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CTRI Number  CTRI/2018/05/014065 [Registered on: 23/05/2018] Trial Registered Prospectively
Last Modified On: 26/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy and safety of R-TPR-024 / Lucentis® in patients with neovascular (wet) age-related macular degeneration  
Scientific Title of Study   Prospective, multi-center, randomized, double-blind, two-arm, parallel group, active control, comparative clinical study to evaluate efficacy and safety of R-TPR-024 / Lucentis® in patients with neovascular (wet) age-related macular degeneration  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
RLS/OPT/2016/06 V 2, dated 23 Jan 17  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jamila Joseph 
Designation  SVP-RLS Clinical Trial Group 
Affiliation  Reliance Life Sciences Pvt. Ltd. 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone    
Fax    
Email  jamila.joseph@ril.com  
 
Details of Contact Person
Scientific Query  
Name  Jamila Joseph 
Designation  SVP-RLS Clinical Trial Group 
Affiliation  Reliance Life Sciences Pvt. Ltd. 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone    
Fax    
Email  jamila.joseph@ril.com  
 
Details of Contact Person
Public Query  
Name  Ravikiran Payghan 
Designation  Manager-RLS Clinical Trial Group 
Affiliation  Reliance Life Sciences Pvt. Ltd. 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701

Thane
MAHARASHTRA
400701
India 
Phone    
Fax    
Email  ravikiran.payghan@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. 
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd 
Address  Dhirubhai Ambani Life Sciences Centre Plot R-282, TTC Area of MIDC Thane Belapur Road Rabale, Navi Mumbai 400 701  
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 = 16  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sachin Daigavane  Acharya Vinoba Bhave Rural Hospital  Department of Ophthalmology, Main building, first floor, Datta Meghe Institute of Medical Sciences (DU), Sawangi (M), Wardha-442004
Wardha
MAHARASHTRA 		 9372910079

drsachin391977@gmail.com 
Dr Rani Sujatha  Dr. B R Ambedkar Medical College  Department of Ophthalmology, Second floor, K G Halli, Bangalore 560045
Bangalore
KARNATAKA 		 9845747518

drranisujatha@gmail.com 
Dr Nita Umesh Shanbhag  Dr. D Y Patil Medical College, Hospital and Research Centre  Department of Ophthalmology, Room No. 47, First Floor, Sector 5, Nerul, Navi Mumbai 400706
Mumbai
MAHARASHTRA 		 9322402424

nita.eye@gmail.com 
Dr Perwez Khan  GSVM Medical College and Hospital, Kanpur  Department of Ophthalmology, Ground Floor, OPD, Swaroop Nagar, Kanpur-208002
Kanpur Nagar
UTTAR PRADESH 		 9451987535

drperwezkhan.research@gmail.com 
Dr Santosh Kumar Mahapatra  JPM Rotary Club Of Cuttack Eye Hospital and Research Institute  Department of Vitreo Retina, CDA, Sector VI, Bidanasi, Cuttack 753014, Odisha, India
Cuttack
ORISSA 		 9437017762

santu_k74@rediffmail.com 
Dr Satish K  K R Hospital   Department of Ophthalmology, Mysore Medical College and Research Institute, Irwin Road, Mysore 570001
Mysore
KARNATAKA 		 9886400414
0821-2526088
drsatishkeshav@gmail.com 
Dr Niveditha H  KIMS Hospital and Research Center  Department of Ophthalmology, B Block, OPD Building, K R Road, V V Puram, Bangalore 560004
Bangalore
KARNATAKA 		 9448821517

drhniveditha@gmail.com 
Dr Vupputuri Venkata Lakshmi Narasimha Rao  King George Hospital  Project Room,Government Regional Eye Hospital, opposite Bullayya College, Resapuvanipalem, Vishakhapatnam 530013, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 		 9885268979
91-891-2555668
vvlclinicalresearch@gmail.com 
Dr Sandeep Saxena  King George Medical University,Lucknow  Department of Ophthalmology, First floor, Near Mahatma Gandhi Ward, Shahmina Road,Chowk, Lucknow-226003
Lucknow
UTTAR PRADESH 		 9415160528

