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1 Clinical Trial Details (PDF Generation Date :- Sun, 02 Sep :38:07 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/2014/12/ [Registered on: 30/12/2014] - Trial Registered Prospectively No Interventional Drug Randomized, Parallel Group, Multiple Arm Trial A research to study the effect of Fluocinolone Acetonide Intravitreal (FAI) Insert in Patients with inflammation of middle layer of the eye A Multi-Center, 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-005 Version 5.0 Dated 10-Mar-2017 Designation Affiliation Protocol Number Details of Principal Investigator Details Contact Person (Scientific Query) Details Contact Person (Public Query) Phone Fax Designation Affiliation Details Contact Person (Scientific Query) Dr Saurendra Das Executive Director Phone Fax Designation Affiliation Excel Life Sciences Pvt Ltd Excel Life Sciences Pvt Ltd D-62, 1st Floor, Sector-2, Noida , Uttar Pradesh, Gautam Buddha Nagar sauren@excellifesciences.com Details Contact Person (Public Query) Dr Saurendra Das Executive Director Excel Life Sciences Pvt Ltd Phone Fax Excel Life Sciences Pvt Ltd Assotech Business Cresterra, Tower-2, 9th Floor, Unit-912 Sector-135, Noida , Uttar Pradesh, Gautam Buddha Nagar page 1 / 8

2 Source of Monetary or Material Support Primary Sponsor Details of Secondary Sponsor Countries of Recruitment Sites of Study > psivida Corp Type of Sponsor Excel Life Sciences Pvt Ltd List of Countries of Principal Investigator Dr Tejas Desai Dr Aratee Palsule Dr Manisha Agarwal Source of Monetary or Material Support Primary Sponsor Details psivida Corp 480 Pleasant Street, Suite 300B Watertown, MA USA Pharmaceutical industry-global Excel Life Sciences Pvt. Ltd. D-62, 1st Floor, Sector-2, Noida , Uttar Pradesh, of Site Site Phone/Fax/ C H Nagri Municipal Eye Deenanath Mangeshkar and Research Centre Dr Shroffs Charity Eye Dr Shahana Mazumdar ICARE Eye and Postgraduate Institute Dr Aparna Mahendru Retina Department, C H Nagri Municipal Eye, Ellisbridge, Ahmedabad Gujarat, Ahmadabad GUJARAT 2nd Floor, Ophthalmology Department, Near Mhatre Bridge, Erandawne, Pune , Maharashtra, Pune MAHARASHTRA Vitreo-Retina Department, Dr Shroffs Charity Eye hospital, 5027, Kedarnath Road, Daryaganj, New Delhi , New Delhi DELHI Retina Department, ICARE Eye and Postgraduate Institute, ICARE Research Centre, E3A, Sector-26, Noida , Uttar Pradesh, Gautam Buddha Nagar JL Rohatgi Eye Department of Ophthalmology, JL Rohatgi Memorial Eye, 117/52, GT Road, Sarvodaya Nagar, Kanpur , Uttar Pradesh, dr_tejasdesai@yahoo.c om palsulea@gmail.com manisha@sceh.net shahana.mazumdar@g mail.com aparnamahendru@yah oo.in page 2 / 8

3 Dr Vishal Katiyar Dr Mudit Tyagi Dr Atul Hegade Dr Jayanta Dutta Dr Nilesh Mohan King Georges Medical University L V Prasad Eye Institute PBMAs H V Desai Eye Regional Institute of Ophthalmology Regional Institute of Ophthalmology OPD Block, First Floor Kanpur Nagar Department Of Ophthalmology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow , Uttar Pradesh, Lucknow ophthallko@gmail.com Smt. Kanuri Santhamma centre for vitreo Retinal dieases, L drmudit@lvpei.org V Prasad Eye Institute, Kallam Anji Reddy Campus,L V Prasad Marg, Banjara Hills, Hyderabad , Andhra Pradesh, Hyderabad ANDHRA PRADESH Retina Department, Room Number 110, PBMAs H V Desai Eye, Sr No 93 Tarawade Vasti, Mohammadwadi Road Hadapsar, Pune , Maharashtra, Pune MAHARASHTRA Retina Department, 4th Floor, Regional Institute of Ophthalmology, 88 College Street, Kolkata , West Bengal, Kolkata WEST BENGAL Indira Gandhi Institute of Medical Sciences Sheikhpura, Patna , Bihar, Sheikhpura BIHAR atulhegade@yahoo.co.i n jayanta.mickey@gmail. com mohannilesh@yahoo.c om Dr Jyotirmay Biswas Sankara Nethralaya Uveitis and Ocular Pathology Department, Sankara Nethralaya, New Number 41, Old Number 18, College Road Nungambakkam, Chennai , Tamil Nadu, Chennai TAMIL NADU drjb@snmail.org Dr Arjun Ahuja Seth G S Medical Department Of page 3 / 8

