Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial—study protocol

摘要: Introduction Optic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This slightly shortens time recovery but does not prevent neurodegeneration and persistent visual impairment. In phase II trial performed in preparation this study, we have shown that erythropoietin protects global nerve fibre layer thickness (RNFLT-G) acute neuritis; however, preparatory was powered show effects on function. Methods analysis Treatment Neuritis with Erythropoietin (TONE) national, randomised, double-blind, placebo-controlled, multicentre two parallel arms. primary objective determine efficacy compared placebo given add-on as assessed by measurements RNFLT-G low-contrast acuity affected eye 6 months after randomisation. Inclusion criteria are first episode decreased ≤0.5 (decimal system) an onset symptoms within 10 days prior inclusion. most important exclusion history or multiple sclerosis any ocular disease (affected non-affected eye), significant hyperopia, myopia astigmatism, elevated blood pressure, thrombotic events malignancy. After randomisation, patients either receive 33 000 international units human recombinant intravenously for 3 consecutive days (0.9% saline) administered intravenously. With estimated power 80%, calculated sample size 100 patients. started September 2014 planned recruitment period 30 months. Ethics dissemination TONE has been approved Central Commission Freiburg (194/14) German Federal Institute Drugs Medical Devices (61-3910-4039831). It complies Declaration Helsinki, local laws ICH-GCP. Trial registration number NCT01962571.