system, bilateral tubal occlusion, vasectomised partner, physical barrier, sexual
abstinence) from Screening until 3 months after the last IVT injection of IP
ExclusionCriteria
Details
1. Known history of hypersensitivity or allergic reactions to aflibercept or any of its excipients.
2. Study eye: Sub- or intra-retinal haemorrhage that comprises more than 50% of the entire lesion or presence of blood with the size of 1 DA or more involving the centre of fovea (confirmed by the central reading center during screening)
3. Study eye: Scar, fibrosis, or atrophy involving the centre of the fovea (confirmed by
the central reading center during screening)
4. Study eye: Presence of CNV due to other causes, such as ocular histoplasmosis,
trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture, or
pathologic myopia (confirmed by the central reading center during screening)
5. Study eye: Presence of retinal pigment epithelial tears or rips involving the macula
(confirmed by the central reading center during screening)
6. Study eye: Presence of macular hole at any stage (confirmed by the central reading
center during screening)
7. Study eye: Any concurrent macular abnormality other than AMD which could affect
central vision or the efficacy of IP including but not limited to epiretinal membrane,
vitreomacular traction, macular telangiectasia, retinal vascular abnormality, etc.
(confirmed by the central reading center during screening)
8. Study eye: Any concurrent ocular condition which, in the opinion of the Investigator,
could either confound the interpretation of efficacy and safety of IP (e.g., ocular
media opacities such as significant cataract, optic neuropathy etc.) or require medical
or surgical intervention during the study period
9. Either eye: History or clinical evidence of diabetic retinopathy (except for mild nonproliferative diabetic retinopathy) or diabetic macular oedema (DME)
10. Study eye: Current vitreous haemorrhage
11. Either eye: Any previous IVT anti-vascular endothelial growth factor (VEGF)
treatment (e.g., bevacizumab, ranibizumab, aflibercept, pegaptanib, etc.)
12. Any previous systemic anti-VEGF treatment
13. Study eye: History of treatment involving macula such as macular laser
photocoagulation, photodynamic therapy (PDT), transpupillary thermotherapy (TTT),
radiation therapy, or any ocular treatment for neovascular AMD
14. Any systemic treatment or therapy (including prescribed herbal medication) to treat
neovascular AMD within 30 days prior to randomisation, and such treatment or
therapy will not be allowed during the study period. However, dietary supplements, vitamins, or minerals will be allowed.
15. Study eye: History of vitrectomy, scleral bucking (encircling), glaucoma filtration
surgery, corneal transplantation, or pan-retinal photocoagulation
16. Study eye: Previous ocular (intraocular and peribulbar) corticosteroids
injection/implant within 1 year prior to randomisation
17. Study eye: Topical ocular corticosteroids administered for less than 30 consecutive days or for more than 60 non-consecutive days within 90 days prior to randomisation.
18. Use of systemic corticosteroids for 30 or more consecutive days within 90 days prior
to randomisation (inhaled steroid is permitted)
19. Study eye: 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, except for lid surgery, which may not have taken place within 30 days prior to randomisation
20. Current use of medications known to be toxic to the lens, retina, or optic nerve,
including deferoxamine, chloroquine/hydroxychloroquine, tamoxifen, phenothiazines,
vigabatrin, ethambutol at Screening and such medications will not be allowed during
the study period
21. Study eye: Previous radiation therapy near the region of the study eye.
22. Previous participation in clinical studies with IP to treat neovascular AMD in either
eye
23. Previous participation in clinical studies with IP to treat disease other than neovascular AMD within 90 days prior to randomisation (excluding dietary supplementary,
vitamins, and minerals). Such participation will not be allowed during the study period even if the IP is dietary supplementary, vitamins, or minerals.
24. Subject with only one functional eye (defined as BCVA of counting finger or less on
the eye with worse vision)
25. Study eye: Spherical equivalent of the refractive error demonstrating more than 6
diopters of myopia. For subjects who have undergone previous refractive or cataract
surgery in the study eye, the preoperative refractive error in the study eye cannot
exceed 6 diopters of myopia.
