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CTRI Number  CTRI/2016/03/006739 [Registered on: 18/03/2016] Trial Registered Prospectively
Last Modified On: 11/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Trial 
Public Title of Study   To study the safety and efficacy of Ranibizumab of Intas Pharmaceuticals Ltd. in patients with visual impairment.  
Scientific Title of Study   A Prospective, Multicenter Clinical Study to Assess Safety, Immunogenicity and Efficacy of Ranibizumab (Intas Pharmaceuticals Limited) for the Treatment of Wet AMD (Age Related Macular Degeneration) 
Trial Acronym  NA 
Secondary IDs if Any
Modification(s)  
Secondary ID  Identifier 
045-15, Version: 2.1, Date: 06/09/2016  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Modification(s)  
Name  Mr Srinivasa Rao 
Designation  Project Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202570  
Fax  07940202021  
Email  srinivasarao@lambda-cro.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Falgun Vyas 
Designation  Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202354  
Fax  07940202021  
Email  falgunvyas@lambda-cro.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Mr Srinivasa Rao 
Designation  Project Manager 
Affiliation  Lambda Therapeutic Research Ltd 
Address  Plot No. 38, Near Silver Oak Club
S. G. Highway, Gota
Ahmadabad
GUJARAT
380061
India 
Phone  07940202570  
Fax  07940202021  
Email  srinivasarao@lambda-cro.com  
 
Source of Monetary or Material Support  
Intas Pharmaceuticals Ltd. Plot No. 423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand, Ahmedabad-382 213 
 
Primary Sponsor  
Name  Intas Pharmaceuticals Ltd 
Address  Plot No. 423/P/A, Sarkhej-Bavla Highway, Moraiya, Tal: Sanand, Ahmedabad-382 213 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NA  NA 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 20  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chinmay Nakhwa  Aditya Jyoti Eye Hospital  Aditya Jyot Eye Hospital Pvt Ltd. Plot No. 153, Road No. 9, Major Parmeshwaran Road, Opp SIWS college, Wadala (West), Mumbai 400031
Mumbai
MAHARASHTRA 
9819343656

drchinmay@adityajyoteyehospital.org 
Dr Vishali Gupta  Advanced Eye Center Post Graduate Institute of Medical Education & Research  Advanced Eye Center Post Graduate Institute of Medical Education & Research Sector 12, Chandigarh 160012
Chandigarh
CHANDIGARH 
9417565506

vishalisara@yahoo.co.in 
Dr Jigar Patel  Aman Hospital and Research Center  15, Shahswat, Opp E.S.I. Hospital, Gotri Road-390021
Vadodara
GUJARAT 
02652354593

jigarpatel5785@gmail.com 
Dr Mallika Goyal  Apollo Research & Innovations  Apollo Research & Innovations 1st Floor, Clinical trial unit, AIMSR building, Apollo Hospitals, Jubilee Hills, Hyderabad - 500096, Telangana India
Hyderabad
ANDHRA PRADESH 
040-23431725

drmallikagoyal1@gmail.com 
Dr Alay Banker  Bankers Retina Clinic & Laser Centre  Bankers Retina Clinic & Laser Centre, 5 Subhash Society, Nr. H L Commerece College Six Road, Navrangpura-380009
Ahmadabad
GUJARAT 
9825024655

alay.banker@gmail.com 
Dr Rahul Mayor  Dr. Shroffs Charity Eye Hospital  Dr. Shroffs Charity Eye Hospital, Dept. of Opthalmology, Room No.11, 5027, Kedar Nath Road, Daryaganj, New Delhi - 110002
New Delhi
DELHI 
9350666633

rahul.mayor@sceh.net 
Dr Raju Sampangi  Gurushree Hi-Tech Multi Speciality Hospital  Department of Opthalmolgy, No. 1558, Opp. Chandra Layout Bus Stand, Chandra Layout, Vijaynagar- 560 040
Bangalore
KARNATAKA 
9880448422

rajusampangi@gmail.com 
Dr Neha Goel  ICARE Eye Hospital & Post Graduate Institute,  ICARE Research Centre, Department of Opthalmolgy, Room no. 9, E-3A, Sector -26, Noida - 201301
Gautam Buddha Nagar
UTTAR PRADESH 
9918429594

drneha@icarehospital.org 
Dr Sandhya Kumar Hedge  K.R. hospital Mysore Medical College & Research Institute  Department of Ophthalmology, lrwin Road road-570001
Mysore
KARNATAKA 
7204546121

drsandhyahedge@gmail.com 
Dr Sandeep Saxena  King Georges Medical University  Department of Ophthalmology, King Georges Medical University, Lucknow - 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 
9936601375

sandeepsaxena2020@yahoo.com 
Dr Soumyava Basu  L V Prasad Eye Institute  L V Prasad Eye Institute, Patia, Bhubaneshwar- 751024, Odisha
Khordha
ORISSA 
06743987108

