Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
NCT ID: NCT01962571
Last Updated: 2019-12-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
108 participants
INTERVENTIONAL
2014-11-25
2019-11-26
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Erythropoietin alfa
Recombinant human EPO (Epoetin alfa HEXAL®) will be given as an i.v. bolus injection on days 1, 2 and 3. The dosage per day will be 33.000 IU in accordance with previous trials.
Erythropoietin alfa
Placebo
As matched placebo for this study, sterile normal saline (0.9% sodium chloride for i.v. administration) will be used. It will be given as a bolus injection in the same manner as EPO.
Placebo
Interventions
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Erythropoietin alfa
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male and female patients aged ≥ 18 to ≤ 50 years
3. Patients with ON
4. First symptoms of ON ≤ 10 days prior to the first administration of investigational product
5. High contrast visual acuity (HCVA) of ≤ 0.5 (decimal system)
6. Adequate OCT measurements available
Patients eligible for this trial must not meet any of the following criteria:
1. Patient without legal capacity who is unable to understand the nature, significance and consequences of the trial
2. Simultaneous participation in another interventional trial which could interfere with this trial and/or participation in a clinical trial within the last 3 months before enrolment in this trial
3. Refractive anomalies: Hyperopia \> 5 dpt, myopia \< -7 dpt, astigmatism \> 3 dpt
4. Media opacity
5. Severe papillitis
6. Previous ON
7. Any other optic nerve and retinal disease
8. Pre-existing MS or any other neurological disease
9. Congenital diseases:
* thrombophilia
* phenylketonuria
10. Acquired diseases:
* autoimmune diseases,
* cardiovascular diseases,
* diabetes mellitus,
* uncontrolled hypertension (with blood pressure \> 140 / 90 mm Hg (cf. chapter 7.7.5)),
* any malignancy,
* epilepsy,
* known tuberculosis with ongoing or unknown activity,
* acute gastrointestinal ulceration within the last 3 months prior to randomisation,
* acute viral, bacterial or fungal infection,
* known infection with Human Immunodeficiency Virus (HIV), Hepatitis B Virus, or Hepatitis C Virus,
* history of colitis ulcerosa, diverticulitis, or acute enteroanastomosis,
* known osteoporosis,
* history of thromboembolic events,
* elevated haemoglobin level (\>17 g/dl in men or \>15 g/dl in women)
* polycythaemia
* any other significant illness potentially interfering with any trial assessment or trial treatment
11. Performing semi-professional or professional sporting activities or physical training
12. Pre-treatment with corticosteroids in the last 30 days prior to the onset of optic neuritis
13. Pre-treatment with EPO
14. Known or persistent abuse of medication, drugs or alcohol
15. Active immunization within 2 weeks prior to randomisation
16. Significant surgery within 4 weeks prior to randomisation
17. Blood donation or bloodletting within 4 weeks prior to screening
18. Pre-treatment with immunosuppressive or immunomodulatory agents
19. Persons who are in a relationship of dependence/employment with the sponsor or the investigator
This section concerns only female patients who are able to have a child:
20. Current or planned pregnancy; nursing period within 3 months from investigational product administration
21. Unwillingness to use one of the following safe combination methods of contraception within 3 months from investigational product administration to achieve a PEARL index of \<1: female condom, diaphragm or coil, each used in combination with a spermicide; hormonal intra-uterine device or hormonal contraception in combination with a mechanical method of contraception
18 Years
50 Years
ALL
No
Sponsors
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German Federal Ministry of Education and Research
OTHER_GOV
University Eye Hospital, Freiburg
OTHER
Responsible Party
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Prof. Dr. Wolf Lagrèze
Prof. Dr. med.
Principal Investigators
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Wolf A. Lagrèze, Prof.
