Fingolimod in optic neuritis (ADON)
Research type
Research Study
Full title
A 48 week, double-blind, randomized, multi-center, parallel-group study comparing structural changes in the retina and evolution of visual function after immediate versus delayed treatment with fingolimod in patients with acute demyelinating optic neuritis
IRAS ID
126104
Contact name
James Warburton
Contact email
Sponsor organisation
Novartis Pharmaceuticals UK Ltd
Eudract number
2012-002968-27
Clinicaltrials.gov Identifier
Research summary
Acute demyelinating optic neuritis (ADON) is swelling (inflammation) of the optic nerve in the eye, which causes blurring, graying or loss of vision, often with accompanying pain.
At present, ADON is treated with steroids which improve some measurements of eye function in these patients but there is currently no treatment to stop loss of vision.
Fingolimod (FTY720) has already been approved to treat people with multiple sclerosis, and it may prevent vision loss in patients with ADON. It is taken once daily as a tablet. Fingolimod acts on the white bloods cells responsible for immune reactions and prevents them from moving to the site of inflammation. The white blood cells instead remain in the lymph nodes and other places where they normally rest. These cells are believed to play an important role in the inflammation process which causes ADON.
The main purpose of this study is to see if fingolimod affects vision and how safe and well tolerated it is in patients with ADON. Half the patients joining the study will receive fingolimod and half will receive a dummy (placebo) pill for the first 18 weeks, then everyone will receive fingolimod for the next 30 weeks of the study.
Each patient who gives consent and meets the study entry criteria will visit the hospital clinic every 1 to 3 months (a total of 10 times) over a 60 week period for assessments, including vision tests, eye examinations, brain scans using Magnetic Resonance Imaging (MRI) to detect any swelling, optical coherence tomography (OCT) to measure thickness of the retina in the eye, blood tests, heart rate measurements using an ECG (electrocardiogram) and completion of health and vision-related questionnaires.
Approximately 126 patients will be treated at around 60 centres worldwide, of which around 18 patients will be included from approximately 6 sites in the UK.
REC name
London - London Bridge Research Ethics Committee
REC reference
13/LO/0542
Date of REC Opinion
29 May 2013
REC opinion
Further Information Favourable Opinion