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
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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
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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
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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
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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
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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, AHMEDABAD,
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Gujarat, 380052 Ahmadabad GUJARAT Dr Rohan Chauhan Rising Retina Clinic Department of 9825203022 Ophthalmology, Ratina Division, Room # 1, [email protected] 312-313 Iscon Centre, o.in Shivranjani Cross Roads, Satellite, 3800015 Ahmedabad, India Ahmadabad GUJARAT Dr Santosh Bhide Ruby Hall Clinic Department of 9822300504 Ophthalmology, Ratina Division, ROOM #1, bhidesantoshpune@gm Ruby Hall Clinic, 40 ail.com Sassoon Road, Pune-411001 Pune MAHARASHTRA Dr Arti Elhance Sam Eye Hospital Department of 9956035195 Ophthalmology, Ratina Division, OPD room, [email protected] Hazratganj Rana Pratap Marg, Lucknow-226001, Uttar Pradesh Lucknow UTTAR PRADESH Dr Prabhu Shanker Sankara Eye Hospital Department of 9443186568 Ophthalmology, Ratina Division, OPD room, drprabhushanker@gma Sathy il.com RoadSivanadapuram, Coimbatore/Tamil Nadu, 641035 Coimbatore TAMIL NADU Dr Rajesh Ramanjulu Sankara Eye Hospital Department of 9036952706 Ophthalmology, Ratina Devision, No 7, [email protected] Raghavendra Nilaya, Siddamma Rd, Dodda kullappa Lyt, Kammanahalli, Bengaluru, Karnataka, 560033 Bangalore KARNATAKA Dr Rahul Shroff Shroff Eye Hospital Department of 09819421625 Ophthalmology, Ratina division, Room # 1, 22 [email protected] S V Road Bandra West, 400050 Mumbai, India Mumbai MAHARASHTRA Dr Tinku Bali Razdan Sir Ganga Ram Department of 9999901122 Hospital Ophthalmology, Ratina
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Division, Room # 1412, [email protected] RAJINDER NAGAR, Sir om Ganga Ram Hospital marg, 110060 New Delhi, India New Delhi DELHI Dr Vishal Agrawal SMS Hospital Department of 9024472330 Ophthalmology, Ratina Division, ROOM # [email protected] OPD, , JLN Marg, m Jaipur, 302004 Rajasthan, India Jaipur RAJASTHAN Dr Aniruddha Maiti Susrut eye foundation Susrut eye foundation 9836552140 and Research Centre and Research Centre, Clinical Research [email protected] Department, Ratina Division, Room No. 4,HB-36A1 Sector III Salt lake, Kolkata, 700106 Kolkata WEST BENGAL Dr Saroj Sahdev TN Medical College and Department of 00912223027661 BYL Nair Hospital Ophthalmology, Ratina Division, Room # 10, [email protected] Dr. AL Nair Road Mumbai Central, 400008 Maharashtra, India Mumbai MAHARASHTRA Dr Ezhil Vedhan K Vinayaka Missions Department of 9372910079 Kirupananda Variyar Ophthalmology, Ratina Medical College Division, Room # 1 drsachin391977@gmail Clinical Research, .com Salem, 636308 Tamil Nadu, India Salem TAMIL NADU Details of Ethics Name of Committee Approval Status Date of Approval Is Independent Ethics Committee Committee? Aditya Jyot Eye Submittted/Under No Date Specified No Hospital Ethics Review Committee, Aditya Jot Eye Hospital, 2nd Floor, Plot no.153, Road No 9, Major Parmeshawaran Road, Near SIWS College, Wadala, Mumbai-400031, Maharashtra Arneja’s Intitutional Approved 02/04/2019 No Ethics Committee, Arneja Heart & Multispeciality Hospital, 3rd Floor, 123
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Ramdaspeth, Nagpur 440010, Maharashtra Disha Eye Hospitals Submittted/Under No Date Specified No Ethics committee, Review S8863A Ghosh Para Road Barrackpore, 700120 West Bengal/Kolkata, India Dr. Shroff’s Charity Submittted/Under No Date Specified No Eye Hospital Ethics Review Committee, 5027, Kedarnath Road, Daryaganj, New Delhi, Delhi 110002 Dr.Agarwals Eye Approved 29/04/2019 No Hospital Institutional Review Board, Dr.Agarwals Eye Hospital, No.10, South bypass road, Vannarpettai, Tirunelveli - 627003, Tamilnadu Ethics Committee of Approved 20/09/2019 No SMS Medical College & Attached Hospital – 302004. Office of Ethics Committee , Allergy Clinic, Dhanwantri OPD Block, SMS Hospital, JLN Marg, Jaipur - 302004 Ethics Committee, Submittted/Under No Date Specified No G.S.V.M Medical Review College, Kanpur Ethics Committee, Submittted/Under No Date Specified No Government Medical Review College, Department of Pharmacology, near S.T. Bus Stand, Jail Road, Bhavnagar-364001, Gujarat, Ethics Committee, Approved 06/05/2019 Yes Iladdevi Cataract & IOL Research Centre, Gurukul Road, Memnagar, Ahmedabad-380052, Gujarat, India Ethics Committee, L V Approved 16/07/2019 Yes Prasad Eye Institute, LV Prasad Eye Institute,Kallam Anji Reddy Campus, L.V Prasad Marg, Banjara Hills, Road No: 2, Hyderabad-500034, Telangana.
