Evidence map›Paper›PMID 38588480›Full record

Trial reportNeurology(R) neuroimmunology & neuroinflammation2024

Disease Course of Clinically Isolated Optic Neuritis.

Sebastian Küchlin, Gabriele Ihorst, Sven P Heinrich, Pablo Márquez Neila, Philipp Albrecht, Martin J Hug, Ricarda Diem, Wolf A Lagrèze

Registry-linked trialOpen access · goldAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Neurology(R) neuroimmunology & neuroinflammation, 2024. 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 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
1.3field-weighted citation impact, top 22% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Ten Years ofNeurology(R) neuroimmunology & neuroinflammation · 2025
    Article
  3. Article
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

8 authors at 1 institution in 3 countries.

Sebastian KüchlinFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.ORCID 0000-0003-0758-5120
Gabriele IhorstFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.ORCID 0000-0002-8091-1589
Sven P HeinrichFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.ORCID 0000-0003-4906-3937
Pablo Márquez NeilaFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.
Philipp AlbrechtFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.ORCID 0000-0001-7987-658X
Martin J HugFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.
Ricarda DiemFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.
Wolf A LagrèzeFrom the Eye Center (S.K., S.P.H., W.A.L.); Clinical Trials Unit (G.I.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg, Germany; ARTOG (P.M.N.), University of Bern, Switzerland; Department of Neurology (P.A.), Maria Hilf Clinics Mönchengladbach; Department of Neurology (P.A.), Medical Faculty, Heinrich Heine-Universität Düsseldorf; Pharmacy (M.J.H.), Medical Center - University of Freiburg, Faculty of Medicine, University of Freiburg; and Department of Neurology and National Center for Tumor Diseases (R.D.), Faculty of Medicine, University Hospital Heidelberg, Germany.
University of Bern · CH

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND AND

objectivesOptic neuritis is the most common optic neuropathy in young adults and a frequent manifestation of multiple sclerosis. Its clinical course is pertinent to the design of visual pathway neuroprotection trials.

methodsThis is a secondary analysis of longitudinal data from the TONE trial, which included 103 patients from 12 German academic tertiary centers with acute unilateral optic neuritis as a clinically isolated syndrome and baseline high-contrast visual acuity <0.5 decimal. Patients were randomized to 1,000 mg methylprednisolone i.v./d plus either erythropoietin (33,000 IU/d) or placebo (saline solution) for 3 days. They were followed up at standardized intervals with a battery of tests including high-contrast visual acuity, low-contrast letter acuity, contrast sensitivity, visual fields, visual evoked potentials, and retinal optical coherence tomography. At 6 months, participants answered a standardized questionnaire on vision-related quality of life (NEI-VFQ 25). We describe the disease course with mixed-effects piecewise linear models and calculate structure-function correlations using Pearson r. Because erythropoietin had no effect on the visual system, we use pooled (treatment-agnostic) data.

resultsPatients experienced initial rapid and then decelerating improvements of visual function with thinning of inner and thickening of outer retinal layers. At 6 months, visual parameters were positively correlated with inner and negatively correlated with outer retinal thickness changes. Peripapillary retinal nerve fiber layer thinning predominantly occurred in sectors without previous swelling. At 6 months, macular ganglion cell and inner plexiform layer thinning was weakly correlated with the P100 peak time (r = -0.11) and moderately correlated with the amplitude of visual evoked potentials (r = 0.35). Only functional outcomes were at least moderately correlated with vision-related quality of life. DISCUSSION: The longitudinal data from this large study cohort may serve as a reference for the clinical course of acute optic neuritis. The pattern of correlation between visual evoked potentials and inner retinal thinning may argue that the latter is mostly due to ganglion cell loss, rather than dysfunction. Visual pathway neuroprotection trials with functional outcomes are needed to confirm that candidate drugs will benefit patients' vision-related quality of life. TRIAL REGISTRATION INFORMATION: ClinicalTrials.gov, NCT01962571.

Indexed as

ErythropoietinOptic NeuritisDisease ProgressionEvoked Potentials, VisualHumansQuality of LifeYoung AdultErythropoietin

Identifiers

PMID38588480
PMCPMC11010245
OpenAlexW4394589732

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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 OpenQuestion graph.