Evidence mapPaperPMID 26932144Full record

Trial reportBMJ open2016

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

Ricarda Diem, Fanni Molnar, Flemming Beisse, Nikolai Gross, Katharina Drüschler, Sven P Heinrich, Lutz Joachimsen, Sebastian Rauer, Amelie Pielen, Kurt-Wolfram Sühs and 24 more

Registry-linked trialOpen access · goldAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01962571 (Treatment of Optic Neuritis With Erythropoietin), which is not on this map. Cited by 21 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
21citing papers in PubMed, 1 pooled it
6.6field-weighted citation impact, top 3% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01962571 phase3completednot on this map

Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial

TypeinterventionalSponsorUniversity Eye Hospital, FreiburgRan2014 to 2019Enrolled108ConditionsOptic NeuritisArmsErythropoietin alfa, Placebo
3 · Its place in the literature

Who cites it

21 citing papers in PubMed, 1 synthesis or guideline pooled it, 50 citations in OpenAlex.

  1. Therapeutic role of erythropoietin in methanol induced optic neuropathy: a systematic review.Daru : journal of Faculty of Pharmacy, Tehran University of Medical Sciences · 2024
    Pooled it
  2. Article
  3. Treatment With Erythropoietin for Patients With Optic Neuritis: Long-term Follow-up.Neurology(R) neuroimmunology & neuroinflammation · 2023
    Article
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  5. Review
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  13. Observational
  14. How to pursue EPO in MS.Multiple sclerosis (Houndmills, Basingstoke, England) · 2018
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

34 authors at 15 institutions in 3 countries.

Ricarda DiemDepartment of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Fanni MolnarEye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Flemming BeisseDepartment of Ophthalmology, Heidelberg University Hospital, Heidelberg, Germany.
Nikolai GrossEye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Katharina DrüschlerDepartment of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Sven P HeinrichEye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Lutz JoachimsenEye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Sebastian RauerDepartment of Neurology and Neuroscience, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Amelie PielenClinic for Ophthalmology, Hannover Medical School, Hannover, Germany.
Kurt-Wolfram SühsClinic for Neurology, Hannover Medical School, Hannover, Germany.
Ralf Andreas LinkerDepartment of Neurology, University Hospital Erlangen, Erlangen, Germany.
Cord HuchzermeyerDepartment of Ophthalmology, University Hospital Erlangen, Erlangen, Germany.
Philipp AlbrechtDepartment of Neurology, Medical faculty, Heinrich Heine University, Düsseldorf, Germany.
Andrea HassensteinDepartment of Ophthalmology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Orhan AktasDepartment of Neurology, Medical faculty, Heinrich Heine University, Düsseldorf, Germany.
Tanja GuthoffDepartment of Ophthalmology, Medical Faculty, Heinrich Heine University, Düsseldorf, Germany.
Felix TonagelUniversity Eye Hospital Tübingen, Tübingen, Germany.
Christoph KernstockUniversity Eye Hospital Tübingen, Tübingen, Germany.
Kathrin HartmannDepartment of Ophthalmology, University Hospital Munich LMU, Munich, Germany.
Tania KümpfelDepartment of Neurology, University Hospital Munich, Munich, Germany.
Katharina HeinDepartment of Neurology, University Medical Center Göttingen, Göttingen, Germany.
Christian van OterendorpDepartment of Ophthalmology, University Medical Center Göttingen, Göttingen, Germany.
Birgit GrotejohannClinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Gabriele IhorstClinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Julia MaurerClinical Trials Unit, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Matthias MüllerCompetence Center "Vision Research", Study Course Ophthalmological Optics, Faculty of Optics and Mechatronics, University of Applied Sciences, Aalen, Germany.
Martin VolkmannMedical Service Center PD Dr. Volkmann and Colleges, Karlsruhe, Germany.
Brigitte WildemannDepartment of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Michael PlattenDepartment of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Wolfgang WickDepartment of Neurology, Heidelberg University Hospital, Heidelberg, Germany.
Christoph HeesenDepartment of Neurology, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
Ulrich SchieferUniversity Eye Hospital Tübingen, Tübingen, Germany Competence Center "Vision Research", Study Course Ophthalmological Optics, Faculty of Optics and Mechatronics, University of Applied Sciences, Aalen, Germany Center for Ophthalmology, Institute for Ophthalmic Research, University of Tübingen, Tübingen, Germany.
Sebastian WolfDepartment of Ophthalmology, Bern Photographic Reading Center, University Hospital and University of Bern, Bern, Switzerland.
Wolf A LagrèzeEye Center, Medical Center-University of Freiburg, Freiburg im Breisgau, Germany.
Heidelberg University · DEUniversity of Freiburg · DEUniversity Medical Center Freiburg · DEHeinrich Heine University Düsseldorf · DEMedizinische Hochschule Hannover · DESTZ eyetrial · DEUniversitätsklinikum Erlangen · DEUniversitätsmedizin Göttingen · DEUniversity Medical Center Hamburg-Eppendorf · DEHochschule Aalen · DELudwig-Maximilians-Universität München · DEMünchen Klinik · DEUniversity Hospital Heidelberg · DEUniversity of Bern · CHUniversity of Tübingen · DE

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

introductionOptic neuritis leads to degeneration of retinal ganglion cells whose axons form the optic nerve. The standard treatment is a methylprednisolone pulse therapy. This treatment slightly shortens the time of recovery but does not prevent neurodegeneration and persistent visual impairment. In a phase II trial performed in preparation of this study, we have shown that erythropoietin protects global retinal nerve fibre layer thickness (RNFLT-G) in acute optic neuritis; however, the preparatory trial was not powered to show effects on visual function. 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.

Indexed as

Clinical ProtocolsVisual AcuityAdolescentAdultDouble-Blind MethodErythropoietinFemaleGermanyHumansLinear ModelsMaleMiddle AgedOptic NeuritisProportional Hazards ModelsRetinaTreatment OutcomeErythropoietinErythropoietinLow Contrast Visual AcuityNeuroprotectionOptical coherence tomographyOptic neuritis

Identifiers

PMID26932144
PMCPMC4785322
OpenAlexW2291129465

What Socratic holds

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LicenceCC BY-NC
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the Socratic graph.