Erythropoietin, Methylprednisolone, Toxic Optic Neuropathy, Treatment
Conditions
Keywords
Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin
Brief summary
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
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) 1. Standard treatment (intravenous methylprednisolone) 2. 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
Interventions
DRUGRecombinant human erythropoietin 4,000 UI and 2,000 UI
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
DRUGMethylprednisolone succinate 500 mg
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Sponsors
Asociación para Evitar la Ceguera en México
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
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.
Intervention model description
Randomized groups (2) 1. Standard treatment (Intravenous methylprednisolone) 2. Intervention (Intravenous erythropoietin)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Visual Capacity | Initial visit, 2-week visit, 1-month visit, 3-month visit | Best corrected visual acuity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from Baseline Color vision | Initial visit, 2-week visit, 1-month visit, 3-month visit | Color vision as measured by Ishihara plates |
| Change from Baseline Visual field defect | Initial visit, 2-week visit, 1-month visit, 3-month visit | Visual fields as measured by Goldmann perimetry |
| Change from Baseline Oct pRNFL (microns) | Initial visit, 3-month visit | Nerve fiber thickness as measured by OCT |
Countries
Mexico
Contacts
Primary ContactJorge Cárdenas-Belaunzarán, MD, MSc
Backup ContactOctavio Turcio-Aceves, MD
Outcome results
None listed