CTRI/2025/05/087515 [Registered on: 23/05/2025] Trial Registered Prospectively
Last Modified On:
20/11/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
This is a comparative Phase II/ III study of bevacizumab with ranibizumab in an eye condition called Wet AMD. A total of 202 subjects are planned to be enrolled in this study, the primary outcome is to evaluate the efficacy of RLS bevacizumab in improving vision.
Scientific Title of Study
A prospective, multicentre, randomized, open label, two-arm, parallel group, active control, comparative phase II / phase III clinical study to evaluate efficacy, safety and immunogenicity of R-TPR-023 (RLS-Bevacizumab) / Accentrix® (Ranibizumab) in patients with neovascular (wet) age-related macular degeneration
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RLS/OPT/2024/03, VERSION 2.0, dated 08 Oct 2024
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
Mumbai
MAHARASHTRA
400701
Mumbai MAHARASHTRA 400701 India
Phone
919820804218
Fax
Email
Ajaykumar2.Yadav@relbio.com
Details of Contact Person Scientific Query
Name
Dr Sachin Kagane
Designation
Medical Monitor
Affiliation
Reliance Life Sciences
Address
RLS Clinical Research Group Reliance Life Sciences DALC Rabale Navi Mumbai 400701
Mumbai
MAHARASHTRA
400701
Mumbai MAHARASHTRA 400701 India
Phone
9987885679
Fax
Email
Sachin1.Kagane@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
Mumbai
MAHARASHTRA
400701
Mumbai MAHARASHTRA 400701 India
Phone
919820617721
Fax
Email
Ganesh1.Bagul@relbio.com
Source of Monetary or Material Support
Reliance Life Sciences Pvt Ltd
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
Room No: NA, Department of ophthalmology, division: Dr. R.P. Centre for Ophthalmic Sciences, AIIMS, New Delhi - 110029 New Delhi DELHI
9818598899
Vohrarajpal@gmail.com
Dr Shailendra Birla
Birla Eye Hospital
Room No: 9G8 department of ophthalmology, division: NA, 3rd mahaveer nagar housing board colony, Mahaveer Nagar, Kota 324005 Kota RAJASTHAN
9829230821
drsbirlatrial@gmail.com
Dr Nilesh Giri
D Y Patil Medical College, Hospital & Research Centre
Department of Ophthalmology, Division: NA, Room No : NA, Sant Tukaram Nagar, Pimpri, Pune 411018, Maharashtra, India Pune MAHARASHTRA
7776026323
nilesh.giri@dpu.edu.in
Dr Manoj Khatri
Dr. Agarwals Eye Hospital Ltd
Room No: NA Department of ophthalmology, division: NA, No.222, TTK Road, Alwarpet,
Chennai - 600018, Tamil Nadu, India. Chennai TAMIL NADU
9841439680
drmanojkhatri@gmail.com
Dr Archana Tadwalkar
Dr. D Y Patil Medical College and Research Centre
Room No: NA, Department of Ophthalmology, Division NA, Sector 5, Nerul, Navi Mumbai 400706 Mumbai (Suburban) MAHARASHTRA
9821695176
drarchanat@rediffmail.com
Anjali Sapar
Insight Institute of Opthalmology
Room No 131 to 133, department of Ophthalmology, Division NA
Jay Ganesh Samrajya, H wing, Godawoon Chowk, Spine Road,
Bhosari, Pune – 411039, Maharashtra, India.
Pune MAHARASHTRA
9545680252
dranjalisapar@gmail.com
Dr Sandhya Dharwadkar
KR Hospital
Room No: NA, department of ophthalmology, division NA, Attached to MMC & RI, Irwin Road, Mysore, 570001, Karnatak Mysore KARNATAKA
7204546124
drsandhyahegde@gmail.com
Dr Neha Desai
M & J Western Regional Institute of Ophthalmology
Room no: NA, Department of Opthalmology, Division: NA, Badiya Limbdi Char Rasta, New Civil Hospital CAmpus, Asarwa, Ahmedabad -380016, Gujrat, India Ahmadabad GUJARAT
9909991605
dr.neha_desai@yahoo.com
Dr Parth Rana
Netralaya Super Speciality Eye Hospital
Room No: NA, Department of Ophthalmology, Division NA, 1st Floor KayDee House, Opp. Gujarat Gas, Parimal Garden Cross Road, Ellisbridge, Ahmedabad, Gujarat - 380006 India Ahmadabad GUJARAT
7999999344
Netralaya.rch@gmail.com
Dr Krishnapada Baidya
NRS Medical College and Hospital
Room No: NA, Department of Ophthalmology, Division: NA,138 AJC Bose Road, Kolkata 700014, West Bengal India Kolkata WEST BENGAL
9830292615
drkpbaidya@gmail.com
Dr Fariduddin Khandkar
Regional Institute of Ophthalmology
Room No: NA, Department of Ophthalmology, Division NA, 88 College Street, Kolkata 700073, West Bengal India Kolkata WEST BENGAL
9732982054
k33fariduddin@gmail.com
Dr Punit Kumar Singh
SBKS MI & RC Dhiraj Hospital
Room No : NA, Department of Ophthalmology, Division NA, Sumandeep Vidhyapeeth Deemed to be university, AT & PO Piparia, Ta, Waghodia, Vadodara, Gujrat, India Vadodara GUJARAT
9879946599
punitsinghdr@yahoo.com
Dr Sandeep Parwal
SMS Hospital
Department of Ophthalmology, Charak Bhavan, Room No: OPD BLock,Division Opthalmology, Jaipur 302004, Rajashthan, India Jaipur RAJASTHAN
Institutional Ethics Committee All India Institute of Medical Sciences
Approved
Institutional Ethics Committee, All India Insitute of Medical Sciences Delhi
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
ACCENTRIX
RANIBIZUMAB 2.3 mg in 0.23 ml. The active ingredient is Ranibizumab and dose to be administered is 0.5mg. This was developed by Genentech and marketed by them in USA, and elsewhere by Novartis, under brand name Lucentis. In India, this product is available under brand name Accentrix and manufactured by Novartis.
