Safety and Efficacy Study of Erythropoietin as add-on Therapy of Methylprednisolone to Treat Acute Optic Neuritis
Double Blind, Placebo-controlled Study to Determine the Safety and Efficacy of Erythropoietin as an add-on Therapy of Methylprednisolone in Subjects With Acute Optic Neuritis (VISION PROTECT)
1 other identifier
interventional
40
1 country
3
Brief Summary
The purpose of this study is to determine the safety and efficacy of erythropoietin as an add-on therapy to methylprednisolone in subjects with acute autoimmune optic neuritis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Aug 2006
Longer than P75 for phase_2
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 20, 2006
CompletedFirst Posted
Study publicly available on registry
July 21, 2006
CompletedStudy Start
First participant enrolled
August 1, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2011
CompletedSeptember 13, 2012
September 1, 2012
4.5 years
July 20, 2006
September 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
nerve fiber loss in the optical nerve head determined by optical coherence tomography at weeks 4,8 and 16 compared to baseline. Measurements at baseline and week 16 are used to calculate estimates for changes and differences between the groups.
4 months
Secondary Outcomes (1)
Visual acuity and visual field perception determined at weeks 1, 4, 8, 16 compared to baseline (week 0). MRI measurements of optic nerve atrophy performed at weeks 4, 8 and 16 compared to baseline (week 0)
4 months
Study Arms (2)
1
ACTIVE COMPARATORerythropoietin
2
NO INTERVENTIONPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- To be eligible to participate in this study, candidates must meet the following eligibility criteria at the time of randomization:
- Must give written informed consent and authorize the release and use of protected health information (PHI).
- Must be 18 to 50 years old, inclusive, at the time of informed consent.
- Must have acute unilateral optic neuritis with or without prior diagnosis of MS (according to McDonald criteria).
- Must have had normal visual acuity on both eyes before and no history of optic neuritis.
- Must have a decreased visual acuity on the affected eye to 0.5 or less at screening.
You may not qualify if:
- Medical history:
- Abnormal laboratory results or clinical signs indicative of any significant cardiac, endocrinologic, hematologic, hepatic, immunologic, metabolic, urologic, pulmonary, gastrointestinal, dermatologic, psychiatric, renal, neurological (other than MS), and/or other major disease.
- History of prior optic neuritis on the affected or non-affected eye.
- History of squint or amblyopia on either side.
- Hyperopia \> 3dptr on either side.
- Myopia \< -5dptr on either side.
- Astigmatism \> 2dptr on either side.
- Horizontal cup disc ratio \> 0.5 on either side.
- Retinal nerve fiber layer thickness outside normal values (with respect to the OCT data base).
- Ocular diseases effecting visual acuity or visual fields (cataract, glaucoma, maculadegeneration, diabetic retinopathy, retinal heredodegeneration or others).
- History of elevated blood pressure.
- Systolic blood pressure of \> 159 mmHg, diastolic blood pressure \> 99 mmHg at screening examination.
- History of thromboembolic events.
- Frequent thromboembolic events in 1st grade family members.
- Significant surgery within the 4 weeks prior to randomization.
- +22 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University Hospital of Hamburg-Eppendorf (Institut of Neuroimmunology and Clinical MS Research (INIMS))
Hamburg, Hamburg, 20246, Germany
Department of Neurology University Hospital Goettingen
Göttingen, Lower Saxony, 37075, Germany
Department of Neurology University Homborg Hospital of the Saarland, Germany
Homburg, Saarland, 66421, Germany
Related Publications (3)
Maier K, Rau CR, Storch MK, Sattler MB, Demmer I, Weissert R, Taheri N, Kuhnert AV, Bahr M, Diem R. Ciliary neurotrophic factor protects retinal ganglion cells from secondary cell death during acute autoimmune optic neuritis in rats. Brain Pathol. 2004 Oct;14(4):378-87. doi: 10.1111/j.1750-3639.2004.tb00081.x.
PMID: 15605985BACKGROUNDSuhs KW, Papanagiotou P, Hein K, Pul R, Scholz K, Heesen C, Diem R. Disease Activity and Conversion into Multiple Sclerosis after Optic Neuritis Is Treated with Erythropoietin. Int J Mol Sci. 2016 Sep 30;17(10):1666. doi: 10.3390/ijms17101666.
PMID: 27706045DERIVEDSuhs 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.
PMID: 22926853DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ricarda Diem, MD Prof.
Department of Neurology University Homborg Hospital of the Saarland, Germany
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
July 20, 2006
First Posted
July 21, 2006
Study Start
August 1, 2006
Primary Completion
February 1, 2011
Study Completion
July 1, 2011
Last Updated
September 13, 2012
Record last verified: 2012-09