STUDY OF FAI INSERT IN SUBJECTS WITH CHRONIC NON-INFECTIOUS UVEITIS
Research type
Research Study
Full title
A Phase 3, Multi-National, Multi-Center, Randomized, Marked, 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.
IRAS ID
135718
Contact name
Carlos Pavesio
Contact email
Sponsor organisation
pSivida Corporation
Eudract number
2013-001810-14
Clinicaltrials.gov Identifier
Research summary
This is a phase 3 randomised, masked study to assess the safety and effectiveness of a fluocinolone acetonide intravitreal (FAI) insert in subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. The study is funded by pSivida Corp.
Uveitis is an inflammation of the middle layer of the eye called the uvea. It causes visual loss and macular oedema and has been estimated to be responsible for approximately 10% of blindness in the US. Uveitis is often a chronic disease requiring long-term treatment.
Standard treatment currently involves local administration of corticosteroids (in the form of eye drops, an injection, or an implantable insert) and/or systemic administration of steroids or immunosuppressants. The goal of these treatments is to suppress the inflammation in the back of the eye. However, there are disadvantages with existing therapies including side effects and ineffective delivery.
pSivida Corp. is developing an intravitreal insert that contains 0.18mg of flucinolone acetonide (FA) and releases FA at a target rate of 0.2µg FA/day for 36 months. The drug in the insert, FA, is currently used in a surgical implant, Retisert, which is approved by the FDA to treat non-infectious posterior uveitis
The FAI insert has been designed to provide local steroid therapy to the eye for an extended period of time with the goal of preventing the recurrence of uveitis.
Approximately 120 adults will be enrolled from 40-50 sites worldwide. Approximately 15 participants will be recruited in the UK with participation expected to be 37 months.
Subjects will be randomized (2:1) to receive either a FAI insert or a sham injection in the designated study eye. The study will involve screening, treatment day (Day 1) and follow up visits at Days 7, 28 and Months 2, 3, 6, 9, 12, 18, 24, 30 and 36.
Study assessments will involve medical history, demographics, laboratory tests, eye examinations, physical examinations and visual assessments.
REC name
London - Surrey Borders Research Ethics Committee
REC reference
13/LO/1320
Date of REC Opinion
5 Nov 2013
REC opinion
Further Information Favourable Opinion