Ophthalmic Evaluations in Clinical Studies of Fingolimod (FTY720) in Multiple Sclerosis – Corrected Proof
Purpose:
To report outcomes of ophthalmic evaluations in clinical studies of patients receiving fingolimod (Gilenya; Novartis Pharma AG, Basel, Switzerland) for multiple sclerosis (MS).
Design:
Analysis done on pooled safety data (N = 2615, all studies group) from 3 double-masked, randomized, parallel-group clinical trials (phase 2 core and extension >5 years, and phase 3 FREEDOMS and TRANSFORMS core and extension studies).
Participants:
Patients aged 18 to 55 years (18–60 years in phase 2 study) diagnosed with relapsing-remitting MS were included. Patients with diabetes mellitus or macular edema (ME) at screening were excluded.
Intervention:
Participants received fingolimod (0.5/1.25 mg), placebo, or (Read more...)