The Leeds Teaching Hospitals NHS Trust


Fingolimod (Gilenya) is a new treatment for highly active relapsing-remitting multiple sclerosis (MS).

Fingolimod is an oral immunomodulator licensed to reduce the frequency of relapses in adult patients with highly active relapsing-remitting MS.  In clinical trials, macular oedema occurred in 0.4% of patients, with or without visual symptoms, at the recommended 0.5 mg dose of fingolimod. The majority of cases occurred within the first 3-4 months of therapy. Some patients presented with blurred vision or decreased visual acuity, but others were asymptomatic and diagnosed on routine ophthalmological examination. An ophthalmological evaluation is therefore recommended for patients 3-4 months after starting treatment. No further routine checks are needed after this time.

Diabetic patients require more regular monitoring.

In clinical studies, macular oedema generally improved or resolved spontaneously after discontinuation of Fingolimod.

There is more information on Fingolimod at the Novartis website

Protocol for screening patients on Fingolimod (Gilenya)

 1.         Referrals received from the prescribing Department

 2.         Appointment with an optometrist arranged within three months of receiving the referral

 3.         The following procedures to be carried out by the optometrist:-

  •  Distance and near visual acuity recorded for each eye
  •  Refraction details recorded
  •  Details of medication recorded including dosage and duration of use
  •  Symptoms of any impaired vision recorded, including distortion, reduced VA, field defect and glare.
  •  Central visual field Amsler chart assessment using a red grid on a black background
  •  Monocular assessment of colour vision using the Ishihara test
  •  Slit lamp examination
  •  Assessment of macular changes using direct ophthalmoscopy/Volk lens assessment with dilation if required
  •  OCT if required

4.         Patients showing any abnormality to be seen in Mr Backhouse's clinic within one month, otherwise no further appointment to be given.

 5.         A letter and copy of the optometrist's report to be sent to the referring consultant from the referring department.