B.LVPEI-Clinicalresearch@lvpei.org 
Dr Vivek Dave  L V Prasad Eye Institute  L V Prasad Eye Institute, Kallam Anji Reddy Campus, L.V. Prasad Marg, Banjara Hills, Road No:2, Hyderabad-500034
Hyderabad
ANDHRA PRADESH 
7680859900

vivekdave@lvepi.org 
Dr Srinivas Joshi  M. M. Joshi Eye Institute & Research Centre  M. M. Joshi Eye Institute & Research Centre, Gokul Road, Hosar, Hubli- 580021
Dharwad
KARNATAKA 
9886401234

srinivasmjoshi@gmail.com 
Dr Nareshkumar Yadav  Narayana Nethralaya  Narayana Nethralaya, #212/C, Chord Road, 1st R Block, Rajajinagar, Bangalore Karnataka-560010, India
Bangalore
KARNATAKA 
080-66121319

vasudha.naresh@gmail.com 
Dr Shrinatesh Bhargava  Nethra Eye Hospital  Nethra Eye Hospital, 8 Poojary Layout, 80ft road, R M V II stage- 560094
Bangalore
KARNATAKA 
9342880273

sribhargava.natesh@gmail.com 
Dr Vimal Parmar  PBMAs H.V. Desai Eye Hospital  PBMAs H.V. Desai Eye Hospital S.No 93, Tarawade Vasti, Mohammadwadi Road Hadapsar, Pune - 411060
Pune
MAHARASHTRA 
9665237377

info@mahaveereyehospital.com 
Dr Hemanth Murthy  Retina Institute of Karnataka  Retina Institute of Karnataka, No. 122, 5th main road, Chamarajpet, Bangalore- 560018
Bangalore
KARNATAKA 
08022410106

retinakaranataka@gmail.com 
Dr Purva Patwari  Sanjivani Multispecility Hospital  Sanjivani Super Speciality Hospital Pvt Ltd., 1, New Uday Park society, Nr. Sunrise Park, Vastrapur -380015
Ahmadabad
GUJARAT 
9824047403

purvapatwari@gmail.com 
Dr Dhanashree Ratra  Sankara Nethralaya  Sankara Nethralaya 18/41, College Road Nungambakkam Chennai-600006
Chennai
TAMIL NADU 
9940084285

drdad@snmail.org 
Dr Aniruddha Maiti  Susrut Eye Foundation & Research Centre  Susrut Eye Foundation & Research Centre HB-36/A/1, Sector III, Salt Lake City, Kolkata - 700106
Kolkata
WEST BENGAL 
9836552140

write2maiti@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 20  
Name of Committee  Approval Status 
Aditya Jyot Eye Hospital Ethics Committee,  Approved 
Dr. Shroffs Charity Eye Hospital Ethics Committee, Dr. Rahul Mayor  Submittted/Under Review 
Ethics Committee of Care Institute of Medical Sciences, Dr. Alay Banker  Approved 
Icare Eye Hospital & post Graduate Institute EC, Icare Eye Hospital & Post Graduate Institute,Dr. Neha Goel  Approved 
Institutional Ethics Committee Mysore Medical College & Research Institute & Associated Hospitals  Approved 
Institutional Ethics Committee PBMAs H.V. Desai Eye Hospital, Dr. Vimal Parmar  Approved 
Institutional Ethics Committee Post Graduate Institute of Medical Education & Research, Dr. Vishali Gupta  Submittted/Under Review 
Institutional Ethics Committee, Aman Hospital and research Center, Dr Jigar Patel  Approved 
Institutional Ethics Committee, Gurushree Hi-tech Multi Speciality Hospital, Dr. Hemanth Murthy  Approved 
Institutional Ethics Committee, Gurushree Hi-tech Multi Speciality Hospital, Dr. Shrinatesh Bhargava  Approved 
Institutional Ethics Committee, Gurushree Hi-Tech Multispeciality Hospital,Dr. Raju Sampangi   Approved 
Institutional Ethics Committee, King Georges Medical University  Approved 
Institutional Ethics Committee, L V Prasad Eye Institute, Dr. Soumyava Basu  Approved 
Institutional Ethics Committee, Susrut Eye Foundation & Research Centre, Dr. Aniruddha Maiti  Submittted/Under Review 
Institutional Ethics Committee-Clinical Studies (IEC-CS), Apollo Hospitals, Dr. Mallika Goyal  Submittted/Under Review 
L V Prasad Eye Institute Ethics Committee, Dr. Vivek Dave  Submittted/Under Review 
Narayana Nethralaya Ethics Committee, Dr. Nareshkumar Yadav  Submittted/Under Review 
Sanjivani Super Speciality Ethics committe, Dr. Purva Patwari  Approved 
Sushrutha Hospital Ethics Committee  Approved 
Vision Research Foundation Ethics Committee, Dr. Dhanashree Ratra  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  (1) ICD-10 Condition: H353||Degeneration of macula and posterior pole,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Ranibizumab  Dose: 0.5 mg intravitreal injection, Frequency: every 4 weeks, Mode of Administration: Intravitreal injection, Duration of treatment: 24 weeks  
 
