Long term follow up of Vigabatrin associated retinal toxicity
Research type
Research Study
Full title
Study of long term visual function and plasma biomarkers in patients with epilepsy receiving Vigabatrin.
IRAS ID
164878
Contact name
Kaleena Michael
Contact email
Sponsor organisation
NHS Greater Glasgow and Clyde
Duration of Study in the UK
0 years, 6 months, 6 days
Research summary
The study aims to formally assess the long-term retinal function in patients exposed to Vigabatrin, an anti epileptic drug. Vigabatrin is effective for use in refractory epilepsy and infantile spasms. However, its use worldwide has been restricted by the occurrence of toxic effects on the retina.
Our centre completed a study in 2007, which looked at retinal toxicity in patients exposed to various antiepileptic medications. From the original cohort of 204, 105 participants were exposed to Vigabatrin and will be invited to participate in the proposed study. The primary aim of this study is to assess the progression of retinal toxicity over 10 years duration, as this information is vital but remains unknown at present.The secondary aim of this study is to determine if amino acids taurine and ornithine play significant roles in this phenomenon. Current evidence suggests this may be so, but mainly in animal studies and small cohorts. The current concept is that vigabatrin affects amino acids by interfering with its metabolic processes, and indirectly affects retinal function.
Participants will be undergoing non-invasive ophthalmological assessments to formally test their visual function, and blood test for identification of plasma biomarkers.This study potentially will provide invaluable information regarding the prognosis of retinal toxicity associated with Vigabatrin over 10 years, with and without prior cessation of Vigabatrin. As there is currently limited knowledge about the prognosis, the results will potentially shed more light on the trajection and pattern of retinal toxicity over time. This information will be vital for patient counselling and will help improve and simplify monitoring methods.
REC name
West of Scotland REC 1
REC reference
15/WS/0234
Date of REC Opinion
23 Nov 2015
REC opinion
Further Information Favourable Opinion