NCT01962571: TONE

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

Completed Phase 3 Last updated 2 December 2019

What this trial tests

Phase 3 trial testing Erythropoietin alfa in Optic Neuritis in 108 participants. Completed in 26 November 2019.

Timeline

25 November 2014

Primary endpoint
20 June 2018

26 November 2019

Quick facts

Lead sponsor	University Eye Hospital, Freiburg
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	108
Start date	25 November 2014
Primary completion	20 June 2018
Estimated completion	26 November 2019
Sites	11 locations across Germany

Drugs / interventions tested

• Erythropoietin alfa — full drug profile →
• Placebo

Conditions studied

• Optic Neuritis — all drugs for Optic Neuritis →

Sponsor

University Eye Hospital, Freiburg

Who can join

Adults 18 to 50, any sex, with Optic Neuritis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims at preventing visual dysfunction and optic nerve degeneration associated with autoimmune optic neuritis by systemic i.v. administration of 33.000 IU erythropoietin over 3 days. The primary objective is to determine the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone as assessed by measurements of retinal nerve fibre layer thickness and low contrast visual acuity 6 months after acute optic neuritis.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. The Diagnosis and Treatment of Optic Neuritis.
   Wilhelm H, Schabet M. · · 2015 · cited 71× · PMID 26396053 · DOI 10.3238/arztebl.2015.0616
2. Neuro-protection and neuro-regeneration of the optic nerve: recent advances and future directions.
   Gokoffski KK, Peng M, Alas B, Lam P. · · 2020 · cited 45× · PMID 31809331 · DOI 10.1097/wco.0000000000000777
3. Revisiting the role of erythropoietin for treatment of ocular disorders.
   Shirley Ding SL, Leow SN, Munisvaradass R, Koh EH, et al · · 2016 · cited 41× · PMID 27285322 · DOI 10.1038/eye.2016.94
4. The changing landscape of optic neuritis: a narrative review.
   De Lott LB, Bennett JL, Costello F. · · 2022 · cited 40× · PMID 33389032 · DOI 10.1007/s00415-020-10352-1
5. Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial-study protocol.
   Diem R, Molnar F, Beisse F, Gross N, et al · · 2016 · cited 38× · PMID 26932144 · DOI 10.1136/bmjopen-2015-010956
6. Safety and efficacy of erythropoietin for the treatment of patients with optic neuritis (TONE): a randomised, double-blind, multicentre, placebo-controlled study.
   Lagrèze WA, Küchlin S, Ihorst G, Grotejohann B, et al · · 2021 · cited 21× · PMID 34800417 · DOI 10.1016/s1474-4422(21)00322-7
7. Treatment With Erythropoietin for Patients With Optic Neuritis: Long-term Follow-up.
   Küchlin S, Ihorst G, Grotejohann B, Beisse F, et al · · 2023 · cited 8× · PMID 37094997 · DOI 10.1212/nxi.0000000000200067
8. Disease Activity and Conversion into Multiple Sclerosis after Optic Neuritis Is Treated with Erythropoietin.
   Sühs KW, Papanagiotou P, Hein K, Pul R, et al · · 2016 · cited 6× · PMID 27706045 · DOI 10.3390/ijms17101666