Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.

Study Overview
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Brief Summary
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The goal of this double-blind prospective randomized clinical trial is to determine if the effect of intravenous erythropoietin is superior to the effect of intravenous methylprednisolone in cases of toxic optic neuropathy 4 weeks after therapeutic intervention. The main question it aims to answer: • Is there a difference in the visual recovery of toxic optic neuropathies treated with intravenous methylprednisolone in comparison with those treated with intravenous erythropoietin?

Detailed Description
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A double-blind prospective randomized clinical trial of treatment for toxic optic neuropathies comparing visual outcome of patients treated by standard treatment (intravenous methylprednisolone) vs intravenous erythropoietin. Enrollment: 18. Randomized groups (2) Standard treatment (intravenous methylprednisolone) Intravenous erythropoietin Masking: Double (participant and outcomes assessor) Participants won't be aware to which group they were assigned. Investigator in charge of assessing outcomes and analyzing data won't be aware to which group participants were assigned

Official Title
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Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.

Conditions
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Toxic Optic Neuropathy, Treatment, Methylprednisolone, Erythropoietin

Intervention / Treatment
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* Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI
* Drug: Methylprednisolone succinate 500 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Both genres. Age between 18 and 75 years. Clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquired dyschromatopsia, visual loss and bilateral prechiasmatic field defect). Exposure with a temporal relationship of less than two weeks to a known toxicant for the function of the optic nerve. Up to 21 days from symptom onset. Informed consent signature. Exclusion Criteria: History of previous optic neuropathy. History of additional ophthalmological or neurological pathology that has caused permanent visual loss. History of previous treatment with intravenous methylprednisolone or some other experimental treatment since the onset of symptoms. Poorly controlled diabetes mellitus. Poorly controlled systemic arterial hypertension. Hemoglobin >16 mg/dL Patients with a history of thromboembolic event. Patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event. Pregnancy or lactation.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized groups (2) Standard treatment (Intravenous methylprednisolone) Intervention (Intravenous erythropoietin)
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days. | Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI<br>* Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)<br>* Other names: Experimental Group;|
| Placebo Comparator: Control group<br>The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days. | Drug: Methylprednisolone succinate 500 mg<br>* Intravenous Methylprednisolone succinate (1 g daily for 5 days)<br>* Other names: Control Group;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Visual Capacity | Best corrected visual acuity | Initial visit, 2-week visit, 1-month visit, 3-month visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Color vision | Color vision as measured by Ishihara plates | Initial visit, 2-week visit, 1-month visit, 3-month visit | 
| Change from Baseline Visual field defect | Visual fields as measured by Goldmann perimetry | Initial visit, 2-week visit, 1-month visit, 3-month visit | 
| Change from Baseline Oct pRNFL (microns) | Nerve fiber thickness as measured by OCT | Initial visit, 3-month visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin