CTRI Trial Data
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PDF of Trial CTRI Website URL - http://ctri.nic.in Clinical Trial Details (PDF Generation Date :- Sun, 26 Sep 2021 17:25:46 GMT) CTRI Number CTRI/2019/05/019097 [Registered on: 13/05/2019] - Trial Registered Prospectively Last Modified On 25/02/2020 Post Graduate Thesis No Type of Trial Interventional Type of Study Biological Study Design Randomized, Parallel Group, Multiple Arm Trial Public Title of Study Comparing the Efficacy and Safety of Xlucane Versus Lucentis® in Patients requiring treatment of wet AMD Scientific Title of Xplore: A Phase III Double-Blind, Parallel Group, Multicenter Study to Compare the Efficacy and Study Safety of Xlucane versus Lucentis® in Patients with Neovascular Age-Related Macular Degeneration Secondary IDs if Any Secondary ID Identifier 2018-002930-19 EudraCT XBR1001 Version 2.0 dated 27 Nov 2018 Protocol Number Details of Principal Details of Principal Investigator Investigator or overall Name Dr Prabhati Mukherji Trial Coordinator (multi-center study) Designation Associate Medical Director Affiliation Kendle India Pvt. Ltd. Address Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III, Gurgaon HARYANA 122001 India Phone Fax Email [email protected] Details Contact Details Contact Person (Scientific Query) Person (Scientific Name Dr Prabhati Mukherji Query) Designation Associate Medical Director Affiliation Kendle India Pvt. Ltd. Address Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III, HARYANA 122001 India Phone Fax Email [email protected] Details Contact Details Contact Person (Public Query) Person (Public Query) Name Abhishek Tyagi Designation Project Director Affiliation Kendle India Pvt. Ltd. Address Building No 14, Tower B, 14th Floor, DLF Cyber City, Phase III Kendle India Private Limited Building 14, Tower B, 14th Floor, DLF Cybercity (SEZ), DLF Phase III Gurgaon HARYANA 122001 page 1 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in India Phone Fax Email [email protected] Source of Monetary or Source of Monetary or Material Support Material Support > Xbrane Biopharma Banvaktsvägen 22 SE-171 48 Solna Sweden Primary Sponsor Primary Sponsor Details Name Xbrane Biopharma Address Banvaktsvägen 22 SE-171 48 Solna Sweden Type of Sponsor Pharmaceutical industry-Global Details of Secondary Name Address Sponsor NIL NIL Countries of List of Countries Recruitment Bulgaria Czech Republic Estonia Hungary India Israel Latvia Lithuania Poland Romania Russian Federation Slovakia Spain Ukraine United States of America Sites of Study Name of Principal Name of Site Site Address Phone/Fax/Email Investigator Dr Sundaran Natarajan Aditya Jyot Eye Plot 153 Road 9 2224177632 Hospital Pvt. Ltd Department of Ophthalmology, Ratina [email protected] Division Room No 1, Major Parmeshwaran RoadOpp. SIWS College Gate 3 Wadala,Mumbai, Maharashtra,400031 Mumbai MAHARASHTRA Dr Ramandeep Singh Advanced eye center department of 9463001620 PGIMER Ophthalmology, Ratina Division, Room # 242, [email protected] Sector 12, 160012 Chandigarh, India Chandigarh CHANDIGARH Dr Ajay Ambade Arneja Heart & Department of 9823178466 Multispeciality Hospital Ophthalmology, Ratina Division, Consulation dr_ajayambade@rediff page 2 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in room, 123 mail.com Ramdaspeth, 440010 Nagpur, India Nagpur MAHARASHTRA Dr Alay Banker Bankers Retina Clinic Ratina clinic, Ratina 9825024655 Laser Centre Division Doctors Room, Subhash Society [email protected] Behind Ishwar Bhuvan, m Ahmedabad, 380009 Gujarat, India Ahmadabad GUJARAT Dr Sachin Diagavane Datta Meghe Institute of Department of 9372910079 Medical Sciences Ophthalmology, Ratina Division, Room # drsachin391977@gmail A/120, Acharya Vinoba .com Bhave Rural Hospital, Sawangi (Meghe), 442004 Maharashtra, India Wardha MAHARASHTRA Dr Aratee Palsule Deenanath Mangeshkar Tarachand-Mohanlal 9822300508 Hospital Bhatewara Eye Department, Ratina [email protected] Division, OPD # 3, m Erandawane Pune, Off Karve Road, 411004 Pune, India Pune MAHARASHTRA Dr Soumen Mandal Disha Eye Hospitals Department of 9830161959 Pvt. Ltd. Ophthalmology, Ratina Division, ROOM #312, [email protected]. 