CTRI/2025/08/093929 [Registered on: 29/08/2025] Trial Registered Prospectively
Last Modified On:
26/03/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group Trial
Public Title of Study
This is a study to Evaluate the Efficacy, Safety, Pharmacokinetics and
Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with
Neovascular (wet) Age-Related Macular Degeneration
Scientific Title of Study
A Phase 2/3, Randomized, Double-Masked, Parallel Group,
Multicentre, Comparative Clinical Study to Evaluate the Efficacy, Safety,
Pharmacokinetics and Immunogenicity of Intas Bevacizumab and
Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age-
Related Macular Degeneration
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
Protocol No: 0235-24, Version No: 3.0, Dated: 02-Apr-2025
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Naman Shah
Designation
Associate Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India, 382481.
Ahmadabad GUJARAT 382481 India
Phone
07940202389
Fax
07940202021
Email
namanshah@lambda-cro.com
Details of Contact Person Scientific Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India, 382481.
Ahmadabad GUJARAT 382481 India
Phone
07940202288
Fax
07940202021
Email
jogeshmahajan@lambda-cro.com
Details of Contact Person Public Query
Name
Dr Jogesh Mahajan
Designation
Senior Vice President
Affiliation
Lambda Therapeutic Research Ltd
Address
Lambda House, Plot No. 38, Survey no. 388, Near Silver Oak Club, S.G. Highway, Gota, Ahmadabad, Gujarat, India, 382481.
Department of Clinical research, Room No. NA, Rajiv Gandhi Salai (OMR), Kelambakkam, Tamil Nadu, India
Kancheepuram TAMIL NADU
9497154284
drpremnath20@gmail.com
Dr Nilesh Giri
D Y Patil Medical College, Hospital & Research Centre
Sant Tukaram Nagar, Pimpri, Pune, Maharashtra 411018.
Pune MAHARASHTRA
9284528896
nilesh.giri@dpu.edu.in
Dr Punit Kumar Singh
Dhiraj Hospital, SBKS MI & RC
Department of Clinical research, Room No. NA, Dhiraj Hospital, SBKS MI & RC Sumandeep Vidyapeeth Deemed to be University, At & Po. Piparia, Taluka, Waghodia, Vadodara 391760, Gujarat, India
Vadodara GUJARAT
9879946599
punitsinghdr@yahoo.com
Dr Debdulal Chakraborty
Disha Eye Hospital Pvt Ltd.
Department of Clinical research, Room No. NA, Disha Eye Hospital Pvt Ltd. 14 Grand Trunk Road Sheoraphuli West Bengal 712223
Hugli WEST BENGAL
8777894554
devdc@rediffmail.com
Dr Manoj Khatri
Dr. Agarwals Eye Hospital
Department of Clinical research, Room No. NA, Dr. Agarwals Eye hospital #222 TTK Road, Alwarpet, Chennai-600018 Chennai TAMIL NADU
9841439680
drmanojkhatri@gmail.com
Dr Atul Sahu
Dr. Agarwals Healthcare Limited
Department of Clinical research, Room No. NA, D 63 / 10 B-1A, Dayal Enclave, Mahmoorganj, Varanasi - 221010, Uttrarpradesh, India
Varanasi UTTAR PRADESH
8808069485
dratulkrsahu@gmail.com
Dr Vinod Kumar
Dr. Rajendra Prasad Center for ophthalmic Science AIIMS
Department of Clinical research, Room No. NA, Dr. Rajendra Prasad Center for ophthalmic Science AIIMS Campus Temple, Sri Aurbindo Marg, Ansari Nagar East, New Delhi-110029 India.
