Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar 2019 02:03:17 GMT) CTRI Number Last Modified On 08/08/2018 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2011/12/002309 [Registered on: 29/12/2011] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial Safety and Efficacy of DE-109 injection in patients with active, non-infectious inflammation of middle layer of the eye A Phase III, Multinational, Multicenter, Randomized, Double-Masked, Study Assessing the Safety and Efficacy of Intravitreal Injectio ns of DE-109 (three doses) for the Treatment of active, Non-Infectious Uveitis of the Posterior Segment of the eye Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 070496 Other 2011-001595-19 EudraCT 32-007 Protocol Number NCT 01358266 Designation Affiliation ClinicalTrials.gov Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Details Contact Person (Scientific Query) Dr Saurendra Das Executive Director Excel Life Sciences Phone 0120-4022601 Fax 01204022630 Email Designation Affiliation Excel Life Sciences Pvt Ltd D-62, 1st Floor, Sector-2 Noida Gautam Buddha Nagar UTTAR PRADESH 201301 sauren@excellifesciences.com Details Contact Person (Public Query) Dr Saurendra Das Executive Director Excel Life Sciences Pvt Ltd Excel Life Sciences Pvt Ltd D-62 1st Floor Sector-2 Noida 201301, Uttar Pradesh, Gautam Buddha Nagar UTTAR PRADESH 201301 page 1 / 7
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Phone 01204022600 Fax 01204022630 Email > Santen Incorporated Type of Sponsor Excel Life Sciences Pvt Ltd List of Countries Argentina Austria Brazil Chile Colombia Czech Republic Dominican Republic France Germany Israel Italy Netherlands Peru Poland Spain Turkey United Kingdom United States of America of Principal Investigator sauren@excellifesciences.com Source of Monetary or Material Support Primary Sponsor Details Santen Incorporated 2100 Powell Street, 16th Floor Emeryville, CA 94608 United States of America 415-268-9100 Pharmaceutical industry-global D-62, 1st Floor, Sector-2, Noida-201301, Uttar Pradesh, of Site Site Phone/Fax/Email Dr Rathinam Sivakumar Aravind Eye Hospitals Uvea Clinic, 2nd Floor, & Postgraduate Institute Room No. 25, No. 1, of Ophthalmology Anna Nagar, Madurai - 625020, Madurai TAMIL NADU Dr Alay Suresh Banker Bankers Retina Clinic & Laser Centre Examination Room 5, Subhash Society, Behind Ishvar Bhuvan, Near HL Commerce College Six Road, Navarangpura, Ahmedabad - 380009, Gujarat, 0452-4356123 rathinam@aravind.org 079-26569457 alay.banker@gmail.co m page 2 / 7
Dr Pradeep Venkatesh Dr Manisha Agarwal Dr R P Centre for Ophthalmic Sciences, AIIMS Dr. Shroffs Charity Eye Hospital Dr Shahana Mazumdar ICARE Eye Hospital And Research Centre Dr Somasheila Idimadakala Murthy Dr Soumyava Basu Dr Padmamalini Mahendradas Dr Abhijit Chattopadhyay Dr Manish Prannath Nagpal L. V. Prasad Eye Institute L. V. Prasad Eye Institute Narayana Nethralaya Priyamvada Birla Aravind Eye Hospital Retina Foundation and Eye Research Center Ahmadabad GUJARAT Department of Vitreoretinal Disease & Trauma Dr R P Centre for Ophthalmic Sciences, All Institute of Medical Sciences (AIIMS), Ansari Nagar, 29 Aurobindo Marg, New Delhi-110029, South DELHI Department of Retina, Research Room, 5027, Kedarnath Road, Daryaganj, New Delhi 110002 New Delhi DELHI Department of Retina, Research Room, E-34, Sector 26, NOIDA - 201301, Gautam Buddha Nagar UTTAR PRADESH Department of Clinical Research, 4th Floor, Kallam Anji Reddy Campus, L. V. Prasad Marg, Banjara Hills, Hyderabad - 5500034, Hyderabad ANDHRA PRADESH 011-26593044 venkyprao@yahoo.com 9811584615 manisha@sceh.net 0120-2477600 0120-2556389 shahana.mazumdar@g mail.com 040-30612525 040-23600572 smurthy@lvpei.org Department of Clinical 9937250604 Research, Patia, 6743987130 Bhubaneswar - 751024, basu@lvpei.org Khordha ORISSA Department of Clinical Research, Clinical Research Room, 121/C, Chord Road, Rajaji Nagar, 1st R Block, Bangalore - 560010, Bangalore KARNATAKA Retina Vitreous & Uvea Department, First floor, 10, Loundon Street, Kolkata - 700017 Kolkata WEST BENGAL Near The Underbridge, Shahaibaug, 9845551862 m.padmamalini@gmail. com 03322894343 91-3322894300 abhijitc@gmail.com 9328049653 page 3 / 7