Intervention
R TPR 023
RLS BEVACIZUMAB 5MG IN 0.2ML. It is Bevacizumab for intravitreal injection, code named R TPR 023 developed by Reliance Life Sciences Pvt Ltd, India. Dose to be administered is 1.25mg. This corresponds to an injection volume of 0.05ml.
Inclusion Criteria
Age From
50.00 Year(s)
Age To
90.00 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, using Early Treatment of Diabetic Retinopathy Study
(ETDRS) charts, of 20/40 to 20/320 (Snellen equivalent) 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. Men and women of childbearing potential must be using adequate birth control
measures, as discussed with the study doctor. Menopausal females must have
experienced their last period more than 12 months prior to study entry to be classified
as not of childbearing potential.
ExclusionCriteria
Details
1. Treatment with verteporfin photodynamic therapy in the study eye within 6 months or
in the non-study eye within 1 week prior to randomization.
2. Previous external-beam radiation therapy, trans-pupillary thermotherapy or subfoveal
focal laser photocoagulation in the study eye.
3. Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1 month
prior to randomization.
4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or
pathologic myopia.
5. History of submacular surgery or other surgical intervention for AMD, previous
intravitreal drug delivery or vitrectomy surgery in the study eye.
6. Current vitreous haemorrhage, subretinal hemorrhage that involves the fovea,
subfoveal fibrosis or atrophy, active intraocular inflammation or infection in the study eye
7. History of retinal pigment epithelial tear, rhegmatogenous retinal detachment or
macular hole (Stage 3 or 4), aphakia or absence of the posterior capsule in the study
eye.
8. Uncontrolled glaucoma (defined as intraocular pressure of 30 mmHg or more despite
treatment with antiglaucoma medications) or history of glaucoma filtering surgery in
the study eye
9. Intraocular surgery (including cataract surgery) within 2 months in the study eye prior
to randomization
10. Any concurrent intraocular condition in the study eye that, in the opinion of the
investigator, could either require medical or surgical intervention during the study
period, or could likely contribute to loss of at least 2 Snellen equivalent lines of best
corrected visual acuity.
11. History of idiopathic or autoimmune-associated uveitis in either eye.
12. Infectious conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye.
13. Patients with controlled or uncontrolled diabetes mellitus.
14. PT and aPTT 1.5 times of ULN
15. Patients who are HIV, HBsAg, HCV test positive.
16. Female patients with positive serum pregnancy test at screening.
17. Prior use of study medication (ranibizumab or bevacizumab); hypersensitivity to
ranibizumab/bevacizumab or any of the excipients in study medication, or history of
allergy to fluorescein.
18. Use of any other anti-VEGF agents within 3 months or 5 half-lives whichever is
longer
19. Participation in any clinical study of an investigational product within previous 3 months
20. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
disease which in the opinion of the investigator will render the patient incapable of
participating in the study.
21. History of other disease, active systemic infection, metabolic dysfunction, physical
examination finding, or clinical laboratory finding giving reasonable suspicion of a
disease or condition that contraindicates the use of an investigational drug or that
might affect interpretation of the results of the study or render the subject at high risk
for treatment complications.
Method of Generating Random Sequence
Other
Method of Concealment
Other
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 16
Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 16
Secondary Outcome
Outcome
TimePoints
Proportion of patients who lost fewer than 15 letters in visual acuity from baseline to week 24
Total Sample Size="202" Sample Size from India="202" 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 2/ Phase 3
Date of First Enrollment (India)
06/06/2025
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="2" Months="5" 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 phase II/ phase III, prospective, multicentre, open label, two-arm, noninferiority, parallel group, active control, randomized, comparative clinical study to evaluate efficacy, safety and immunogenicity of R-TPR-023 (RLS-Bevacizumab)/ Accentrix® (Ranibizumab) in patients with neovascular (wet) age-related macular degeneration. In phase II, total 70 subjects will be enrolled in 1:1 ratio (35 in RLS Bevacizumab group and 35 in Accentrix group). In phase III study, 132 patients with wet AMD will be enrolled in 2:1 ratio (88 in Bevacizumab group and 44 in Accentrix® group)