Background: Fingolimod (FNG) is associated with the development of symptomatic macular edema (ME) in a small subset of multiple sclerosis (MS) patients. By using spectral domain optical coherence tomography (SD-OCT), an increase in the total macular volume (TMV) was rarely detected during the first months of treatment.
Objectives: The objective of this study is to assess whether FNG treatment leads to long-term macular changes in a real-life setting.
Methods: Sixty RRMS patients starting FNG, according to therapeutic indication, were enrolled at three Italian MS centers and followed for 2 years.
Results: The mean TMV did not change between baseline and the follow-up. No patients experienced visual acuity drop during the follow-up.
Conclusions: Initiation of FNG in MS is associated with a modest, not significant, increase in macular volume followed by no further significant changes over 2 years, highlighting the good safety profile of such treatment in MS.
Keywords: Fingolimod; Macular volume; Multiple sclerosis; Optical coherence tomography; Safety.