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Ethics committee, Submittted/Under No Date Specified No Nirmaya Hospital, Review Behind Jaihind petrol Pump Next to Chinchwad Post office Chinchwand Pune Institute Ethics Submittted/Under No Date Specified No Committee Department Review of research,14th Floor, C wing Supper Speciality Building Deenath Mangeshkar Hospital & Rsearch Centre, Off Karve Road, Erandawane, Pune-411004, Maharashtra Institution Ethics Submittted/Under No Date Specified No Committee, Topiwala Review National Medical College & B.Y.L. Nair Charitable Hospital, Nair Road, Mumbai Central, Mumbai-400008, Maharashtra Institution of Ethics Approved 30/04/2019 No Committee, B. J. Medical College & Civil Hospital, Institution of Ethics Committee, B. J. Medical College & Civil Hospital, Asarwa, Ahmedabad-380016, Gujarat Institutional Ethcis Submittted/Under No Date Specified No Committee Mysore Review Medcial College & Research Institute & Associated Hospitals, K.R. Hospital, Mysore Medical College & Reserrch Institute, Irwin Road, Mysore-570001 Institutional Ethics Submittted/Under No Date Specified No Committee , Room No. Review 614, 6th Floor,Maharaja Agrasen Hosiptal, Maharaja Agrasen Hospital, West Punjabi Bagh,New Delhi-110026. Institutional Ethics Submittted/Under No Date Specified No Committee for SAM Review Eye Hospital, SAM Eye Hospital, 21/3C, Tilak Marg, (off. Rana Pratap Marg), Hazratganj, Lucknow-226001, Uttar
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Prades Institutional Ethics Approved 25/03/2019 No Committee of PBMAs H. V. Desai Eye Hospital, Pune S. No. 93 Tarawade Vasti, Mohammadwadi Road, Hadapsar, Pune Institutional Ethics Submittted/Under No Date Specified No Committee PGIMER, Review Room No. 6006, 6th Floor, P N Chuttani Block, Postgraduate Institute of Medical Educationa and Research, Sector 12, Chandigarh 160012, India Institutional Ethics Approved 25/04/2019 No Committee Poona Medical Research Foundation, E4C to E4F, 4th Floor, Fifth Avenue, Condomonium,Dhole Patil Road,Pune-411001, Maharashtra, India Institutional Ethics Submittted/Under No Date Specified No Committee Research Review House, Near Food Court Datta Meghe lnstitute of Medical Sciences (Deemed University) Sawangi (Meghe), Wardha- 442004, Maharashtra, lndia Institutional Ethics Submittted/Under No Date Specified No Committee, Dr Virendra Review laser Phaco Surgery Centre, Office of IEC, Dr Virendra laser Phaco Surgery Centre, Tonk Phatak, Gandhi nagar, Tonk road, Jaipur – 302015 Institutional Ethics Submittted/Under No Date Specified No Committee, GMERS Review Medical College, Sola, Ahmedabad. Institutional Ethics Submittted/Under No Date Specified No Committee, Review Government Medical College, Kozhikode- 673008, Kerala Institutional Ethics Approved 04/04/2019 No Committee, JSSMC & Hospital, Mysore
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Institutional Ethics Submittted/Under No Date Specified No Committee, KLEs Dr. Review Prabhakar Kore Hospital & MRC Nehru Nagar Belagavi-Karnataka 590010 Institutional Ethics Submittted/Under No Date Specified No Committee, L V Prasad Review Eye Institute. L V Prasad Eye InstituteMTC Campus, Patia, Bhubaneswar-751024, Odisha,India Institutional Ethics Submittted/Under No Date Specified No Committee, N K P Review Salve Institute of Medical Sciences and Lata Mangeshkar Hospital, Digdoh Hills, Hingna Road, Nagpur, Maharashtra, 440019 Institutional Ethics Submittted/Under No Date Specified No Committee, Research Review Cell, Administrative Block, KGMU, Lucknow-226003. Institutional Ethics Submittted/Under No Date Specified No