Details of Ethics Dr Mahesh Shanmugam Sankara Eye Hospital Ahmedabad - 380004, Ahmadabad GUJARAT Department of Retina Kundalahalli Gate, Varthur Road, Bangalore - 560037, Bangalore KARNATAKA Dr Jyotirmay Biswas Sankara Nethralaya Department of Uvea K N B I R O, First Floor, Clinical Research Department 18 College Road, Chennai - 600006, Chennai TAMIL NADU Dr Dipankar Das Dr Kasinathan Nachiappan Dr Kalpana Babu Sri Sankaradeva Nethralaya Vasan Eye Care Hospital Vittala International Institute of Ophthalmology Department of Ocular Pathology, Uvea & Neuro-Ophthalmology Services, 96, Basistha Road, Beltola, Guwahati-781028, Assam, Kamrup ASSAM pnilishu@gmail.com 9980056361 shanmugam1998@yah oo.com 044-28271616 044-28254180 drjb@snmail.org 9864207627 dr_dasdipankar@yahoo.com Vitero Retinal Services, 044-39890000 Vasan Eye Care Hospital, No. 383, Anna eyeskasi@yahoo.com Salai, Saidapet, Chennai-600015, Tamil Nadu, Chennai TAMIL NADU Clinical Research Department, 2nd Floor, Site No. 1, 2nd main, 2nd Cross, 7th Block, Banashankari, 3rd stage, Bangalore - 560085. Bangalore KARNATAKA 9880377219 kalpana@prabhaeyecli nic.com of Approval Status Date of Approval Is Independent Ethics? Aditya Jyot Eye Hospital Ethics Aravind Eye Care System Dr.Shroffs Charity Eye Hospital Ethics Ethiclin Ethics Approved 27/07/2012 No Approved 20/12/2014 No Approved 03/03/2015 No Approved 01/09/2014 Yes ICARE Hospital And Approved 12/08/2014 No page 4 / 7
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Research Centre Ethics IEC Consultants Approved 19/02/2013 Yes Institutional Ethics, AIIMS, Delhi L.V. Prasad Eye Institute Ethics, Hyderabad LVPEI Ethics, Bhubaneswar Medica Superspecialty Hospital Ethics Narayana Nethralaya Ethics Sankara Ethics Approved 20/11/2014 No Approved 22/07/2014 No Approved 30/08/2014 No Approved 16/06/2012 Yes Approved 03/10/2011 No Approved 14/11/2011 No Science for Health Approved 08/09/2011 Yes Sri Sankaradeva Nethralaya Institutional Ethics (SSNIEC), 96, Basistha Road, Guwahati-781028, Assam, Vasan Eye Care Ethics Vision Research Foundation Status Approved 10/09/2015 No Approved 17/02/2015 No Approved 29/11/2011 No Date Approved/Obtained 19/12/2014 Health Type Patients Condition Active, Non-Infectious Uveitis of the Posterior Segment of the eye Type Details Intervention DE-109 Nature of Intervention: Active Dose: 44mg (3 injections every 2 months at Day 1, 60 and 120) Frequency: Every two months for a total of three doses (Day 1, 60 & 120) Duration: Not Applicable Route of Administration: Intrvitreal Intervention DE-109 Nature of Intervention: Active Dose: 440mg (3 injections every 2 months at Day 1, 60 and 120) Frequency: Every two months for a total of three doses (Day 1, 60 & 120) Duration: Not Applicable Route of Administration: Intrvitreal Intervention DE-109 Nature of Intervention: Active Dose: 880mg (3 injections every page 5 / 7
Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Method of Concealment Blinding/Masking Age From Age To Gender Details Details Stratified block randomization Centralized 18.00 Year(s) 90.00 Year(s) Both Participant and Investigator Blinded Inclusion Criteria 2 months at Day 1, 60 and 120) Frequency: Every two months for a total of three doses (Day 1, 60 & 120) Duration: Not Applicable Route of Administration: Intrvitreal 1. Ability to give informed consent and attend all study visits 2. Males or females greater than or equal to 18 years of age 3. Have diagnosis of active uveitis determined by the Investigator to be non-infectious based on the subjects medical history, history of present illness, ocular examination, review of systems, physical examination, and any relevant, pertinent laboratory evaluations. If an anterior component is present, it must be less than the posterior component 4. Have active uveitis defined as having 1+ (excluding 1+) vitreous haze score (SUN scale) 5. Best-corrected ETDRS visual acuity letter score of 19 letters or more (20/400 Snellen equivalent) or better in study eye Exclusion Criteria Primary Outcome Outcome Timepoints Proportion of subjects with a vitreous haze score of 0 at Month 5 (Standardized Uveitis Nomenclature [SUN]Photographic scale) Month 5 Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Proportion of subjects with a 2 unit improvement in vitreous haze score at Month 5 Time to achieve a vitreous haze score of 0 Mean change from Baseline in vitreous haze score at Month 5 Proportion of subjects on 5 mg/day of prednisone at Month 5 Mean change from Baseline in ETDRS BCVA at Month 5 Mean change from Baseline in central foveal thickness at Month 5 Change from Baseline in the National Eye Institute (NEI) Visual Functioning Questionnaire-25 (VFQ-25) Total Sample Size=600 Sample Size from =220 Month 5 (Day 150) page 6 / 7
Powered by TCPDF (www.tcpdf.org) 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 30/12/2011 05/09/2011 Years=2 Months=4 Days=0 Closed to Recruitment of Participants Closed to Recruitment of Participants The primary purpose of this study is to evaluate the safety and efficacy of intravitreal injections of DE-109 (low, medium, and high doses) for the treatment of active, non-infectious uveitis of the posterior segment of the eye. DE-109 is formulated as clear, non-aqueous solutions of the drug substance, sirolimus, in a vehicle composed of polyethylene glycol 400 (PEG400) and ethanol for intravitreal (IW) injection. This route of administration is well tolerated in animals. The animal toxicity data of sirolimus is remarkable in demonstrating its safety. page 7 / 7