Clinical Trial Details (PDF Generation Date :- Sun, 07 Apr 2019 21:50:45 GMT) CTRI Number Last Modified On 11/03/2019 Post Graduate Thesis Type of Trial Type of Study Study Design Public Title of Study Scientific Title of Study CTRI/2015/07/006025 [Registered on: 17/07/2015] - Trial Registered Prospectively No Interventional Drug Single Arm Trial Assessment of long term safety of DE-109 in patients with non-infectious uveitis of the posterior segment of the eye A Phase IIIb, Multinational, Multicenter, Open-Label Extension Study Assessing the Long-Term Safety of PRN Intravitreal Injections of DE-109 in Subjects with Non-Infectious Uveitis of the Posterior Segment of the Eye Who have Participated in the SAKURA Development Program Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) 32-009, Version 30 Jun 2014 Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Details Contact Person (Scientific Query) Dr Saurendra Das Executive Director Phone 0120-4022600 Fax 0120-4022630 D-62, First Floor, Sector-2, Noida-201301, Uttar Pradesh, Noida 201301 sauren@excellifesciences.com Details Contact Person (Public Query) Dr Saurendra Das Executive Director Phone 0120-4022600 D-62, First Floor, Sector-2, Noida-201301, Uttar Pradesh, Noida 201301 page 1 / 5
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax 0120-4022630 sauren@excellifesciences.com Source of Monetary or Material Support > Santen Incorporated 2100 Powell Street, 16th Floor, Emeryville, CA 94608 Primary Sponsor Details SANTEN INCORPORATED 2100 Powell Street, 16th Floor, Emeryville, CA 94608 Type of Sponsor List of Countries Austria France Germany Italy Poland Turkey United States of America of Principal Investigator Pharmaceutical industry-global Dr Rathinam Sivakumar Aravind Eye Hospital & Post Graduate Institute of Ophthalmology Dr Yog Raj Sharma Dr Manisha Agarwal D-62,1st Floor, Sector 2, Noida-201301, Uttar Pradesh, of Site Site Phone/Fax/ Dr Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS Dr Shroff s Charity Eye Hospital Dr Shahana Mazumdar ICARE Eye Hospital and Post Graduate Institute Uvea Services Department, No.1 Anna Nagar, Madurai-625020, Tamil Nadu, Madurai TAMIL NADU 0452-4356100 0452-2530984 rathinam@aravind.org Room No 272, Second 011-26593188 Floor, Ansari Nagar, 29, 011-26589848 Aurobindo Marg, New yograjsharma@yahoo.c Delhi-110029, om South DELHI Vitreo Retina Department, 5027, Kedarnath Road,Daryaganj, New Delhi-110002, New Delhi DELHI 011-43528888 011-43528816 manisha@sceh.net Retina@ICARE, Room 0120-2477600 Number 11, 12, 13, 14, 0120-2556389 15 and Old Building shahana.mazumdar@g Research Room, mail.com ICARE Research Centre, E- 3A, Sector 26, Noida-201301, Uttar Pradesh, Dr Somasheila L V Prasad Eye Department of Cornea, 040-30612345 page 2 / 5
Details of Ethics Committee Idimadakala Murthy Institute Anterior Segment, 040-23600572 Ocular Immunology and smurthy@lvpei.org Uveitis Services, Room Number 609(B), Kallam Anji Reddy Campus, L V Prasad Marg, Banjara Hills, Hyderabad-500034, Andhra Pradesh, Hyderabad ANDHRA PRADESH Dr Soumyava Basu Dr Kasinathan Nachiappan L V Prasad Eye Institute Vasan Eye Care Hospital Department of Retina 0674-3987183 Vitreous Services, Patia 0674-3987130,Bhubaneswar 751024, basu@lvpei.org Odisha, Khordha ORISSA Vitero Retinal Services Department, 383,Anna Salai, Saidapet, Chennai-600015, Tamil Nadu, Chennai TAMIL NADU 09840380413 044-39922788 eyeskasi@yahoo.com of Committee Approval Status Date of Approval Is Independent Ethics Committee? Dr Shroff Charity Eye Hospital Ethics Committee, Dr Shroffs Charity Eye Hospital, 5027, Kedar Nath Road, Daryaganj, New Delhi-110002, Ethics