committee, Sankara Review Eye care Institutions, Sathy Road, Sivanadapuram, Coimbatore-641035, Tamil Nadu Institutional Ethics Submittted/Under No Date Specified No Committee, Sankara Review Eye Hospital, Kundalhalli gate, Varthur Main Road, Marthahalli, Banglore-560037, Karanataka, India Institutional Ethics Submittted/Under No Date Specified No committee, Susrut eye Review foundation and Research Centre, Salt Lake city, Kolkata-700106, West Bengal LV Prasad Eye Submittted/Under No Date Specified No Instutute, GMRV Review Campus LV Prasad Eye Instutute, GMRV Campus, Hanumanthwaka Junction, Visakhapatnam, Andhra Pradesh, 530040, India
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Medilink Ethics Approved 06/04/2019 Yes Committee Basement Medilink Hospital , Near Shyamal Cross road , 132 Ft. Ring road , Satellite , Ahmedabad - 380015 Narayana Nethralaya Submittted/Under No Date Specified No Ethics Committee, Review 121/C, Chord road,1 st R block, Rajaji Nagar, Bangalore-560010, India. People Tree Hospitals Approved 03/05/2019 Yes Ethics Committee, 2nd, 2 Main, Tumkur Road, Goraguntepalay, Bangalore-560022, Karnataka, Sangini Hpspital Ethics Submittted/Under No Date Specified No Committee, C/p Sangini Review Hospital,First Floor, Santorini Square, B/h Abhishree Complex, Opp. Star Bazar, Nr. Jodhpur Cross Roads, Satellite, Ahmedabad-380015, Gujrat, India Shroff Eye Hospital Submittted/Under No Date Specified No Ethics Committee Review Shroff Eye Hospital Ethics Committee, 222, S. V. Road, Bandra West, Mumbai 400 050. Sir Ganga Ram Submittted/Under No Date Specified No Hospital, Room No: Review 1496, 4th Floor, Old Building, Old Rajinder Nagar, New Delhi 110060 Sushruta Hospital Submittted/Under No Date Specified Yes Ethics Committee, C/O Review Sushruta Multispecialty Hospital & research Centre private limited, P.B. Road, Vidyanagar, Hubli-580021, Karnataka, India Vinayaka Mission’s Submittted/Under No Date Specified No Kirupananda Variyar Review Medical College & Hospital Institutional Ethics Committee. Seer agapadi,Salem-636308, Tamil Nadu,India. Regulatory Clearance Status Date Status from DCGI Approved/Obtained 02/05/2019
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Health Condition / Health Type Condition Problems Studied Patients Degeneration of macula and posterior pole Intervention / Type Name Details Comparator Agent Intervention Ranibizumab (Xlucane) Xlucane (0.05 mL of 10 mg/mL Intravitreal injection ranibizumab) in the study eye once every 4 weeks for 52 weeks. Comparator Agent Ranibizumab Lucentis (0.05 mL of 10 mg/mL (Lucentis)Intravitreal injection ranibizumab) in the study eye once every 4 weeks for 52 weeks. Inclusion Criteria Inclusion Criteria Age From 50.00 Year(s) Age To 99.00 Year(s) Gender Both Details 1) Written and signed informed consent form obtained at screening, before any study-related procedures.
2) Willingness and ability to undertake all scheduled visits and assessments as judged by the investigator.
3) Newly diagnosed, active subfoveal Choroidal Neovascularization (CNV) lesion secondary to age-related macular degeneration (AMD) in the study eye. Note: Active CNV indicates the presence of leakage as evidenced by Fluorescein Angiography (FA) and intra- or subretinal fluid as evidenced by Optical Coherence Tomography (OCT) which must be confirmed by the central reading center during Screening:
a) The area of CNV must be greater than equal to 50% of the total lesion area in the study eye, and
b) Total lesion area Less than equal to 9.0 Disc Areas (DA) in size (including blood, scars and neovascularization) as assessed by FA in the study eye.
