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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01962571
Other study ID # P000053
Secondary ID 2013-002515-10DR
Status Completed
Phase Phase 3
First received
Last updated
Start date November 25, 2014
Est. completion date November 26, 2019

Study information

Verified date November 2019
Source University Eye Hospital, Freiburg
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 108
Est. completion date November 26, 2019
Est. primary completion date June 20, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years to 50 Years
Eligibility Patients eligible for inclusion in this trial must meet all of the following criteria:

1. Written informed consent obtained according to international guidelines and local laws

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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Erythropoietin alfa

Placebo


Locations

Country Name City State
Germany Duesseldorf University Hospital Duesseldorf Nordrhein-Westfalen
Germany University Hospital Erlangen Erlangen Bayern
Germany Medical Center - University of Freiburg, Eye Hospital Freiburg Baden-Wuerttemberg
Germany University Medical Center Göttingen Göttingen Niedersachsen
Germany University Medical Center Hamburg-Eppendorf Hamburg
Germany Hannover Medical School Hannover Niedersachsen
Germany Heidelberg University Hospital, Department of Neurooncology Heidelberg Baden-Wuerttemberg
Germany University Medical Center of the Johannes Gutenberg University Mainz Mainz Rheinland-Pfalz
Germany University Hospital Klinikum rechts der Isar, Munich Munich Bayern
Germany University Hospital of Munich Munich Bayern
Germany Tuebingen University Hospital Tuebingen Baden-Wuerttemberg

Sponsors (2)

Lead Sponsor Collaborator
University Eye Hospital, Freiburg German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Diem R, Molnar F, Beisse F, Gross N, Drüschler K, Heinrich SP, Joachimsen L, Rauer S, Pielen A, Sühs KW, Linker RA, Huchzermeyer C, Albrecht P, Hassenstein A, Aktas O, Guthoff T, Tonagel F, Kernstock C, Hartmann K, Kümpfel T, Hein K, van Oterendorp C, Grotejohann B, Ihorst G, Maurer J, Müller M, Volkmann M, Wildemann B, Platten M, Wick W, Heesen C, Schiefer U, Wolf S, Lagrèze 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. — View Citation

Sühs KW, Hein K, Sättler MB, Görlitz A, Ciupka C, Scholz K, Käsmann-Kellner B, Papanagiotou P, Schäffler N, Restemeyer C, Bittersohl D, Hassenstein A, Seitz B, Reith W, Fassbender K, Hilgers R, Heesen C, Bähr 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Global retinal nerve fibre layer thickness (RNFLT-G) Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of global retinal nerve fibre layer thickness (RNFLT-G) in the affected eye 6 months after randomisation. 6 months
Primary Low contrast visual acuity (LCVA) Determination of the efficacy of erythropoietin compared to placebo given as add-on to methylprednisolone (standard of care) as assessed by measurement of low contrast visual acuity (LCVA) in the affected eye 6 months after randomisation. 6 months
Secondary Absolute values of the global retinal nerve fibre layer thickness 6 months
Secondary Retinal nerve fibre layer thickness in the papillomacular bundle 6 months
Secondary Retinal nerve fibre layer thickness in the temporal quadrant 6 months
Secondary Total macular volume 6 months
Secondary Visual acuity 6 months
Secondary Contrast sensitivity 6 months
Secondary Mean visual field defect 6 months
Secondary Latency [ms] and amplitude [µV] of visual evoked potentials (VEP) 6 months
Secondary Expanded Disability Status Scale (EDSS) score 6 months
Secondary Quality of life Determined by NEI-VFQ-25 6 months
Secondary Safety Assessment of AEs / SAEs Screening until end of study
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