New Delhi DELHI
9868420620
drvinod_agg@yahoo.com
Dr Anita Gaikwad
H. V Desai EYE Hospital
"93, Tarawade Vasti, Mohammadwadi
Hadapsar, Pune-411060"
Pune MAHARASHTRA
02026974117
dr.gaikwad.anita@gmail.com
Dr Bhavik Zala
Jyoti Eye Hospital
Department of Clinical research, Room No. NA, 305-307, 3rd floor, Arjun Icconic, B/h. Ranna Park bus stand, Opp. Satya-2 Complex, Naranpura, Ahmedabad - 380013,
Ahmadabad GUJARAT
Department of Clinical research, Room No. NA, Purulia Road, Ranchi, Jharkhand 834001
Ranchi JHARKHAND
9811826765
drbibhutikashyap@gmail.com
Dr Ashish Sharma
Lotus Eye Hospital & Institute
Department of Clinical research, Room No. NA, Avinashi Road, Near Passpoft Office, Peelamedu. Civil Aerodrome Post, Coimbatore - 641014, Tamil Nadu, India
Coimbatore TAMIL NADU
8144973937
drashish79@hotmail.com
Dr Chaitra Jaydev
Narayana Nethralaya
Department of Clinical research, Room No. NA, 121/C, Chord Road,1st R Block Rajajinagar, Bangalore, Karnataka-560010, India
Bangalore KARNATAKA
9740021362
drchaitra@hotmail.com
Dr Sri Bhargava Natesh
Nethra Eye Hospital
Department of Clinical research, Room No. NA,, No. 8, Poojary Layout, 80 Ft. Road, Sanjaynagar, Bengaluru, Karnataka 560094
Bangalore KARNATAKA
9342880773
sribhargava.natesh@gmail.com
Dr Rana Parth Jagdish Kumar
Netralaya Super Speciality Eye Hospital
Department of Clinical research, Room No. NA, 1st Floor K D House,Above Union Bnak , Opp. Gujarat Gas,Parimal Garden Cross Road, Ahmedabad,380006,Gujarat,India
Ahmadabad GUJARAT
7557777755
netralaya.rch@gmail.com
Dr Mudit Bansal
Netralok Retina Clinic
Department of Clinical research, Room No. NA, Netralok Retina Clinic, 304-305 Golden Icon, Above Hyundai Showroom, Opp Medlink Hospital, Nr Shyamal Cross Road, 132 ft. Ring Road, Satellite, Ahmedabad -15 Gujrat India
Ahmadabad GUJARAT
Department of Clinical research, Room No. NA, 4 L. K. Society, B/H Sunset Row House, Next to Sterling Hospital, Gurukul Road, Memnagar, Ahmedabad-380052
Ahmadabad GUJARAT
9904738885
urmilmshah2010@gmail.com
Dr Vishali Gupta
Post graduate institute of medical education & research
Department of Clinical research, Room No. NA, Advanced Eye Centre, PGIMER, Sector 12, Chandigarh 160012, Punjab, India
Chandigarh CHANDIGARH
9417565506
vishalisara@gmail.com
Dr Vasumathy
Radhatri Nethralaya
Department of Clinical research, Room No. NA, 12, Hindi Prachara Sabha Street, T.Nagar,Chennai - 600070
Chennai TAMIL NADU
Department of Clinical research, Room No. NA,Varthur Main Road, Kundalahalli Gate, Bangalore 560037
Bangalore KARNATAKA
9448881500
nidhidubey@sankaraeye.com
Dr Dhanashree Ratra
Sankara Nethralaya Medical Research Foundation
Department of Clinical research, Room No. NA, Sankara Nethralaya Medical Research Foundation, Padmabhushan Dr. S S Badrinath Campus 18/41, College Road, Nungambakkam, Chennai - 600006, Tamilnadu India
Chennai TAMIL NADU
9940084285
drdad@snmail.org
Dr Sharad Bhomaj
Shanti Saroj Netralay
Department of Clinical research, Room No. NA, A N Gaikwad 901/902, Beside Sundar Nagar, Anand Nursing Home road, off sangli-Miraj Road, Miraj, Maharashtra 416410.
Sangli MAHARASHTRA
9960516364
Sharadbhomaj@gmail.com
Dr Shobhana Mange
Shivam Retina Clinic and eye Hospital
Department of Clinical
research, Room No.