4) Best Corrected Visual Acuity (BCVA) of less than equal to 73 and greater than equal to 49 ETDRS letter score in the study eye, using ETDRS chart (20/40 to 20/100 Snellen equivalent) at Screening.
5) Fellow eye should not be expected to need any anti-VEGF treatment for the duration of study participation.
6) Age greater than equal to 50 years at screening.
7) Male and female subjects of childbearing potential must be willing to completely abstain or agree to use an appropriate method of contraception, from the time of signing informed consent and for the duration of study participation through 3 months, following the last dose of study drug. Exclusion Criteria Exclusion Criteria Details 1) Any previous intervention including pharmacological treatment, laser and/or surgery for wAMD in either eye; (Exception: Vitamin supplementation for AMD prevention). Any previous vitreoretinal surgery in the study eye for any cause. 2) Any previous IVT treatment including any anti-VEGF medications, steroids and/or any other investigational medication in either eye. 3) The use of long-acting steroids, either systemic or intraocular in any eye, in the 18 months before planned initiation of study treatment. (Note: Iluvien® [fluocinolone acetonide intravitreal], current or planned implantation during the study, is prohibited.) 4) Subfoveal fibrosis, atrophy or scarring extending greater than 50% of total lesion area, in the study eye as assessed by the investigator at screening and confirmed by the central reading center prior to randomization. 5) Choroidal neovascularization in either eye due to non-AMD causes (eg, DME, RVO, ocular histoplasmosis or trauma, etc.) as assessed by FA and confirmed by central reading center.
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6) Active or recent (within 28 days prior to randomization) intraocular, extraocular, and periocular inflammation or infection in either eye. 7) History of idiopathic or autoimmune-associated uveitis in either eye. 8) Infectious conjunctivitis, keratitis, scleritis or endophthalmitis in either eye. 9) Unmedicated intraocular pressure (IOP) more then equal to 30 mmHg at Screening in either eye. 10) Topical ocular corticosteroids administered for greater than equal to 30 consecutive days in the study eye within 90 days prior to Screening. 11) Spherical equivalent of the refractive error in the study eye demonstrating greater than 8 diopters of myopia. 12) Corneal transplant or corneal dystrophy in the study eye. History of rhegmatogenous retinal detachment in the study eye. 13) History of macular hole in the study eye. 14) Retinal pigment epithelial tear or rip, involving the macula in the study eye as assessed by FA and confirmed by the central reading center. 15) Current vitreous hemorrhage in the study eye. 16) Subretinal hemorrhage that is greater than equal to 50% of the total lesion area in the study eye, or if the subretinal hemorrhage involves the fovea is 1 or more DA (greater than equal to 2.54 mm2) in size in the study eye, as assessed by FA and confirmed by the central reading center. 17) Other intraocular surgery (including cataract surgery) in the study eye within the 3 months prior to baseline. The yttrium aluminum garnet [YAG] posterior capsulotomy is allowed not later than 4 weeks prior to screening. 18) Any concurrent intraocular condition in the study eye (eg, cataract or diabetic retinopathy) that, in the opinion of the investigator, could require treatment during the study period to prevent or treat loss of visual acuity. 19) Significant media opacities (including cataract) in the study eye interfering with BCVA assessment or fundus imaging (FA/FP/OCT). 20) Aphakia or absence of the posterior capsule in the study eye, unless it occurred as a result of a YAG posterior capsulotomy in association with prior posterior chamber intraocular lens implantation. 21) Presence of advanced glaucoma or optic neuropathy that involve(s) or threaten(s) the central visual field in the study eye (as judged by the investigator). 22) History of glaucoma filtering surgery or argon laser trabeculoplasty in the study eye (Exception: Laser iridotomy and selective laser trabeculoplasty are allowed). 23) Uncontrolled ocular glaucoma or hypertension in the study eye, defined as IOP greater than equal to 25 mmHg despite treatment with anti-glaucoma medication. 24) Any previous systemic anti-VEGF treatment (eg, bevacizumab). Contraindication for Lucentis® (hypersensitivity to ranibizumab or to any of the study treatment excipients). 25) Current treatment for active systemic infection. 26) Females who are pregnant, nursing, planning a pregnancy during the study, or of childbearing potential and not using a reliable method of contraception and/or not willing to use a reliable method of contraception during their participation in the study. 27) Participation in another clinical trial within the previous 3 months or any other clinical trial of anti-angiogenic drugs. 28) Reasonable suspicion of other disease or condition that might render the subject at a high risk of treatment complications or otherwise confound interpretation of the study results (as judged by