8863A Ghosh Para in Road Barrackpore, 700120 Kolkata WEST BENGAL Dr Manisha Agarwal Dr Shroff s Charity Eye Dr Shroff s Charity Eye 9811584615 Hospital, Department of Ophthalmology, Ratina [email protected] Division, Room #13, 5027 Kedarnath Road Daryaganj, 110002 New Delhi, India New Delhi DELHI Dr Lional Raj Dr. Agarwal Eye Dr.Agarwals Eye 8754411261 hospital Hospital, Department of Ophthal mology, Ratina [email protected] Division, Room-2, om No.10, South bypass road, Vannarpettai, Tirunelveli - 627003, Tamilnadu Tirunelveli TAMIL NADU page 3 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Dr Virendra Agarwal Dr. Virendra laser Department of 9314017147 Phaco Surgery Centre Ophthalmology, Ratina Division, Room 2, [email protected] behind Ford Car Showroom Gandhi Nagar Tonk Road, JAIPUR, 302015 Jaipur RAJASTHAN Dr Chairmaine Government Medical Department of 04952350217 Bridgette Solomon College Ophthalmology, Ratina Division, Consultation charmainebridsolomon Room #Medical College @gmail.com Road, 673008 Kozhikode/Kerala, India Kozhikode KERALA Dr Nilesh Parekh Government Medical Department of 9428408788 college and Sir T Ophthalmology, Ratina Hospital, Division, OPED, [email protected] Bhavnagar-364001, m Gujarat Bhavnagar GUJARAT Dr Perwez Khan GSVM Medical College Department of 8400331200 Ophthalmology, Ratina Division, ROOM # OT & rperwezkhan.research Consultation, Swaroop @gmail.com Nagar, 208002 Kanpur, India Kanpur Nagar UTTAR PRADESH Dr Deepika Singhal Gujarat Medical Department of 07927661190 Education and Ophthalmology, Ratina Research Society Division, ROOM #204, [email protected] GMERS Medical Sola Location, S G om College and General Highway, 380061 Hospital Ahmadabad GUJARAT Dr Atul Hegade H V Desai Eye Hospital Department of Ratina, 9850742792 Ratina Division, ROOM # 229, Mohammadwadi [email protected] Road, 411060 n Pune/Maharashtra, India Pune MAHARASHTRA Dr Premnath Raman JSS Hospital Department of 8212335555 Ophthalmology, Ratina Division, ROOM #1033, [email protected] Mahatma Gandhi Road, Mysore, 570010 Mysore KARNATAKA Dr Pramod Kumar King George Medical Department of 7007103252 University Ophthalmology, Ratina Division, ROOM # 206, pramodkumar2020@re Kamal Center Building, diffmail.com 5th Floor, Shah Mina page 4 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Road, Chowk, 226003 Lucknow, India Lucknow UTTAR PRADESH Dr Smitha K S KLES Dr. Prabhakar Department of 24713504182 Kore Hospital and MRC Ophthalmology, Ratina Division, ROOM #17, [email protected] Nehru Nagar, Belagavi,590010 Belgaum KARNATAKA Dr Divya Balakrishnan L V Prasad Eye Clinical Research 04030612123 Hospital Department, Ratina Division, Room #123, [email protected] Kallam Anji Reddy Campus L.V. Prasad Marg, Banjara Hills, 500034 Andhra Pradesh-Hyderabad, India Hyderabad TELANGANA Dr Bhavik Panchal L V Prasad eye institute Department of 8913984126 Opthalmology, Ratina Division, Room # 1, [email protected] GMR Varalakshmi campus, Hanumanthwaka junction, 530040 Visakhapatnam-Andhra Pradesh, India Visakhapatnam ANDHRA PRADESH Dr Umesh Chandra LV Prasad Eye Institute Department of 9853011697 Behera Ophthalmology, Ratina Division, Room # 1, [email protected] Clinical Research room, MTC Campus, Patia, 751024 Bhubaneshwar/Odisha, India Khordha ORISSA Dr Somesh Aggarwal M J institute of Department of Ratina, 09427029044 Opthalmology Ratina Division, Room # 113, Civil Hospital [email protected] campus, Civil Hospital, 380016 Ahmedabad, India Ahmadabad GUJARAT Dr Shrinivas Joshi M M Joshi Eye Institute Department of 9886401234 Ophthalmology, Rtina Division, Room No [email protected] OPD, Vidyanagar Gokul om Road, Hubli, Karnataka ,580031 Dharwad KARNATAKA page 5 / 17 PDF of Trial CTRI Website URL - http://ctri.nic.in Dr Sudhir Garg Maharaja Agrasen Department of 9811411198 Hospital Ophthalmology, Ratina Division, Room # OPD [email protected] 1, Maharaja Agrasen Hospital, 110026 Delhi, India New Delhi DELHI Dr Keshav Satish Mysore Medical College Department of 8212526088 Research Institute Ophthalmology, Ratina Division, Room #1- drsatishkeshav@gmail. Consultation Room, com Irwin Road Mysore Mysore KARNATAKA Dr Bhodraj Dhavan N K P Salve Institute of Department of 7798266550 Medical Sciences and Ophthalmology, Ratina Lata Mangeshkar Division, Room OPD, bodhrajdhawan@gmail. Hospital Digdoh Hills, Hingna com Road, Nagpur, Maharashtra, 440019 Nagpur MAHARASHTRA Dr Santosh Goppi Narayana Netralaya Department of 08066121300 Krishna Ophthalmology, Ratina division, Room # 09, [email protected] 121C Chord Road 1st R m Block Rajaji Nagar, 560010 Bangalore KARNATAKA Dr Kishor Pahuja Natasha Eye Care Natasha Eye Care & 27607777 Hospital, Research Centre, Department of [email protected] Ophthalmology, Ratina om Division, Rom # 01, Shiv Sai Lane, Building A Sai Saheb, Pimple Saudagar, Pune-411027, Maharastra, India Pune MAHARASHTRA Dr Sribhargava Natesh Nethra Eye Hospital Nethra eye 9342880273 hospital.OPD room, Depratment of Ratina, sribhargava.natesh@g Ratina Devision, No. mail.com 8.80 feet road, RMV 2ND STAGE, Bangalore, Karnataka Bangalore KARNATAKA Dr Deepak Bhojvani Raghudeep Eye Department of Ratina, 7069644087 Hospital Ratina division, Room No. OPD, Near oxford bhojwani.deepak1986 tower, gurukul area, @gmail.com gurukul, Memnagar, near drive in cinema thaltej,