Committee, AIIMS, Ansari Nagar,29, Aurobindo Marg, New Delhi -110029, ICARE Eye Hospital & Post Graduate Institute Ethics Committee, E-3A, Sector 26, Noida-201301, UP, Approved 22/09/2015 No Approved 11/05/2015 No Approved 10/04/2015 No Institutional Ethics Committee L V Prasad Eye Institute Patia, Bhubaneshwar-751024, Odisha, Approved 01/07/2015 No Institutional Review Board, Aravind Eye Care System, No-1, Anna Nagar, Madurai-625020, Tamil Nadu, L V Prasad Eye Institute Ethics Committee Kallam Anji Approved 18/04/2015 No Approved 10/03/2015 No page 3 / 5
Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Method of Generating Random Sequence Marg, Banjara Hills, Hyderabad-500034, Andhra Pradesh, Vasan Eye Care Ethics Committee, 120 A Bazzar Road, Saidapet, Chennai 600015, Tamil Nadu, Approved 30/04/2015 No Status Date Approved/Obtained 10/06/2015 Health Type Patients Patients Condition Other iridocyclitis Other specified retinal disorders Type Details Intervention DE-109 (Sirolimus) 440 µg of Intravitreal Injection in the Study Eye. Subjects will be treated at the discretion of the investigator, but no more frequently than every 60 days over a period of 12 months Comparator Agent Age From Age To Gender Details Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria 1. Participated in the SAKURA study 2. Received clinical benefit from treatment in the SAKURA study 3. Ability to sign informed consent and attend all study visits Exclusion Criteria 1.Uveitis of infectious etiology 2.Implanted device 3. Suspected or confirmed central nervous system or ocular lymphoma 4.Uncontrolled glaucoma 5.Significant ocular disease 6.Intravitreal injections in the past 60 days 7.Intraocular surgery or treatment 8.Ocular or periocular infection 9.History of herpetic infection 10.Toxoplasmosis or toxoplasmosis scar 11.Ocular malignancy 12.Vitrectomy 13.Allergy or hypersensitivity to study drug 14.Participation in other uveitis device clinical trials within 30 days 15.Any recent systemic condition/infection 16.Immunosuppressive therapy or immunocomprimised 17.Cytomegalovirus infection 18.Malignancy in remission 19.Females who are pregnant or lactating and who are not using adequate contraceptive 20.Medical marijuana or illegal drug use 21.Systemic saroidosis 22.Therapeutic radiation to the head or neck page 4 / 5
Powered by TCPDF (www.tcpdf.org) Method of Concealment Blinding/Masking Open Label Primary Outcome Outcome Timepoints The long-term safety of DE-109 440?g will be 12 months assessed based on adverse events, visual acuity, intraocular pressure, indirect ophthalmoscopy variables, vitreous haze and the use of rescue therapy. Secondary Outcome Outcome Timepoints Target Sample Size Total Sample Size=200 Sample Size from =100 Phase of Trial Phase 3/ Phase 4 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 05/08/2015 29/09/2014 Years=3 Months=4 Days=0 Closed to Recruitment of Participants Closed to Recruitment of Participants This is a multicenter, open-label, extension study of intravitreal injections of the 440?g dose of DE-109 in subjects with non-infectious uveitis of the posterior segment who received any dose of DE-109 and exited the SAKURA program under Santen Protocol 32-007, Amendment 05. Subjects who were randomized and received at least two injections of DE-109 during the first five months of the SAKURA program and obtained clinical benefit from the study medication, as determined by the Investigator, may be considered for entry in this 12-month extension study. The minimum time lag from last injection in the SAKURA program to entry into the current protocol is 60 days. page 5 / 5