Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
Information source: University Eye Hospital, Freiburg
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Optic Neuritis
Intervention: Erythropoietin alfa (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
Sponsored by: University Eye Hospital, Freiburg Official(s) and/or principal investigator(s): Wolf A. Lagrèze, Prof., Principal Investigator, Affiliation: Eye Hospital, Medical Center - University of Freiburg
Overall contact: Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de
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.
Clinical Details
Official title: Treatment of Optic Neuritis With Erythropoietin: a Randomised, Double-blind, Placebo-controlled Trial
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Global retinal nerve fibre layer thickness (RNFLT-G)Low contrast visual acuity (LCVA)
Secondary outcome: Absolute values of the global retinal nerve fibre layer thicknessRetinal nerve fibre layer thickness in the papillomacular bundle Retinal nerve fibre layer thickness in the temporal quadrant Total macular volume Visual acuity Contrast sensitivity Mean visual field defect Latency [ms] and amplitude [µV] of visual evoked potentials (VEP) Expanded Disability Status Scale (EDSS) score Quality of life Safety
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de
Charité Berlin, Berlin 10117, Germany; Recruiting
University Medical Center Hamburg-Eppendorf, Hamburg 20246, Germany; Recruiting Christoph Heesen, Prof. Dr.
Medical Center - University of Freiburg, Eye Hospital, Freiburg, Baden-Wuerttemberg 79106, Germany; Recruiting Wolf A. Lagrèze, Prof., Phone: +49 761 270, Ext: 40010, Email: wolf.lagreze@uniklinik-freiburg.de
Heidelberg University Hospital, Department of Neurooncology, Heidelberg, Baden-Wuerttemberg 69120, Germany; Recruiting Ricarda Diem, Prof., Phone: +49 6221 56, Ext: 37774, Email: ricarda.diem@med.uni-heidelberg.de
Tuebingen University Hospital, Tuebingen, Baden-Wuerttemberg 72076, Germany; Recruiting
University Hospital Erlangen, Erlangen, Bayern 91054, Germany; Recruiting
University Hospital Klinikum rechts der Isar, Munich, Munich, Bayern 81675, Germany; Recruiting
University Hospital of Munich, Munich, Bayern 81377, Germany; Recruiting
University Medical Center Goettingen, Goettingen, Niedersachen 37075, Germany; Recruiting
Hannover Medical School, Hannover, Niedersachsen 30625, Germany; Recruiting
Duesseldorf University Hospital, Duesseldorf, Nordrhein-Westfalen 40225, Germany; Recruiting
Essen University Hospital, Essen, Nordrhein-Westfalen 45122, Germany; Recruiting
University Medical Center of the Johannes Gutenberg University Mainz, Mainz, Rheinland-Pfalz 55131, Germany; Recruiting
Additional Information
Study information and useful links in German language
Related publications: 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.
Starting date: November 2014
Last updated: June 9, 2015
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