NA, HG-1 A, ITC Building, Majura Gate, Ring Road, Surat- 395001 Gujarat, India
Surat GUJARAT
9979530073
drshobhnamange@gmail.com
Dr Rushikesh Naigoankar
Shri Ganpati Netralaya
Department of Clinical research, Room No. NA, Shri Ganpati Netralaya, Devalgoanraja-Mantha Road, Jalna, Maharashtra, - 431203, India
Jalna MAHARASHTRA
9620842069
md@netralaya.org
Dr Aditya Sudhalkar
Sterling Hospitals
Department of Clinical research, Room No. NA, Race Course road, Opp. INOX Cinema, Harinagar Circle (West), Vadodara-390007
Vadodara GUJARAT
9909917561
adityasudhalkar@yahoo.com
Dr Swapnil Vidhate
Subhadra Netralaya and Sharda Neurocare
4th floor, Shreeji Bizz World Kathegalli Signal Nashik-pune Highway, opp. Camel House,Dwarka,Nashik, Maharashtra, 422011 Nashik MAHARASHTRA
Disha Eye Hospital Pvt Ltd Ethics Committee, Dr. Debdulal Chakraborty
Approved
Dr. Agarwals Eye Hospital IEC, Dr. Manoj Khatri
Submittted/Under Review
Ethics Committee Institutional Review Board, Dr. Nidhi Dubey
Submittted/Under Review
Ethics Committee of Navneet Memorial Hospital, Dr. Mudit Bansal
Approved
Ethics Committee,Dr.D.Y.Patil Vidyapeeth, Dr. Nilesh Giri
Submittted/Under Review
IEC, Shaishwari Clinic - Hospital for Mental Heralth, Dr. Sharad Bhomaj
Approved
Institute Ethics Committee, All India institute of medical Sciences, Dr. Vinod Kumar
Approved
Institute Ethics Committee, SV Sumandeep Vidyapeeth, Dr. Punit Kumar Singh
Approved
Institutional Ethics Committee PBMAs H V Desai Eye Hospital, Dr. Anita Gaikwad
Submittted/Under Review
Institutional Ethics Committee(IEC)-Kailash Cancer ho, Dr. Aditya Sudhalkarspital and research Centre, Dr. Aditya Sudhalkar
Approved
Institutional Ethics Committee, Ashwin Hospital, Dr. Ashish Sharma
Approved
Institutional Review Board Ethics Committee, Dr Dhanashree Ratra
Approved
Kar Vision Institutional Ethics Committee, Dr. Sanghamitra Kanungo
Approved
Kashyap Memorial Eye hospital Ethics Committee, Dr. Bibhuti Kashyap
Approved
lnstitutional Ethics Committee, Post Graduate lnstitute of Medical Education and Research, Dr. Vishali Gupta
Submittted/Under Review
Narayana Nethralaya Ethics Committee, Dr. Chaitra Jaydev
Approved
PRANAV DIABETES CENTER ETHICS COMMITTE, Dr. Sri Bhargava Natesh
Approved
Radhatri Nethralaya, Institutional Ethics Committee, Dr. Vasumathy
Approved
Riddhi Medical Nursing Home IEC, Dr. Ruchi Mehta
Approved
Sangini Hospital Ethics Committee, Dr. Bhavik Zala
Submittted/Under Review
Shree Institutional Ethics Committeemittee, Dr. Swapnil Vidhate
Submittted/Under Review
Shri Ganpati Netralaya Ethics Committee, Dr. Rushikesh Naigoankar
Approved
Somani Hospital Ethics Committee, Dr. Vishal Agrawal
Submittted/Under Review
Swarnim Ethics Committee, Dr. Rana Parth Jagdish Kumar
Approved
The Institutional Ethics Committee, Shri Sadguru seva Sangh Trust, Dr. Alok Sen
Approved
Unity Hospital Ethics Committee, Dr. Shobhana Mange
Approved
YAKSHIT INDEPENDENT ETHICS COMMITTEE, Dr. Abhishek Dixit
Approved
Yakshit Independent Ethics, Dr. Atul Sahuittee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: H00-H59||Diseases of the eye and adnexa,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Bevacizumab arm (T)
Dose: Single-use vial, Unit Dose Strength: Each single-use vial contains 5.75 mg of
bevacizumab in 0.23 mL solution, Dosage Level: 1.25 mg (0.05 mL of 25 mg/mL)
intravitreal injection once every 4 weeks, Route of Administration: Intravitreal injection
Comparator Agent
Ranibizumab arm (R)
Dose: Single-use vial, Unit Dose Strength: Each single-use vial contains 2.3 mg of
Ranibizumab in 0.23 mL solution. This
provides a suitable amount to deliver a
single dose of 0.05 ml containing 0.5 mg
Ranibizumab, Dosage Level: 0.5 mg (0.05 mL of 10 mg/mL) intravitreal injection once every 4 weeks, Route of Administration: Intravitreal injection
Inclusion Criteria
Age From
50.00 Year(s)
Age To
90.00 Year(s)
Gender
Both
Details
1) Must sign an ICF indicating that the participant understands the purpose of, and procedures
required for the study as described in section 10.1.3 and in this protocol and is willing to abide
by the requirements during participation in the study.
