Clinical Trial Details (PDF Generation Date :- Sat, 09 Mar 2019 11:07:43 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/2014/07/004726 [Registered on: 10/07/2014] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial To assess the safety & efficacy of Fluocinolone Acetonide Intravitreal (FAI) insert in patients with Chronic, Non-Infectious Uveitis affecting the Posterior segment of the Eye A Phase III, Multinational, Multiceneter, Randomized, Masked, Controlled, Safety and Efficacy study of a Fluocinolone Acetonide Intravitreal (FAI) Insert in Subjects with Chronic Non-Infectious Uveitis affecting the Posterior Segment of the Eye Secondary IDs if Any Secondary ID Identifier Details of Principal Investigator or overall Trial Coordinator (multi-center study) PSV-FAI-001 Version 3 dated March 22, 2013 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Email Designation Affiliation Phone Fax Email Designation Affiliation Details Contact Person (Scientific 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 sauren@excellifesciences.com Details Contact Person (Public Query) Dr Saurendra Das Executive Director Excel Life Sciences Pvt Ltd Phone 01204022600 Excel Life Sciences Pvt Ltd D-62, 1st Floor, Sector-2, Noida-201301, Uttar Pradesh, Gautam Buddha Nagar UTTAR PRADESH 201301 page 1 / 6
Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study Fax Email > psivida Corp Type of Sponsor Excel Life Sciences Pvt Ltd List of Countries Germany Hungary Israel United Kingdom United States of America of Principal Investigator Dr Tejas Himanshu Desai Dr Vishal Katiyar Dr Soumyava Basu Dr Annie Mathai sauren@excellifesciences.com Source of Monetary or Material Support Primary Sponsor Details psivida Corp 480 Pleasant Street, Suite 300B Watertown, MA 02472 USA Pharmaceutical industry-global D-62 First Floor, Sector-2, Noida-201301, Uttar Pradesh, of Site Site Phone/Fax/Email C.H Nagri Municipal Eye Department of Ophthalmology, King George Medical University L.V. Prasad Eye Institute, Bhubaneswar L.V. Prasad Eye Institute, Hyderabad Dr. Tejas Himanshu Desai- Associate Professor, C.H Nagri Municipal Eye, Ellisbridge, Ahmedabad- 380006, Gujarat, Ahmadabad GUJARAT Department of Ophthalmology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, 226003, UP, Lucknow UTTAR PRADESH Dr. Soumyava Basu-Consultant in Retina Vitreous Services, L.V. Prasad Eye Institute, Patia, Bhubaneswar- 751025, Odisha, Khordha ORISSA 07926400321 dr_tejasdesai@yahoo.c om 09889219570 vishalkatiyar@rediffmail.com 09937250604 basu@lvpei.org Dr. Annie Mathai- 04039892020 Head, Uveitis Services Consultant, L.V. Prasad anniemathai@lvpei.org Eye Institute, Kallam Anji Reddy Campus, L.V. Prasad Marg, Banjara Hills, page 2 / 6
Details of Ethics Committee Regulatory Clearance Status from DCGI Health Condition / Problems Studied Dr Sucheta Kulkarni Dr Kokila G Kamath PBMAs, H.V. Desai Eye Seth G.S. Medical College and KEM Hyderbad- 500034, Andhra Pradesh, Hyderabad ANDHRA PRADESH Dr. Sucheta Kulkarni- Head of Department and Consultant, Medical Retina PBMAs, H.V. Desai Eye, S. No. 93, Tarawade Vasti, Mohmmadwadi Road, Hadapsar, Pune, Maharashtra- 411060, Pune MAHARASHTRA 02026970043 drsucheta.kulkarni@gm ail.com Dr. Kokila G. Kamath- 02224107000 Associate Professor, Department of kokila_g_kamath@hot Ophthalmology, Seth mail.com G.S. Medical College and KEM, Parel, Mumbai- 400012, Maharashtra, Mumbai MAHARASHTRA of Committee Approval Status Date of Approval Is Independent Ethics Committee? Ethics Committee, L.V. Prasad Eye Institute, Hyderabad Ethics Committee, PBMAs H. V Desai Eye Institutional Ethics Committee - I, KEM Institutional Ethics Committee Office of Research Cell King George Medical University, Lucknow Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad (NHLIEC) Institutional ethics Committee,L.V.Prasad Eye Institute,Bhubaneswar Status Approved 08/11/2016 No Approved 13/10/2016 No Approved 24/12/2016 No Approved 23/01/2017 No Approved 08/03/2017 No Approved 28/01/2017 No Date Approved/Obtained 20/06/2014 Health Type Patients Condition Chronic, Non-Infectious Uveitis affecting the Posterior Segment of the Eye page 3 / 6
Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Type Details Intervention Fluocinolone Acetonide Intravitreal Insert One injection, Once in 36 months, Intravitreal injection Comparator Agent Sham Sham Injection, Once in 36 months, this procedure will consist of pressing the blunt end of the needle against the sclera of the eye with approximately the same pressure as would be used during the injection of a FAI insert; no ocular tissue will be penetrated Age From Age To Gender Details Details 18.00 Year(s) 99.00 Year(s) Both Inclusion Criteria Male or non-pregnant female at least 18 years of age at time of consent One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis > 1 year duration During the 12 months prior to enrollment (Day1), the study eye has either received treatment: systemic corticosteroid or other systemic therapies given for at least 3 months, and/or at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis OR the study eye has experienced recurrence: at least 2 separate recurrences of uveitis requiring systemic, intraor peri-ocular injection of corticosteroid At the time of enrollment (Day 1), study eye has Visual acuity of study eye is at least 15 letters on the ETDRS chart Subject is not planning to undergo elective ocular surgery during the study Subject has ability to understand and sign the Informed Consent Form Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Age eligible fo the study: 18 years & older Exclusion Criteria Allergy to fluocinolone acetonide or any component of the FAI insert History of posterior uveitis only that is not accompanied by vitritis or macular edema History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze Uveitis with infectious etiology Vitreous hemorrhage Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma) Ocular malignancy in either eye, including choroidal melanoma Toxoplasmosis scar in study eye or scar related to previous viral retinitis Previous viral retinitis Media opacity precluding evaluation of retina and vitreous Peripheral retinal detachment in area of insertion Current diagnosis of any form of glaucoma Intraocular pressure (IOP) > 21 mmhg or concurrent therapy at page 4 / 6
Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Centralized Outcome Assessor Blinded Screening with any IOP-lowering agent in the study eye Chronic hypotony ( Ocular surgery on the study eye within 3 months prior to study Day 1 Capsulotomy in study eye within 30 days prior to study Day 1 Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1 Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1 Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1 Prior peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1 Subjects requiring chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or systemic immunosuppressive therapy to manage non-ocular disease Excluding certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to study Day 1 Subjects who have tested positive for human immune deficiency virus (HIV) Systemic infection within 30 days prior to study Day 1 Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the subject inappropriate for entry into this study Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study Treatment with an investigational drug or device within 30 days prior to study Day 1 Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years Primary Outcome Outcome Timepoints Recurrence of uveitis in study eye [ Time Frame: one year ] [ Designated as safety issue: No ] Time Frame: one year Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial Phase 3 Date of First Enrollment () Date of First Enrollment (Global) Recurrence of uveitis in the study eye [ Time Frame: three years ] [ Designated as safety issue: No ] Total Sample Size=120 Sample Size from =45 08/08/2014 20/08/2013 Time Frame: three year page 5 / 6
Powered by TCPDF (www.tcpdf.org) Estimated Duration of Trial Recruitment Status of Trial (Global) Recruitment Status of Trial () Publication Details Brief Summary Years=3 Months=0 Days=0 Closed to Recruitment of Participants Closed to Recruitment of Participants This is a phase 3, multi-national, multi-center, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable fluocinolone acetonide intravitreal (FAI) insert for the management of subjects with non-infectious uveitis affecting the posterior segment of the eye. Patients will be randomized to receive either a sham injection or the FAI insert and will be observed for three years following treatment. page 6 / 6