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CTRI Number  CTRI/2021/06/033972 [Registered on: 03/06/2021] Trial Registered Prospectively
Last Modified On: 11/07/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   The purpose of this research study is to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection, manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration. 
Scientific Title of Study   A prospective, multi-center, single arm, open label, study to evaluate safety and efficacy of RanizuRelTM containing Ranibizumab for intra-vitreal injection, manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration. 
Trial Acronym   
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
RLS/OPT/2020/03 Version 2.0; Dated: 28 Jul 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Mr. Ganesh Bagul 
Designation  Head - Clinical Operations 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  RLS Bio - Product Trials Group, DALC, Depart. and division - clinical research, room no B22 block Centre, R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  9820617721  
Fax    
Email  ganesh1.bagul@relbio.com  
 
Details of Contact Person
Scientific Query
Modification(s)  
Name  Dr Shashikumar Singh 
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  RLS Bio - Product Trials Group, DALC, Depart. and division - clinical research, room no B22 block Centre, R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  9555494381  
Fax    
Email  Shashi26.Singh@ril.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr. Vikram Jadhav  
Designation  Project Manager 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  RLS Bio - Product Trials Group, DALC, Depart. and division - clinical research, room no B22 block Centre, R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai

Thane
MAHARASHTRA
400701
India 
Phone  9948664283  
Fax    
Email  Vikram.Jadhav@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt Ltd, Bio - Product Trials Group, DALC, Depart. and division - clinical research, room no B22 block Centre, R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai  
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd 
Address  RLS Bio - Product Trials Group, DALC, Depart. and division - clinical research, room no B22 block Centre, R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai  
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Daigavane  Acharya Vinoba Bhave Rural Hospital  Acharya Vinoba Bhave Rural Hospital, Datta Meghe Institute of Medical Sciences, Department of Ophthalmology, Sawangi (M), Wardha – 442004, Maharashtra, India.
Wardha
MAHARASHTRA 		 9021736568

drsachin391977@gmail.com 
Prof Dr S Natarajan  Aditya jyot eye Hospital   plot no 153 road no 9 major parameswaran road opposite SIWS college gate no 3 Wadala Mumbai 400031
Mumbai
MAHARASHTRA 		 9920241419

prof.drrn@gmail.com 
Dr Ashish Holani  Chintamani Eye and Dental Hospital  CChitamani eye and Dental Hospital, 24 venkatesh nagar, Mahesh Nagar Road, Apex hospital road, near Akashwani signal, Jalna road, Aurangabad 431001, Maharashtra India.
Aurangabad
MAHARASHTRA 		 9923311575

drashishholani@gmail.com 
Dr Nilesh Giri  Dr D Y Patil Medical College, Hospital and Research Centre, Pune  Dr D Y Patil Medical College, Hospital and Research Centre Sant Tukaram Nagar, Pimpri, Pune – 411018
Pune
MAHARASHTRA 		 7776026323

drgirinilesh@gmail.com 
Dr Palanivel Venkatesan  DR. AGARWALS EYE HOSPITAL LTD   #222, T.T.K Road, Alwarpet, Near Raj Park Hotel, Chennai – 600018, Tamil Nadu, India
Chennai
TAMIL NADU 		 9840330821

palvision@yahoo.com 
Dr Amod Nayak  Dr. Agarwals Eye Hospital Ltd, Bangalore,  Dr. Agarwals Eye Hospital Ltd, No 3, Narayanappa Chamber, Narayanappa Garden main Road, Near Forum Mall, Whitefield, Bangalore, Karnataka 560066,
Bangalore
KARNATAKA 		 07760969625

doc_amodnayak@yahoo.co.in 
Dr Jyothsna Rajagopal  Dr. Agarwals Eye Hospital Ltd, Pulikeshi Nagar, Bangalore,  Dr. Agarwals Eye Hospital Ltd, 33, Coles Rd, opp. Bata Showroom, Cleveland Town, Pulikeshi Nagar, Bengaluru, Karnataka 560005
Bangalore
KARNATAKA 		 9980949289

jyothsna.rajagopal@gmail.com 
Dr Lional Raj  Dr. Agarwals Eye Hospital Ltd, Tirunavelli  Dr. Agarwals Eye Hospital Ltd, No 10, South Bypass Road, Vannarpettai, Tirunavelli-627003, Tamil Nadu.
Tirunelveli
TAMIL NADU 		 8754411261