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the investigator). 30) PK subgroup only: Contraindication for additional blood sampling (as judged by the investigator). Method of Generating Computer generated randomization Random Sequence Method of Centralized Concealment Blinding/Masking Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded Primary Outcome Outcome Timepoints Change in Best Corrected Visual Acuity (BCVA) [ Time Frame: Week 8 Time Frame: Week 8 ] Change(s) in BCVA letters at Week 8 compared to baseline using the ETDRS protocol Secondary Outcome Outcome Timepoints Change in BCVA using the ETDRS protocol Day 0, Day 1, Week 2, 4, 8, 16, 20, 24, 36 and Total size of choroidal neovascular leakage area 52 measured by FA Total size of choroidal neovascularization measured by FA Central Foveal Thickness measured by OCT Percentage of subjects with loss of 15 letters using ETDRS Percentage of subjects with a gain of ? 15 letters using ETDRS Number of subjects without intra- or subretinal fluid Number of subjects with retinal pigment epithelium detachments Systemic Ranibizumab concentrations Target Sample Size Total Sample Size=580 Sample Size from India=184 Final Enrollment numbers achieved (Total)=Applicable only for Completed/Terminated trials Final Enrollment numbers achieved (India)=Applicable only for Completed/Terminated trials Phase of Trial Phase 3 Date of First 14/05/2019 Enrollment (India) Date of First 14/05/2019 Enrollment (Global) Estimated Duration of Years=1 Trial Months=1 Days=0 Recruitment Status of Open to Recruitment Trial (Global) Recruitment Status of Open to Recruitment Trial (India) Publication Details NIL Brief Summary This is a phase III multicenter, double-blind (double-masked), randomized, parallel group study in subjects with wAMD. Approximately 580 subjects will be enrolled and randomized in a 1:1 ratio to receive either Lucentis® (0.05 mL of 10 mg/mL ranibizumab) or the investigational product (IP), Xlucane (0.05 mL of 10 mg/mL ranibizumab), in the study eye once every 4 weeks for 52 weeks (ie, 12 months).
The study eye will be defined as the eye meeting all of the inclusion criteria and
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none of the exclusion criteria (ie, the enrollment criteria).
The assigned study drug will be administered as an ophthalmic intravitreal (IVT) injection. Designated, unmasked study staff will prepare and administer the study drug, ensuring that the masking of the subject is maintained during the injection procedure. See Section 8.4.6.
Subjects will be randomized by interactive web response system (IWRS) to receive 13 doses of either Xlucane or Lucentis® in the study eye. The randomization scheme will automatically ensure that the study drug assignment for a given subject is random and that an overall 1:1 ratio of assignments to each of the 2 study drug treatments is approximated. In addition, the randomization scheme will include the following stratification parameters to ensure balanced distribution of assignment to the 2 treatments: eye color (light iris vs dark iris), geographical region where enrolled and the BCVA letters at Baseline. Subjects will be followed up for changes in efficacy variables and safety for 52 weeks. Each subject’s involvement will last up to approximately 52 weeks (ie, 12 months).
At the beginning of the study, a subgroup of 60 subjects at a select number of participating sites will be sequentially asked to participate in an evaluation of PK. This subgroup will be asked to provide blood samples for measurement of serum ranibizumab immediately before administration of the first dose of Xlucane or Lucentis®. Additional samples will be collected 23 hours after the first dose (ie, Day 1) and 23 hours after the sixth dose (ie, Week 20) at expected time to maximum serum concentration (Tmax, which is around 22 hours). The primary analysis set will be the Per-Protocol population.
An interim analysis will be performed on unmasked study data. After all of the randomized subjects have 6-month (ie, 24 weeks) data available, an unmasked analysis of efficacy and safety endpoints as well as PK and immunogenicity will be performed. The aim of this analysis is to obtain results prior to completion of full follow-up for all subjects. This analysis will not affect the further conduct of the study.
FA, CFP, and OCT will performed at Screening. The images will be sent to the central reading center (CRC) for interpretation and confirmation of eligibility. The CRC will also grade images that are collected during the study.
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