2) Male or and female (assigned at birth, inclusive of all gender identities)
3) Age of greater than or equal to 50 (completed years) at the time of signing the informed consent.
4) Primary or recurrent, Anti-VEGF naïve participants with active choroid neovascularization
(CNV) lesion involving the central subfield secondary to neovascular (wet) age-related macular
degeneration (AMD) in the study eye at Screening as assessed by the investigator. Note 1: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and or intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT). Note 2: All subtypes of nAMD CNV lesions are permissible (i.e., classic CNV, occult CNV, or with some classic CNV component, or retinal angiomatous proliferation lesions with a CNV
component). Note 3: If both eyes are affected and eligible, the investigator should consider the worst eye in preference to the other, if the fellow eye can await treatment with anti-VEGF for the duration of study participation.
5) BCVA of less than or equal to 73 and greater than or equal to 24 ETDRS letter score (Approximate 20 per 40 and 20 per 320 Snellens
equivalent) using Early Treatment Diabetic Retinopathy Study chart (ETDRS) testing at a
distance of 4 meters in the study eye at Screening and Baseline.
6) Study eye with sufficiently clear ocular media and adequate pupillary dilation that allows for
adequate visualization of the fundus with indirect ophthalmoscopy and to permit adequate quality
ocular imaging.
7) A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies: Is not a woman of childbearing potential (WOCBP) OR Is a WOCBP and using a contraceptive method that is highly effective (with a failure rate of
less than 1 precent per year), with low user dependency when used consistently and correctly, as described in section 10.4 during the intervention period and for at least 3 months after the last dose of study intervention. The investigator should evaluate the effectiveness of the contraceptive method in relationship to the first dose of study intervention. WOCBP agrees not to donate eggs (ova, oocytes), freeze them for future use for reproduction or retrieve them for their own use during the recommended period of contraception. A WOCBP must have a negative highly sensitive serum B-human chorionic gonadotropin
(BhCG) test at Screening and urine BhCG test at Baseline. If a urine test cannot be confirmed as negative (e.g., an ambiguous result), a serum pregnancy test is required. In such cases, the participant must be excluded from participation if the serum pregnancy result is positive. The investigator is responsible for review of medical history, menstrual history, and recent
sexual activity to decrease the risk for inclusion of a woman with an early undetected pregnant
8) Male participants are eligible to participate if they agree to the following during the intervention period and for at least 03 months after the last dose of the study intervention. Must agree not to plan to father a child or donate sperm for reproduction; PLUS, Either of the following: Be abstinent from heterosexual [or homosexual] intercourse as their preferred and usual lifestyle (abstinent on a long-term and persistent basis) and agree to remain abstinent; OR Must agree to use contraception barrier as detailed below: A male participant must wear a condom when engaging in any activity so that condom prevents passage of ejaculate to another person. Male participants should also be advised of the benefit for a female partner to use a highly effective method of contraception as the condom may break or leak when having sexual intercourse with a woman of childbearing potential who is not currently pregnant.
ExclusionCriteria
Details
1) Poor quality of SD-OCT and fundus angiography images at Screening Baseline.
2) Presence of fibrosis, atrophy or scarring involving fovea in the study eye at Screening as assessed qualitatively by the investigator from CFP FA images.
3) Subretinal haemorrhage in the central subfield of the study eye which either (a) involves fovea; or (b) has a total area of greater than or equal to 50 percent of the total lesion area at Screening as assessed qualitatively
based on the visual inspection of the CFP by the investigator. Total lesion area is defined as contiguous area of abnormal tissue that will include blood, scars, neovascularization, fibrosis and atrophy.
4) Any infectious conjunctivitis, keratitis, scleritis, endophthalmitis, infectious blepharitis in either eye within 4 weeks prior to Baseline.