drlionalraj@gmail.com 
Dr Rutuja Deo  Dr. Rutuja Deo  NPK Salve Institute of Medical Sciences and research centre and Lata mangeshkar Hospital Digdoh Hills Hingna Road, Nagpur 440019
Nagpur
MAHARASHTRA 		 0704665091
07104306111
nkpims1@rediffmail.com 
Dr Jagdish Loya  Drushti Eye Institute Pvt., Aurangabad  139, Panchawati , Samarth Nagar, Aurangabad, Maharashtra, India
Aurangabad
MAHARASHTRA 		 9422217555

jagdishl.drushti@gmail.com 
Dr Anjali Sapar  Insight Institute of Opththalmology  Jay Gamesh Samarjya H wing Spine road Pune Nashik Highway Bhosri PUne 411039
Pune
MAHARASHTRA 		 8237113355
020-27239999
info@punelaser.com 
Dr Satish K   K. R. Hospital, Mysore Medical College and Research Institute, Department of Ophthalmology  K. R. Hospital, Mysore Medical College and Research Institute, Department of Ophthalmology, Irwin Road, Mysore – 570001, Karnataka, India.
Mysore
KARNATAKA 		 9886400414

drsatishkeshav@gmail.com 
Dr Smitha K S  KLES Dr. Prabhakar Kore Hospital and MRC  KLES Dr. Prabhakar Kore Hospital and MRC OPD No 17, 1st Floor Nehru Nagar, Belagavi, Karnataka- 590010 , India
Belgaum
KARNATAKA 		 9964319436

Smt_ks@rediffmail.com 
Dr Gaurav Paranjpe  Krishna Institute of Medical college  Krishna Institute of Medical college deemed to be university Karad Pune BAnglore highway 4 Malkapur road Karad 415539
Satara
MAHARASHTRA 		 02164241555
021912164242170
additionalresearchdirector@kimskarad.in 
Dr Puja Negi  M & J Western regional institute   M & J Western regional institute of ophthalmology Manjusari mill compound New civil hospital campus Asawara Ahemdabad 380016
Ahmadabad
GUJARAT 		 9925035087

pujabillore@gmail.com 
Dr Parth Rana  NETRALAYA SUPER SPECIALITY EYE HOSPITAL  NETRALAYA SUPER SPECIALITY EYE HOSPITAL 1st Floor, KayDee House, Above Union Bank of India, Opp. Gujarat Gas, Parimal Garden Cross Road, CG Road, Ahmedabad - 380006. Gujarat, INDIA.
Ahmadabad
GUJARAT 		 7557555755

dr.parth.rana@gmail.com 
Dr Attada Tarakeshwara Rao  R.S.P.R. Government regional Eye Hospital  R.S.P.R. Government regional Eye Hospital, Opp Bullayya College, Resapuvanipalem Visakhapatnam – 530013.
Visakhapatnam
ANDHRA PRADESH 		 9441873644

dratarakeshwararaoresearch@gmail.com 
Dr L K Mondal  Regional Institute of Ophthalmology  Regional Institute of Ophthalmology 88 College Street, Kolkata - 700073, West Bengal, INDIA.
Kolkata
WEST BENGAL 		 9830830216

lakshmi.mondal62@gmail.com 
Dr Rohan Chauhan  Rising Retina Clinic  Rising Retina Clinic, 312-313, ISCON Center, Shivranjani Cross Roads, Satellite, Ahmedabad – 380015, Gujarat, India.
Ahmadabad
GUJARAT 		 9825203022

rohan_28782@yahoo.co.in 
Dr Sandeep Parwal  SMS hospital, Jaipur  Department of Ophthalmology, Charak Bhawan OPD Block, SMS Hospital, Jaipur- 302004,
Jaipur
RAJASTHAN 		 8107474333

sparwal321@gmail.com 
Dr Vinaya Kumar Konana  Vittala International Institute of Ophthalmology,Bengaluru,   Vittala International Institute of Ophthalmology, Site No. 1, 2nd Main, 2nd Cross, Banashankari III Stage, 7th Block, Hoskerehalli, Bengaluru, Karnataka 560085
Bangalore
KARNATAKA 		 8008661059