4 Details of Ethics Committee Dr Radha Annamalai Dr Dipankar Das Dr Chirag Bhatt Dr Asokan Paramasivam College and KEM Sri Ramachandra Sri Sankaradeva Nethralaya Susrut Eye Foundation & Research Center Vasan Eye Care Ophthalmology, OPD Number 36, Ground Floor, Seth G S Medical om College and KEM, Acharya Donde Marg, Parel, Mumbai , Maharashtra, Mumbai MAHARASHTRA 1st Floor, Department of Ophthalmology, G-Block, No-1, drradhaannamalai@yah Ramachandra Nagar, oo.co.in Porur, Chennai , Chennai TAMIL NADU Department of Ocular Pathology, Uvea & Neuro-Ophthalmology Services, 96, Basistha Road, Beltola, Guwahati , Assam, Kamrup ASSAM Retina Department, 4th Floor, Room Number 4, Susrut Eye Foundation and Research Centre, HB-36/A/1, Sector III, Salt Lake City, Kolkata West Bengal, Kolkata WEST BENGAL dr_dasdipankar@yahoo.com chiragretina1@gmail.co m Vitreo Retinal Services, Vasan Eye Care, 383, Anna drpasokan@rediffmail.c Salai, Next to Saidapet om police station, Saidapet, Chennai , Tamil Nadu, Chennai TAMIL NADU of Committee Approval Status Date of Approval Is Independent Ethics Committee? Dr Shroffs Charity Eye Ethics Committee, New Delhi Ethical Committee Susrut Eye Foundation & Research Centre, Kolkata Ethics Committee, Indira Gandhi Institute of Medical Sciences, Sheikhpura, Approved 22/08/2017 No Approved 15/09/2014 No Approved 16/01/2017 No page 4 / 8

5 Patna , Bihar, Ethics Committee, PBMAs H V Desai Eye, Pune ICARE Eye and Post Graduate Institute Ethics Committee, Noida Approved 28/08/2017 No Approved 09/08/2017 No Approved 28/06/2017 No Committee (lec) I, KEM, Mumbai Committee Lata Mangeshkar Medical Foundation s Deenanath Mangeshkar and Research Centre, Near Mhatre Bridge, Erandawne, Pune , Maharashtra, Approved 12/09/2017 No Committee Regional Institute of Ophthalmology, Kolkata Approved 13/09/2017 No Committee, Kanpur Medical Ethics Committee, JL Rohtagi, Kanpur Committee, King George Medical College, Lucknow Committee, Smt NHL Municipal Medical College, Ahmedabad Approved 23/10/2017 No Approved 23/08/2017 No Approved 24/10/2017 No Committee, Sri Ramachandra University, No-1 Ramachandra Nagar, Porur, Chennai , Approved 24/07/2017 No L V Prasad Eye Institute Ethics Committee, Hyderabad Sri Sankaradeva Nethralaya Institutional Ethics Committee (SSNIEC), 96, Basistha Road, Guwahati , Assam, Vasan Medical Research Trust, Approved 18/07/2017 No Approved 19/05/2017 No Approved 13/12/2017 No page 5 / 8

