CL3-78989-019. The EYEGUARD-X study.
Research type
Research Study
Full title
A Safety Open-Label Study of GevokizUmAb in the Treatment of Patients with Chronic Non-Infectious Uveitis Disease, an Extension Study. The EYEGUARD-X study.
IRAS ID
159329
Contact name
Carlos PAVESIO
Contact email
Sponsor organisation
Servier Research and Development Ltd
Eudract number
2013-004973-29
Duration of Study in the UK
3 years, 11 months, 31 days
Research summary
The aim of this study is to assess the long-term safety of gevokizumab in patients with chronic non-infectious uveitis (inflammatory eye disease). The study will last for approximately 2 years.
Gevokizumab is a type of drug called a ‘monoclonal antibody’ and it binds to a protein called ‘IL-1ß’. IL-1ß is thought to play a role in the inflammatory processes observed within the eye in patients with uveitis. By blocking IL-1ß, gevokizumab may help to reduce the inflammation and improve symptoms.
Chronic non-infectious uveitis is a long-lasting condition, involving flare-ups of inflammation within the eye that can lead to loss of vision. Due to the long-term nature of this disease we need to test the long-term safety of gevokizumab.
Patients with uveitis, who have completed previous studies involving the study drug, gevokizumab or placebo, and who have tolerated the study drug well and who may benefit from long-term treatment with gevokizumab 60mg, are invited to take part in this study. Gevokizumab will be administered by subcutaneous injection every 4 weeks from week 0 to week 92, for a total of 24 administrations.
The safety of the study drug will be assessed by regular clinical examination, detailed eye tests and blood samples and by collecting and analysing data of all medical problems reported during the study.
The study will be conducted in around 83 specialist eye units worldwide and around 300 people will take part.
REC name
London - Central Research Ethics Committee
REC reference
15/LO/0163
Date of REC Opinion
7 Apr 2015
REC opinion
Further Information Favourable Opinion