Inclusion Criteria  
Age From  50.00 Year(s)
Age To  85.00 Year(s)
Gender  Both 
Details  1. Male or female participant with age ≥ 50 years at the time of screening
2. Active primary or recurrent subfoveal lesion with CNV(choroidal neovascularization) secondary to AMD, involving the foveal center
3. Have a best corrected visual acuity of 20/40 to 20/320 using Early Treatment Diabetic Retinopathy Study chart- ETDRS (Snellen equivalent) in the study eye. (Only one eye will be assessed in the study. If both eyes are eligible, the one with the better visual acuity is selected for treatment and study unless, based on medical reasons, the investigator deemed the other eye the more appropriate candidate for treatment and study).
4. Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
 
 
ExclusionCriteria 
Details  1.Prior treatment with any intravitreal drug, verteporfin or photodynamic therapy in the study eye and/or non study eye within past 3 months before study entry
2.Extrafoveal Laser photocoagulation within 1 month before study entry in the study eye
3.Prior treatment with systemic or intravitreal bevacizumab therapy within last 6 months
4.Subfoveal fibrosis or atrophy in the study eye
5.CNV in either of the two eye due to causes other than AMD such as histoplasmosis or pathological myopia etc
6.Retinal pigment epithelial tear involving the macula in the study eye
7.Any concurrent intraocular condition in the study eye that could either require medical or surgical intervention during the 6 month study period or that could contribute to a loss of best corrected visual acuity over the 6 months study period
8.Active intraocular inflammation or ongoing infection in the study eye
9.Vitreous hemorrhage in the study eye or history of rhegmatogenous retinal detachment or macular hole (stage 3 or 4) in the study eye
10.Any other retinal pathology i.e. CRVO, CRAO etc.
11.Known hypersensitivity to ranibizumab or any of the components of study medication
12.Previous participation in any clinical trial within 1 month before the entry of the study
13.Any other condition that in the opinion of investigator could hamper participation in the study
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
•Incidence of adverse events (AEs) and serious adverse events (SAEs
including any hypersensitivity reactions and significant laboratory
abnormalities
•Percentage of patients developing anti-Ranibizumab antibody after 6
months of treatment.
 
Baseline to week 24 
 
Secondary Outcome  
Outcome  TimePoints 
To assess efficacy of investigational medicinal product in adult patients with wet-AMD.   At the end of study (week 24) 
 
Target Sample Size   Total Sample Size="126"
Sample Size from India="126" 
Final Enrollment numbers achieved (Total)= "126"
Final Enrollment numbers achieved (India)="126" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   21/03/2016 
Date of Study Completion (India) 18/04/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Age-related macular degeneration (AMD) is one of the leading causes of substantial and irreversible vision loss.  Without treatment, the neovascular form of AMD leads to severe quality-of-life loss within a short time period and considerable economic burden. The Food and Drug Administration (FDA) approved ranibizumab for treatment of subfoveal neovascular AMD in June, 2006. It was the first treatment for AMD shown to improve visual acuity in a substantial percentage of patients. Intas’ formulation of Ranibizumab has been approved by the Indian drug authority for sale in Indian market. Marketing authorisation in India was obtained following submission of the results of a comparative efficacy and safety study with Novartis’ Reference product in 104 adult patients of wet AMD receiving 0.5 mg intravitreally every 4 weeks for 12 weeks duration. The proposed study is being undertaken to generate additional safety, immunogenicity and efficacy data of Intas ranibizumab for the treatment of wet AMD in adult patients aged ≥50 years.

 
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