26. Study eye: Aphakia or absence of the posterior capsule (unless it occurred as a result of
a YAG laser posterior capsulotomy in association with prior posterior chamber IOL
implantation)
27. Either eye: Active or suspected ocular and periocular infection at Screening or at
randomisation (e.g., infectious blepharitis, infectious conjunctivitis, infection in
eyelid)
28 Either eye - Active intraocular inflammation including scleritis at Screening or at
randomisation
29. Either eye- History of idiopathic or autoimmune-associated uveitis
30. Study eye: Uncontrolled ocular hypertension (defined as intraocular pressure [IOP] more than
25 mmHg despite treatment with anti-glaucoma medication) at Screening
31. Known allergic reactions and/or hypersensitivity to any component of Eylea® or RTPR-051
32. History of allergy to the fluorescein sodium for injection in angiography
33. History of a medical condition that would preclude scheduled study visits or safe use
of IP in the opinion of the Investigator (e.g., history of organ transplant, immunocompromised subject, etc.)
34. Uncontrolled systemic disease including but not limited to uncontrolled diabetes
mellitus (in the opinion of the Investigator), uncontrolled systemic hypertension
(systolic blood pressure more than 180 mmHg and/or diastolic blood pressure more than 100 mmHg on
optimal medical regimen), or uncontrolled atrial fibrillation (resting heart rate more than 110
beats per minutes) at Screening.
35. Stroke, transient ischaemic attacks, or myocardial infarction within 180 days prior to
randomisation
36. History of recurrent significant infections and, or current treatment for systemic
infection
37. Severe renal impairment with dialysis or a history of renal transplant
38. Malignancy (other than non-melanoma skin cancer) under treatment or with history of
metastatic disease.
39. Women of childbearing potential who are pregnant, planning to become pregnant,
lactating, or not using adequate birth control, as specified in protocol. For women of
childbearing potential, a serum pregnancy test must result negative at Screening.
40. Positive HIV, HBsAg or HCV test at screening
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
The primary objective of this study is to demonstrate the equivalence in efficacy of
R-TPR-051 compared to Eylea® in subjects with neovascular age-related macular
degeneration (AMD)
Change from baseline in Best Corrected Visual Acuity (BCVA) at Week 8
Secondary Outcome
Outcome
TimePoints
To evaluate the immunogenicity of R-TPR-051 compared to Eylea: 1. Incidence of anti-drug antibodies (ADAs) to aflibercept
2. Incidence of neutralising antibodies (NAbs) to aflibercept
Secondary Outcomes :
1. Change from baseline in BCVA over time
2. Proportion of subjects who lost fewer than 15 letters in BCVA
3. Proportion of subjects who gained 15 letters or more in BCVA
4. Change from baseline in central subfield thickness (CST)
5. Proportion of subjects with intra- or sub-retinal fluid on optical coherence tomography
6. Change from baseline in CNV area
7. Proportion of subjects with active CNV leakage
Baseline to Week 32 and Week 52
Safety Evaluation:
1. Incidence of ocular adverse events (AEs) or serious ocular AEs
2. Incidence of non-ocular AEs and serious non-ocular AEs
3. Incidence of intraocular inflammation and IOP increase
4. Changes in vital signs and clinical laboratory parameters
baseline to end of study (week 52)
Target Sample Size
Total Sample Size="382" Sample Size from India="382" 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)
17/03/2026
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="4" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Open to Recruitment
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 is a prospective, multicenter, double-blind, two-arm, parallel group, active control,
randomized, comparative phase III clinical trial.
After obtaining written informed consent, subjects will be screened to determine their
eligibility forstudy participation. Subjects will be randomised in a 1:1 ratio to receive either RTPR-051 or Eylea® (administered via intravitreal [IVT] injection 2 mg [0.05 mL] every 4
weeks for the first 3 doses (i.e., at Weeks 0, 4, and 8), followed by 2 mg [0.05 mL] once every
8 weeks). At Week 32, subjects in Eylea® treatment group (except those who have consented
for PK assessment) will be randomised again in a 1:1 ratio to either continue on Eylea®
treatment or be transitioned to R-TPR-051 treatment. In the 8-week treatment cycle, IPs (RTPR-051 or Eylea®) will be administered up to Week 48, and the last assessment will be done
at Week 52, corresponding to the end of follow-up for all subjects. A total of 382 patients with
neovascular AMD will be enrolled