Clinical Trial Details (PDF Generation Date :- Sat, 29 Sep 2018 17:14:38 GMT) CTRI Number CTRI/2008/091/000087 [Registered on: 19/06/2008] - Last Modified On 05/08/2013 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study No Interventional Drug Randomized, Parallel Group, Active Controlled Trial Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (AMD) (VIEW 2) A randomized, double masked, active controlled, phase 3 study of the efficacy, safety, and tolerability of repeated doses of intravitreal VEGF Trap-Eye in subjects with neovascular age-related macular degeneration (AMD) Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 2007-000583-25 EudraCT NCT00637377 Organisation ID:De-05113 Designation Affiliation ClinicalTrials.gov Other Details of Principal Investigator Not Applicable N/A Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr. Manish Garg Phone 02225311448 Fax 02225455080 Email Designation Affiliation Country Medical Director Bayer Pharmaceuticals Private Limited Kolshet Road Thane 400607 manish.garg@bayer.com Details Contact Person (Public Query) Dr. Manish Garg Phone 02225311448 Bayer Pharmaceuticals Private Limited Kolshet Road Thane 400607 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 02225455080 Email > Bayer Schering Pharma AG Type of Sponsor NA List of Countries of Principal Investigator Dr.S.Natarajan manish.garg@bayer.com Source of Monetary or Material Support Bayer Primary Sponsor Details Bayer Healthcare AG Pharmaceutical industry-global of Site Site Phone/Fax/Email Aditya Jyot Eye Hospital Wadala,-400 031 Mumbai Dr.Amod Gupta Advance Eye Center PGIMR,-160012 Chandigarh CHANDIGARH Dr. Narendran VenKatapathy Aravind Eye Hospital Avinashi Road,-641014 Coimbatore TAMIL NADU +91-22-24177600 + 91-22-24177630 drdarshanag@yahoo.co.in +91-172 -2747837 +91-172 -2747837 eyepgi@sify.com +91-422-5360400 +91-422-2593030 narendran@cbe.aravin d.org Dr.R.D Ravindran Aravind Eye Hospital Abhisega Pakkam Road,Tavalai Kuppam Junction, CuddaloreRoad-605007 Pondicherry PONDICHERRY +91-413- 2619100 +91-413- 2618848 rdr@pondy.aravind.org Dr.R.Kim Aravind Eye Hospital Anna Nagar,-625020 Madurai TAMIL NADU Dr. Manisha Agarwal Dr.S.P Garg Dr. Raja Narayan Dr. Tara Prasad Das Dr.Thomas Cherian Dr. Shroff?s Charity Eye Hospital Dr.R.P Center for Ophthalmic Sciences L.V. Prasad Eye Institute L.V. Prasad Eye Institute Little Flower Hospital Trust 5027, Kedar Nath Road,,Daryaganj-110002. New Delhi DELHI Ansari Nagar,AllMS-110029 New Delhi DELHI L.V. Prasad Marg,Banjara Hills-500 034 Hyderabad ANDHRA PRADESH,- Not Applicable N/A P.B No.-23,-683572 Not Applicable +91-452-4356102 +91-452-2530984 kim@aravind.org 011-43524444 011-43528816 sceh@sceh.net +91-11-26589380 +91-11-26589380 dr_spgarg@yahoo.co.in +91-40-30612345 + 91-40-23 548271 narayanan@lvpei.org +91-674-3207018 +91-674-3987130 tpd@bei-lvpei.org +91 484 2452546 +91 484 2452646 page 2 / 6
Details of Ethics Committee N/A Dr. Bhargava Natesh Narayana Netralaya 121/C, Chord Road,Rajaji Nagar,1st R- Block-560010 Bangalore KARNATAKA Dr.Himadri Datta Regional Institute Of Ophthalmlogy Medical College,88 college street-700073 Kolkata WEST BENGAL Dr.Manish Nagpal Retina Foundation Near underbridge,shahi bag-380009 Ahmadabad GUJARAT Dr. Rahul Ashok Shroff Shroff Eye Hospital 222 S.V. Road,Bandra (west)-400050 Mumbai Dr. Tarun Sharma Vision Research Foundation Shankar Netralaya 18,College Road-600 006 Chennai TAMIL NADU tcherian@rediffmail.co m +91-80-23225102 +91-80-23377329 sribhargava.natesh@g mail.com +91-33-22190954 +91-33-22190954 himadreedatta@yahoo. com +91 79 65422199 +91 79 22866381 drmanishnagpal@yaho o.com 0222811863 0222812751 shroffeye@vsnl.com +91-44- 28271616 +91-44- 28254180 dr.taruns@gmail.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Aditya Jyot Eye Hospital Ethics Committee, Wadala, Mumbai Ethics Committee, All Institute of Medical Science, NewDelhi 110029 Ethics Committee, Little Flower Clinical Ethics Committee, Angamaly, Kerala Ethics Sub-Committee, Vision Research Foundation, Sankara Nethralaya, Chennai,600006 Institutional Ethics Committee, Narayana Nethralaya, Bangalore-560010 Institutional Ethics Committee, PostGraduate Institute of Medical Education & Research Chandigarh, Institutional Ethics Committee,Regional Institute of Ophthalmology, page 3 / 6