dr.vini69@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
ACE Independent Ethics Committee, Bangalore  Approved 
ACE Independent Ethics Committee, Bangalore  Approved 
Aditya Jyoti Eye Hospital Ethics Committee, Mumbai  Approved 
Aurangabad Health Care & Research LLP IEC  Approved 
Dr. Agarwals Eye Hospital Ltd, Tirunaveli  Submittted/Under Review 
Dr. Agarwals Eye Hospital-IEC, Chennai  Approved 
Ethics Committee of CIMS  Approved 
Ethics Committee S.M.S Medical College and attached hospitals, Jaipur  Approved 
Ethics Committee, Science for Health, Bangalore  Approved 
Ethics Committee,Dr.D.Y.Patil Vidyapeeth Pune  Approved 
IEC KIMS DEEMED University KARAD, Krishna Institute of Medical Sciences  Approved 
IEC-MMC and RI and Associated Hospital  Approved 
IECSHCCC Shraddha Hospital And Critical Care Center, Aurangabad, Maharashtra  Approved 
Institute Ethics Committee, N P K Salve Institute of Medical Sciences   Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee of DMIMS  Submittted/Under Review 
Institutional Ethics Committee, Insight Institute of Ophthalmology, Pune   Approved 
Institutional Ethics Committee, King George Hospital, Visakhapatnam   Not Applicable 
Institutional Ethics Committee, KLE University  Submittted/Under Review 
Medilink Ethics Committee  Approved 
 
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 
Comparator Agent  NIL  NIL 
Intervention  RaniZuRel  RanizuRelTM has been developed by Reliance Life Sciences Pvt. Ltd. as a similar biological product to the comparator drug Lucentis®. RanizuRelTM was authorized for marketing by CDSCO based upon the data of complete dossier with quality, nonclinical and clinical data of a phase III clinical trial. The marketing authorization was conditional, mandating a phase IV clinical trial in no less than 200 patients. Hence sample size of 220 subjects was selected considering 10% drop outs. This is a prospective, multi-center, single arm, open label, study to evaluate safety and efficacy of RanizuRelTM This clinical trial was designed considering the conditions for marketing authorizations and the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization India, 2016. Study duration of 24 weeks was decided based upon the time required to demonstrate the efficacy as per available literature. The dose was selected based on the available prescribing information of the drug. Dose: 0.5 mg given as a single intra-vitreal injection Frequency: The interval between two doses injected into the same eye should be at least four weeks. Route of Administration: Intravitreal Duration of therapy: 24 weeks.  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  1. Male or female patients of age ≥ 50 years.
2. Active primary or recurrent subfoveal lesions with 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 nonstudy eye within 1 week prior to enrolment.
2. Previous external-beam radiation therapy, transpupillary 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 enrolment.
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 enrolment.
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 history of diabetes mellitus.with HbA1c >8% [64 mmol/mol]
14. Patients who are HIV, HBsAg, HCV test positive.
15. Patients with positive urine pregnancy test at screening.
16. Hypersensitivity to ranibizumab or any of the excipients, or history of allergy to
fluorescein.
17. Participation in any clinical study of an investigational product within previous 3
months.
18. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic,
hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral
disease that renders the patient incapable of participating in the study.
19. 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   Computer generated randomization 
Method of Concealment   Pre-numbered or coded identical Containers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events occurring during the study,  at Day 0 , Week 4, Week 8 , Week 12, Week 16, Week 20 , Week 24 and Withdrawal Visit. 
 
Secondary Outcome  
Outcome  TimePoints 
• Other safety endpoints:

- SAEs, Serious (sight - threatening)Ocular Adverse Events
- Vital signs, physical examination, abnormal laboratory parameters
- Immunogenicity .
 		 • Other safety endpoints:

- All Visits
- All Visits
- baseline, week 12 and 24 or at withdrawal visit) 
• Proportion of patients who lost fewer than 15 letters in visual acuity.  at baseline to week 24 
• Proportion of patients who gained at least 15 letters in visual acuity  at baseline to week 24 
• Mean change in best corrected visual acuity (no. of letters).   at baseline to week 24 
• Proportion of patients with a visual acuity Snellen equivalent of 20/40 or better   at baseline to week 24 
• Proportion of patients with a visual acuity Snellen equivalent of 20/200 or worse   at baseline to week 24 
• Change in central macular thickness assessed by Optical Coherence Tomography   at baseline to week 24 
 
Target Sample Size   Total Sample Size="220"
Sample Size from India="220" 
Final Enrollment numbers achieved (Total)= "220"
Final Enrollment numbers achieved (India)="220" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   15/06/2021 
Date of Study Completion (India) 12/08/2023 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

The purpose of this trial is to evaluate safety and efficacy of RanizuRel containing Ranibizumab for intra-vitreal injection , manufactured by Reliance Life Sciences, Pvt. Ltd. India in patients with neovascular (wet) age-related macular degeneration.

 
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