Safety and efficacy of ILUVIEN® in children with non-infectious posterior uveitis
Research type
Research Study
Full title
A NON-RANDOMISED, OPEN-LABEL, UNCONTROLLED, MULTI-CENTRE, PHASE IIIB STUDY EVALUATING THE SAFETY AND EFFICACY OF FLUOCINOLONE ACETONIDE 190 MICROGRAMS INTRAVITREAL IMPLANT IN PAEDIATRIC SUBJECTS FROM 6 YEARS TO LESS THAN 18 YEARS WITH RECURRENT NON INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE EYE
IRAS ID
1006464
Contact name
Sophie Griffin
Contact email
Sponsor organisation
Alimera Sciences Europe Limited
Eudract number
2022-001622-29
Research summary
The clinical trial ALI-P01-21-006 will evaluate the safety and efficacy of ILUVIEN 190µg in pediatric patients aged 6 years to 17 years old with recurrent non-infectious uveitis affecting the posterior segment of the eye. Posterior uveitis is an inflammation of the choroid, the back part of the uvea, and can also affect the retina. The ILUVIEN implant will be injected into the eye to provide a steady release of fluocinolone acetonide over 36 months. Patients will attend post treatment visits on day 7 and 28 and then long term follow up visits at month 2 and month 3 and then subsequently every three months up to 36 months.
Chronic non-infectious uveitis requires long term medical care. The current standard of care includes systemic corticosteroids and non-steroidal immunosuppressive agents, however long term use of systematic corticosteroids is associated with ocular side effects and may not be as effective in the treatment of posterior uveitis due to insufficient drug reaching the uvea tissue because of the blood-eye barrier.
ILUVIEN intravitreal implant is a sustained-release intravitreal drug deliver system that will be injected into the vitreous cavity of the eye, the intravitreal implant will slowly release fluocinolone acetonide (0.2µg FA/day) over a period of 36 months. The intravitreal delivery mechanism aims to reduce systemic exposure and minimise side effects.
ILUVIEN was approved for use in adults with non-infectious uveitis in March 2019. This clinical trial will evaluate the safety and efficacy of ILUVIEN in pediatric patients with non-infectious uveitis affecting the posterior segment of the eye
REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0236
Date of REC Opinion
7 Jul 2023
REC opinion
Further Information Favourable Opinion