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CTRI Number  CTRI/2014/07/004726 [Registered on: 10/07/2014] Trial Registered Prospectively
Last Modified On: 08/04/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   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 
Scientific Title of Study   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 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
PSV-FAI-001 Version 3 dated March 22, 2013  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Dr Saurendra Das 
Designation  Executive Director 
Affiliation  Excel Life Sciences Pvt Ltd 
Address  Excel Life Sciences Pvt Ltd D-62, 1st Floor, Sector-2, Noida-201301, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone    
Fax    
Email  sauren@excellifesciences.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Dr Saurendra Das 
Designation  Executive Director  
Affiliation  Excel Life Sciences Pvt Ltd 
Address  Excel Life Sciences Pvt Ltd D-62, 1st Floor, Sector-2, Noida-201301, Uttar Pradesh, India

Gautam Buddha Nagar
UTTAR PRADESH
201301
India 
Phone  01204022600  
Fax    
Email  sauren@excellifesciences.com  
 
Source of Monetary or Material Support  
pSivida Corp 
 
Primary Sponsor  
Name  pSivida Corp 
Address  480 Pleasant Street, Suite 300B Watertown, MA 02472 USA 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Excel Life Sciences Pvt Ltd   D-62 First Floor, Sector-2, Noida-201301, Uttar Pradesh, India 
 
Countries of Recruitment     Germany
Hungary
India
Israel
United Kingdom
United States of America  
Sites of Study
Modification(s)  
No of Sites = 6  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Tejas Himanshu Desai  C.H Nagri Municipal Eye Hospital  Dr. Tejas Himanshu Desai- Associate Professor, C.H Nagri Municipal Eye Hospital, Ellisbridge, Ahmedabad- 380006, Gujarat, India
Ahmadabad
GUJARAT 		 07926400321

dr_tejasdesai@yahoo.com 
Dr Vishal Katiyar  Department of Ophthalmology, King George Medical University  Department of Ophthalmology, King Georges Medical University, Shah Mina Road, Chowk, Lucknow, 226003, UP, India
Lucknow
UTTAR PRADESH 		 09889219570

vishalkatiyar@rediffmail.com 
Dr Soumyava Basu  L.V. Prasad Eye Institute, Bhubaneswar  Dr. Soumyava Basu-Consultant in Retina Vitreous Services, L.V. Prasad Eye Institute, Patia, Bhubaneswar- 751025, Odisha, India
Khordha
ORISSA 		 09937250604

basu@lvpei.org 
Dr Annie Mathai  L.V. Prasad Eye Institute, Hyderabad  Dr. Annie Mathai- Head, Uveitis Services Consultant, L.V. Prasad Eye Institute, Kallam Anji Reddy Campus, L.V. Prasad Marg, Banjara Hills, Hyderbad- 500034, Andhra Pradesh, India
Hyderabad
ANDHRA PRADESH 		 04039892020

anniemathai@lvpei.org 
Dr Sucheta Kulkarni  PBMAs, H.V. Desai Eye Hospital  Dr. Sucheta Kulkarni- Head of Department and Consultant, Medical Retina PBMAs, H.V. Desai Eye Hospital, S. No. 93, Tarawade Vasti, Mohmmadwadi Road, Hadapsar, Pune, Maharashtra- 411060, India
Pune
MAHARASHTRA 		 02026970043

drsucheta.kulkarni@gmail.com 
Dr Kokila G Kamath  Seth G.S. Medical College and KEM Hospital  Dr. Kokila G. Kamath- Associate Professor, Department of Ophthalmology, Seth G.S. Medical College and KEM Hospital, Parel, Mumbai- 400012, Maharashtra, India
Mumbai
MAHARASHTRA 		 02224107000

kokila_g_kamath@hotmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
Ethics Committee, L.V. Prasad Eye Institute, Hyderabad  Approved 
Ethics Committee, PBMAs H. V Desai Eye Hospital  Approved 
Institutional Ethics Committee - I, KEM Hospital  Approved 
Institutional Ethics Committee Office of Research Cell King George Medical University, Lucknow  Approved 
Institutional Ethics Committee, Smt. NHL Municipal Medical College, Ahmedabad (NHLIEC)  Approved 
Institutional ethics Committee,L.V.Prasad Eye Institute,Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  Chronic, Non-Infectious Uveitis affecting the Posterior Segment of the Eye , (1) ICD-10 Condition: H208||Other iridocyclitis,  
 
Intervention / Comparator Agent  
Type  Name  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 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  •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, intra- or peri-ocular injection of corticosteroid
• At the time of enrollment (Day 1), study eye has < 10 anterior chamber cells/HPF and a vitreous haze ≤ grade 2.
• 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 
 
ExclusionCriteria 
Details  • 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 Screening with any IOP-lowering agent in the study eye
• Chronic hypotony (< 6 mmHg)
• 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 
 
Method of Generating Random Sequence   Stratified block randomization 
Method of Concealment   Centralized 
Blinding/Masking   Outcome Assessor Blinded 
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 
Recurrence of uveitis in the study eye [ Time Frame: three years ]
[ Designated as safety issue: No ] 		 Time Frame: three year  
 
Target Sample Size   Total Sample Size="120"
Sample Size from India="45" 
Final Enrollment numbers achieved (Total)= "129"
Final Enrollment numbers achieved (India)="31" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   08/08/2014 
Date of Study Completion (India) 21/03/2018 
Date of First Enrollment (Global)  20/08/2013 
Date of Study Completion (Global) 26/03/2018 
Estimated Duration of Trial   Years="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary   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. 
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