5) Any active intraocular inflammation (grade trace or above) in the study eye within 4 weeks prior to Baseline.
6) History of idiopathic or autoimmune-associated uveitis in either eye.
7) CNV in the study eyes due to causes other than AMD such as DME, RVO, histoplasmosis, trauma, multifocal choroiditis, angioid streaks, history of choroidal rupture or pathologic myopia (spherical equivalent of -6 dioptres or more negative) or CNV lesion not likely to respond to anti-VEGF.
8) Participants with coexisting CNV lesions secondary to AMD in the non-study eye that would
require simultaneous treatment with anti-VEGF therapies during the study period.
9) Prior interventions in the study eye Prior Treatment with verteporfin, laser photocoagulation, external beam radiation
treatment and Transpupillary thermotherapy (a) within 5 years prior to randomization if it
involves the fovea in the study eye; OR (b) within 3 months prior to randomization if anywhere beyond fovea in the study eye. Prior vitrectomy in the study eye. Prior glaucoma filtration surgery in the study eye. Prior corneal transplant in the study eye. Sub-macular surgery or any surgical intervention for AMD in study eye. Prior ocular surgery (including cataract) within the previous 2 months from baseline in the study eye.
10) Prior treatment with Any prior anti-VEGF, including but not limited to Ranibizumab, bevacizumab, aflibercept and pegaptanib (intravitreal or systemic) in either eye. Previous treatment with intravitreal steroids (e.g., triamcinolone, anecortave acetate) in the study eye within 3 months prior to randomization or intravitreal steroid implant (like Ozurdex) within 6 months prior to randomization.
11) Known allergies, hypersensitivity, or intolerance to any of the study interventions, or
components excipients thereof [Refer Investigators Brochure (IB) of bevacizumab[5] and
Indian Prescribing Information (PI) of Ranibizumab [6]/Summary of Product Characteristics (SmPC) of Ranibizumab[7] ], or to drugs of similar chemical class or to fluorescein or any other
component of fluorescein formulation or to topical anaesthetics or mydriatic medications. The
participant should not be hypersensitive to any of the drugs, components of the drugs, or essential supportive drugs that are required to be used during treatment or evaluation.
12) Current or planned use of systemic medications known to be toxic to the lens, retina or optic
nerve, including deferoxamine, chloroquine hydroxychloroquine, tamoxifen, phenothiazines and ethambutol.
13) History or evidence of the following in the study eye at Screening and or baseline visit: Retinal pigment epithelium (RPE) rip tear involving the macula at Screening or Baseline in the study eye. Current vitreous haemorrhage or history of vitreous haemorrhage within 4 weeks prior to Baseline in the study eye. Any macular abnormality (including a history of macular hole stage 2 and above) other than AMD at Screening. Uncontrolled glaucoma in the study eye (defined as intraocular pressure (IOP) greater than or equal to 30 mmHg despite treatment with antiglaucoma medication) and any such condition for which the investigator feels may require a glaucoma-filtering surgery while in the study. For participants who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error in the study eye does not exceed 8 dioptres of myopia. Advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye at Screening or Baseline. Aphakia and or absence of the posterior capsule at Screening or Baseline in the study eye Absence of an intact posterior capsule is allowed if it occurred as a result of Yttrium- Aluminium-Garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens (IOL) implantation. Rhegmatogenous retinal detachment in the study eye at Screening or Baseline.
14) Presence of hepatitis B surface antigen (HBsAg) at screening or within 3 months prior to the first dose of investigational intervention
15) Positive hepatitis C antibody test result at screening or within 3 months prior to starting the
investigational intervention. NOTE: Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled only if a confirmatory negative hepatitis C RNA test is obtained.
16) Has known human immunodeficiency virus (HIV) seropositive status, or positive HIV antibody
test at screening. For participants with unknown HIV status, HIV testing will be performed at
screening unless prohibited by local regulations.
17) History of malignancy within the past 5 years except Malignancy treated with curative intent and with no known active disease for at least 3
years before the first dose of study treatment and with low potential risk for risk of metastasis or death (e.g., 5-year OS rate greater than 90 percent). Nonmelanoma skin cancer or lentigo maligna who underwent adequate treatment with no active disease at present. Adequately treated carcinoma in situ without evidence of disease. Localized non-invasive primary disease under surveillance.