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Medical College & Hospital, Kolkata 700073 Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. Narendran Venkatapathy Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. R.D Ravindran Board, Arvind Medical Research Foundation, Madurai 625020, Tamil Nadu for Dr. R.Kim L.V. Prasad Eye Ethics Committee for Dr. Raja Narayanan L.V. Prasad Eye Ethics Committee for Dr. Tara Prasad Das Retina Foundation Board, Gujarat Status Approved/Obtained Health Type Date No Date Specified Condition Macular Degeneration Type Details Intervention VEGF Trap-Eye 2.0 mg VEGF Trap-Eye administered every 8 weeks (including one additional 2,0 mg dose at Week 4) during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Intervention VEGF Trap-Eye 0.5 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks Intervention VEGF Trap-Eye 2.0 mg VEGF Trap-Eye administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. page 4 / 6
Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Comparator Agent Ranibizumab 0.5 mg administered every 4 weeks during the first year. Thereafter a dose may be administered as frequently as every 4 weeks, but no less frequently than every 12 weeks. Age From Age To Gender Details Details Centralized 18.00 Year(s) 50.00 Year(s) Both Inclusion Criteria Inclusion Criteria: -Signed informed consent. -Men and women? 50 years of age. -Active primary or recurrent subfoveal CNV lesions secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA in the study eye. -ETDRS best-corrected visual acuity of: 20/40 to 20/320 (letter score of 73 to 25) in the study eye at 4 meters. -Willing, committed, and able to return for ALL clinic visits and complete all study-related procedures. -Able to read, (or, if unable to read due to visual impairment, be read to verbatim by the person administering the informed consent or a family member) understand and willing to sign the informed consent form. Exclusion Criteria Participant, Investigator and Outcome Assessor Blinded Exclusion Criteria: -Any prior ocular (in the study eye) or systemic treatment or surgery for neovascular AMD, except dietary supplements or vitamins. -Any prior or concomitant therapy with another investigational agent to treat neovascular AMD in the study eye. -Any prior treatment with anti-vegf agents in the study eye. -Total lesion size >12 disc areas (30.5 mm², including blood, scars and neovascularization) as assessed by FA in the study eye. -Subretinal hemorrhages that is either 50% or more of the total lesion area, or if the blood is under the fovea and is 1 or more disc areas in size in the study eye (if the blood is under the fovea, then the fovea must be surrounded by 270 degrees by visible CNV). -Scar or fibrosis making up >50% of the total lesion in the study eye. -Scar, fibrosis, or atrophy involving the center of the fovea in the study eye. - Presence of retinal pigment epithelial tears or rips involving the macula in the study eye. -History of any vitreous hemorrhage within 4 weeks prior to Visit 1 in the study eye. -Presence of other causes of CNV in the study eye. -Prior vitrectomy in the study eye. -History of retinal detachment or treatment or surgery for retinal detachment in the study eye. -Any history of macular hole of stage 2 and above in the study eye. -Any intraocular or periocular surgery within 3 months of Day 1 on the study eye, except lid surgery, which may not have taken place within 1 month of Day 1, as long as it is unlikely to interfere with the injection. -History or clinical evidence of diabetic retinopathy, diabetic macular edema or any retinal vascular disease other than AMD in either eye. Primary Outcome Outcome Timepoints The proportion of subjects who maintain vision at page 5 / 6
Powered by TCPDF (www.tcpdf.org) PDF of Trial Week 52, where a subject is classified as maintaining vision if the subject has lost fewer than 15 letters on the ETDRS chart compared to baseline (ie, prevention of moderate vision loss) Secondary Outcome Outcome Timepoints Target Sample Size Mean change from baseline in CNV area at Week 52 [ Time Frame: week 52 The proportion of subjects who gain at least 15 letters of vision at Week 52 Mean change from baseline in total NEI VFQ-25 score at Week 52 Mean change from baseline in BCVA as measured by ETDRS letter score at Week 52 Total Sample Size=0 Sample Size from = Phase of Trial Phase 2/ Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary No Date Specified 04/01/2008 Years= Months=0 Days=0 Completed This study is a phase III, double-masked, randomized, study of the efficacy and safety of VEGF Trap-Eye in patients with neovascular age-related macular degeneration. Approximately 1200 patients will be randomized in Europe, Asia, Japan, Australia and South America. (FPFV in : 25.05.2008) page 6 / 6