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 Study
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)
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
(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"
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.