6 Regulatory Clearance Status from DCGI Health Condition / Problems Studied Intervention / Comparator Agent Inclusion Criteria Exclusion Criteria Committee, Chennai Vision Research Foundation Ethics Committee, Chennai Status Approved 11/07/2017 No Date Approved/Obtained 28/01/2014 Health Type Patients Condition Chronic Non Infectious Uveitis Affecting the Posterior Segment of the eye Type Details Intervention Fluocinolone Acetonide Intravitreal Insert One Injection, Once in 36 months(entire study duration), Intravitreal Comparator Agent Sham Injection Sham Injection- This will consist of pressing a blunt rubber needle against the sclera of eye with same pressure as while giving injection. No tissue will be penetrated. Age From Age To Gender Details Details Year(s) Year(s) Both Inclusion Criteria 1.Male or non-pregnant female at least 18 years of age at time of consent 2.One or both eyes having a history of recurrent non-infectious uveitis affecting the posterior segment of the eye with or without anterior uveitis greater than or equal to 1 year duration 3.During the 12 months prior to enrollment (Day1), either the study eye has received treatment: a.systemic corticosteroid or other systemic therapies given for at least 3 months, and/or b.at least 2 intra- or peri-ocular administrations of corticosteroid for management of uveitis OR the study eye has experienced recurrence: c.at least 2 separate recurrences of uveitis requiring systemic, intraor peri-ocular injection of corticosteroid 4.At the time of enrollment (Day 1), study eye has less than 10 anterior chamber cells/hpf and a vitreous haze less than or equal to grade 2. 5.Visual acuity of study eye is at least 15 letters on the ETDRS chart 6.Subject is not planning to undergo elective ocular surgery during the study 7.Subject has ability to understand and sign the Informed Consent Form 8.Subject is willing and able to comply with scheduled visits, treatment plan, laboratory tests and other study procedures Exclusion Criteria 1.Allergy to fluocinolone acetonide or any component of the FAI insert 2.History of posterior uveitis only that is not accompanied by vitritis or macular edema 3.History of iritis only and no vitreous cells, anterior chamber cells or vitreous haze 4.Uveitis with infectious etiology page 6 / 8

7 5.Vitreous hemorrhage 6.Intraocular inflammation associated with a condition other than noninfectious uveitis (e.g. intraocular lymphoma) 7.Ocular malignancy in either eye, including choroidal melanoma 8.Toxoplasmosis scar in study eye or scar related to previous viral retinitis 9.Previous viral retinitis 10.Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye or fungal diseases of ocular structures 11.Media opacity precluding evaluation of retina and vitreous 12.Peripheral retinal detachment in area of insertion 13.Diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmhg) 14.Intraocular pressure (IOP) greater than 21 mmhg or concurrent therapy at Screening with any IOP-lowering pharmacologic agent in the study eye 15.Chronic hypotony (less than 6 mmhg) 16.Ocular surgery on the study eye within 3 months prior to study Day 1 17.Capsulotomy in study eye within 30 days prior to study Day 1 18.Prior intravitreal treatment of study eye with Retisert within 36 months prior to study Day 1 19.Prior intravitreal treatment of study eye with Ozurdex within 6 months prior to study Day 1 20.Prior intravitreal treatment of study eye with Triesence or Trivaris within 3 months prior to study Day 1 21.Peri-ocular or subtenon steroid treatment of study eye within 3 months prior to study Day 1 22.Subjects requiring chronic systemic or inhaled corticosteroid therapy (greater than 15mg prednisone daily) or chronic systemic immunosuppressive therapy 23.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 24.Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV), syphilis or subjects with mycobacterial uveitis or chorio-retinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis. 25.Systemic infection within 30 days prior to study Day 1 26.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 27.Any other systemic or ocular condition which, in the judgment of the investigator, could make the subject inappropriate for entry into this study 28.Treatment with an investigational drug or device within 30 days prior to study Day 1 29.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 30.Subjects unlikely to comply with the study protocol or who are likely to be lost to follow-up within three years page 7 / 8

8 Powered by TCPDF ( PDF of Trial Method of Generating Random Sequence Method of Concealment Blinding/Masking Stratified block randomization Centralized Outcome Assessor Blinded Primary Outcome Outcome Timepoints Recurrence of Uveitis in the study eye within 12 months following the treatment Secondary Outcome Outcome Timepoints Target Sample Size Phase of Trial 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 Recurrence of Uveitis in the study eye Total Sample Size=150 Sample Size from =150 13/02/2015 No Date Specified Years=3 Months=0 Days=0 Not Applicable Closed to Recruitment of Participants within 36 months This is a Phase 3, Multi-center, masked, controlled safety and efficacy study of Fluocinolone Acetonide Intravitreal (FAI) Insert in patients with Chronic non- infectious Uveitis affecting posterior segment of the eye. Patients will be randomized to receive FAI insert or sham injection and will be followed up for 3 years. page 8 / 8