Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial-study protocol.
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Diem Ricarda, Molnar Fanni, Beisse Flemming, Gross Nikolai, Drüschler Katharina, Heinrich Sven P, Joachimsen Lutz, Rauer Sebastian, Pielen Amelie, Sühs Kurt-Wolfram, Linker Ralf Andreas, Huchzermeyer Cord, Albrecht Philipp, Hassenstein Andrea, Aktas Orhan, Guthoff Tanja, Tonagel Felix, Kernstock Christoph, Hartmann Kathrin, Kümpfel Tania, Hein Katharina, van Oterendorp Christian, Grotejohann Birgit, Ihorst Gabriele, Maurer Julia, Müller Matthias, Volkmann Martin, Wildemann Brigitte, Platten Michael, Wick Wolfgang, Heesen Christoph, Schiefer Ulrich, Wolf Sebastian, Lagrèze Wolf A
Аннотация
METHODS AND ANALYSIS: Treatment of Optic Neuritis with Erythropoietin (TONE) is a national, randomised, double-blind, placebo-controlled, multicentre trial with two parallel arms. The primary objective is to determine the efficacy of erythropoietin compared to placebo given add-on to methylprednisolone as assessed by measurements of RNFLT-G and low-contrast visual acuity in the affected eye 6 months after randomisation. Inclusion criteria are a first episode of optic neuritis with decreased visual acuity to ≤ 0.5 (decimal system) and an onset of symptoms within 10 days prior to inclusion. The most important exclusion criteria are history of optic neuritis or multiple sclerosis or any ocular disease (affected or non-affected eye), significant hyperopia, myopia or astigmatism, elevated blood pressure, thrombotic events or malignancy. After randomisation, patients either receive 33,000 international units human recombinant erythropoietin intravenously for 3 consecutive days or placebo (0.9% saline) administered intravenously. With an estimated power of 80%, the calculated sample size is 100 patients. The trial started in September 2014 with a planned recruitment period of 30 months.
ETHICS AND DISSEMINATION: TONE has been approved by the Central Ethics Commission in Freiburg (194/14) and the German Federal Institute for Drugs and Medical Devices (61-3910-4039831). It complies with the Declaration of Helsinki, local laws and ICH-GCP.
TRIAL REGISTRATION NUMBER: NCT01962571.