sandeepsaxena2020@yahoo.com 
Dr Rekha Mudhol  KLEs Dr. Prabhakar Kore Hospital and MRC, Belgaum  Department of Ophthalmology, Near Sharavati Ward, NH 4, Nehru Nagar, Belagavi-590010, Karnataka, India
Belgaum
KARNATAKA 		 8312470400

rekhamudhol@gmail.com 
Dr Vivek Dave  L V Prasad Eye Institute  Clinical Research Department, First Floor, Room No. 123,Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Road No. 2, Hyderabad 500034
Hyderabad
TELANGANA 		 7680859900

vivekoperates@yahoo.co.in 
Dr Somesh Aggarwal  M & J Western Regional Institute of Ophthalmology, B J Medical College and Civil Hospital  1st Floor, Retina OPD, Asarwa, Ahmedabad 380016
Ahmadabad
GUJARAT 		 9427029044

dr.somesh@yahoo.com 
Dr Naresh Kumar Yadav  Narayana Nethralaya  Vitreo Retinal Services, Department of Clinical Research, 121/C, Chord Road, 1st R Block, Rajajinagar, Bangalore 560010, Karnataka, India
Bangalore
KARNATAKA 		 9980872120

vasudha.naresh@gmail.com 
Dr Lakshmi Kanta Mondal  Regional Institute of Ophthalmology  Ground floor, OPD No.B109, 88 College Street, Calcutta Medical College and Hospital, Kolkata 700073
Kolkata
WEST BENGAL 		 9830830216

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

rohan_28782@yahoo.co.in 
Dr Shachi Desai  Sanjivani Super Speciality Hospital Pvt. Ltd.  OPD No. 5, First floor, Uday Park Society, Near Sunrise Park, Vastrapur, Ahmedabad- 380015
Ahmadabad
GUJARAT 		 9978897564

drshachidesai@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
Ethics Committee GSVM Medical College, Kanpur  Approved 
Ethics Committee of King George Medical University,Lucknow  Approved 
Ethics Committee, KLE University, Belgaum  Approved 
Institutional Ethics Committee KIMS  Approved 
Institutional Ethics Committee, , Dr. B R Ambedkar Medical College  Approved 
Institutional Ethics Committee, B J Medical College and Civil Hospital, Ahmedabad  Approved 
Institutional Ethics Committee, D Y Patil University School of Medicine  Approved 
Institutional Ethics Committee, Datta Meghe Institute of Medical Sciences  Approved 
Institutional Ethics Committee, JPM Rotary Club of Cuttack Eye Hospital and Research Institute, Cuttack  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Institutional Ethics Committee, Mysore Medical College and Research Institute and Associated Hospitals  Approved 
Institutional Ethics Committee, Regional Institute of Ophthalmology, Kolkata  Approved 
L V Prasad Eye Institute Ethics Committee  Approved 
Medilink Ethics Committee  Approved 
Narayana Nethralaya Ethics Committee  Approved 
Sanjivani Hospital Ethics Committee, Ahmedabad  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  neovascular (Wet) age related macular degeneration,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Lucentis®  Ranibizumab 0.5 mg intravitreal injection every 4 weeks for 24 weeks 
Intervention  R-TPR-024  Ranibizumab 0.5 mg intravitreal injection every 4 weeks for 24 weeks 
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Male or female patients of age ≥ 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.
 
 
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 randomization.
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 randomization.
4. CNV in either eye due to other causes, such as ocular histoplasmosis, trauma, or pathologic myopia.
5. Patients with controlled or uncontrolled diabetes mellitus.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
proportion of patients who lost fewer than 15 letters in visual acuity   proportion of patients who lost fewer than 15 letters in visual acuity  
 
Secondary Outcome  
Outcome  TimePoints 
immunogenicity, safety and tolerability of R-TPR-024 / Lucentis®   at week 24 from Baseline 
 
Target Sample Size   Total Sample Size="159"
Sample Size from India="159" 
Final Enrollment numbers achieved (Total)= "159"
Final Enrollment numbers achieved (India)="159" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)
Modification(s)  		 12/07/2018 
Date of Study Completion (India) 18/11/2019 
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   None Yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   This prospective, multi-centre, double-blind, two-arm, parallel group, active control, randomized comparative clinical trial is being conducted to compare the efficacy and safety of R-TPR-024 vs. Lucentis® in patients with neovascular (wet) age-related macular degeneration (AMD). 
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