Role: PRINCIPAL_INVESTIGATOR
Eye Hospital, Medical Center - University of Freiburg
Locations
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Medical Center - University of Freiburg, Eye Hospital
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Heidelberg University Hospital, Department of Neurooncology
Heidelberg, Baden-Wurttemberg, Germany
Tuebingen University Hospital
Tübingen, Baden-Wurttemberg, Germany
University Hospital Erlangen
Erlangen, Bavaria, Germany
University Hospital of Munich
Munich, Bavaria, Germany
University Hospital Klinikum rechts der Isar, Munich
Munich, Bavaria, Germany
University Medical Center Göttingen
Göttingen, Lower Saxony, Germany
Hannover Medical School
Hanover, Lower Saxony, Germany
Duesseldorf University Hospital
Düsseldorf, North Rhine-Westphalia, Germany
University Medical Center of the Johannes Gutenberg University Mainz
Mainz, Rhineland-Palatinate, Germany
University Medical Center Hamburg-Eppendorf
Hamburg, , Germany
Countries
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References
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Suhs KW, Hein K, Sattler MB, Gorlitz A, Ciupka C, Scholz K, Kasmann-Kellner B, Papanagiotou P, Schaffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bahr M, Diem R. A randomized, double-blind, phase 2 study of erythropoietin in optic neuritis. Ann Neurol. 2012 Aug;72(2):199-210. doi: 10.1002/ana.23573.
Diem R, Molnar F, Beisse F, Gross N, Druschler K, Heinrich SP, Joachimsen L, Rauer S, Pielen A, Suhs KW, Linker RA, Huchzermeyer C, Albrecht P, Hassenstein A, Aktas O, Guthoff T, Tonagel F, Kernstock C, Hartmann K, Kumpfel T, Hein K, van Oterendorp C, Grotejohann B, Ihorst G, Maurer J, Muller M, Volkmann M, Wildemann B, Platten M, Wick W, Heesen C, Schiefer U, Wolf S, Lagreze WA. Treatment of optic neuritis with erythropoietin (TONE): a randomised, double-blind, placebo-controlled trial-study protocol. BMJ Open. 2016 Mar 1;6(3):e010956. doi: 10.1136/bmjopen-2015-010956.
Kuchlin S, Ihorst G, Heinrich SP, Farassat N, Marquez Neila P, Hug MJ, Albrecht P, Lagreze WA. Clinical Predictors in Acute Optic Neuritis: Analysis Based on Clinical Trial Data. Ophthalmology. 2025 Jun;132(6):631-643. doi: 10.1016/j.ophtha.2025.01.010. Epub 2025 Jan 17.
Kuchlin S, Ihorst G, Heinrich SP, Marquez Neila P, Albrecht P, Hug MJ, Diem R, Lagreze WA. Disease Course of Clinically Isolated Optic Neuritis. Neurol Neuroimmunol Neuroinflamm. 2024 May;11(3):e200223. doi: 10.1212/NXI.0000000000200223. Epub 2024 Apr 8.
Kuchlin S, Ihorst G, Grotejohann B, Beisse F, Heinrich SP, Albrecht P, Ungewiss J, Worner M, Hug MJ, Wolf S, Diem R, Lagreze WA; TONE Study Group. Treatment With Erythropoietin for Patients With Optic Neuritis: Long-term Follow-up. Neurol Neuroimmunol Neuroinflamm. 2023 Apr 24;10(4):e200067. doi: 10.1212/NXI.0000000000200067. Print 2023 Jul.
Lagreze WA, Kuchlin S, Ihorst G, Grotejohann B, Beisse F, Volkmann M, Heinrich SP, Albrecht P, Ungewiss J, Worner M, Hug MJ, Wolf S, Diem R; TONE study group. Safety and efficacy of erythropoietin for the treatment of patients with optic neuritis (TONE): a randomised, double-blind, multicentre, placebo-controlled study. Lancet Neurol. 2021 Dec;20(12):991-1000. doi: 10.1016/S1474-4422(21)00322-7.
Wilhelm H, Schabet M. The Diagnosis and Treatment of Optic Neuritis. Dtsch Arztebl Int. 2015 Sep 11;112(37):616-25; quiz 626. doi: 10.3238/arztebl.2015.0616.
Lagreze W, Diem R. [New aspects in the therapy of multiple sclerosis and optic neuritis]. Ophthalmologe. 2014 Aug;111(8):709-14. doi: 10.1007/s00347-013-2987-7. German.
Other Identifiers
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2013-002515-10
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
DRKS00005298
Identifier Type: REGISTRY
Identifier Source: secondary_id
01KG1306
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
P000053
Identifier Type: -
Identifier Source: org_study_id
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