18) Documented medical history (within 6 months of screening) of thromboembolic events, stroke,
cerebral infarction, or transient ischemic attacks, peripheral vascular disease, unstable angina pectoris, congestive heart failure or myocardial infarction, clinically significant cardiac diseases like New York Heart Association (NYHA) Grade II or greater, uncontrolled atrial
fibrillation or any other cardiac arrhythmias.
19) Documented medical history of bleeding disorders, including platelet disorders, acquired or hereditary coagulations disorders, and acquired or hereditary vascular disorders.
20) Uncontrolled hypertension (systolic greater than 160 mm Hg or diastolic greater than 100 mm Hg) despite optimal antihypertensive treatment at screening. [If blood pressure is out of range, up to 2 repeated assessments are permitted no more than 60 minutes apart.] Note: Participants may be re-tested or rescreened after initiation or adjustments of antihypertensive medications to establish control.
21) Received any other investigational intervention (including investigational vaccines) or used an
invasive investigational medical device within 30 days or 5 half-lives prior to the first dose of
study intervention, whichever is longer, or is currently enrolled in an investigational study.
22) Previous randomization in the current study regardless of having received the investigational
intervention or not.
23) Any history or evidence of a concurrent intraocular condition in the study eye, including retinal diseases other than neovascular AMD, that in the judgment of the Investigator, could either
require medical or surgical intervention during the course of the study to prevent or treat visual
loss that might result from that condition or that limits the potential to gain visual acuity upon
treatment with the investigational product (e.g. diabetic retinopathy, cataract, uncontrolled
glaucoma, uveitis, previous corneal transplant, recent cataract surgery etc.).
24) History of a medical condition (disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding) that, in the judgment of the Investigator, would preclude
scheduled study visits, completion of the study, or a safe administration of investigational
product, affect interpretation of the results of the study, or renders the participant at high risk
of treatment complications.
25) History of gastrointestinal perforation or fistulae, haemorrhage of any kind (e.g. Hemoptysis), arterial or venous thromboembolism, renal disease, history of unhealed wound or ulcers or planned surgery during study conduct period.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
On-site computer system
Blinding/Masking
Double Blind Double Dummy
Primary Outcome
Outcome
TimePoints
Phase 2: To assess and compare safety of Intas
bevacizumab with Ranibizumab in participants with wet neovascular AMD.
Phase 3: To assess the noninferiority of Intas
bevacizumab to Ranibizumab in participants with wet neovascular AMD.
Pre-dose before first dose (Day 1) and third dose (Day 57), Pre-dose before second dose (Day 29), After first dose (Day 1), 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, After third dose (Day 57) 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, Day 85.
Secondary Outcome
Outcome
TimePoints
Phase 2: To assess and compare efficacy
parameters of Intas bevacizumab with
Ranibizumab in participants with wet
neovascular AMD.
Phase 3: To assess and compare additional
efficacy parameters of Intas
bevacizumab with Ranibizumab in
participants with wet neovascular
AMD.
Pre-dose before first dose (Day 1) and third dose (Day 57), Pre-dose before second dose (Day 29), After first dose (Day 1), 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, After third dose (Day 57) 8.000, 12.000, 16.000, 20.000, 24.000 28.000 hrs, Day 85.
Phase 2:
1) To assess immunogenicity of Intas bevacizumab with Ranibizumab in participants with wet neovascular AMD.
2) To estimate the systemic levels of Intas bevacizumab with Ranibizumab.
Phase 3:
1) To assess and compare safety of Intas
bevacizumab with Ranibizumab in participants with wet neovascular
AMD.
2) To assess immunogenicity of Intas
bevacizumab with Ranibizumab in
participants with wet neovascular
AMD.
Pre-dose before first dose (Day 1, 3 samples) and third dose (Day 57), Day 15, Pre-dose before second dose (Day 29), Day 85.
Target Sample Size
Total Sample Size="204" Sample Size from India="204" 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)
08/09/2025
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="3" 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
Comparative Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of Intas Bevacizumab and Ranibizumab Intravitreal Injection in Participants with Neovascular (wet) Age-Related Macular Degeneration