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

  • STATUS
    Recruiting
  • participants needed
    18
  • sponsor
    Asociación para Evitar la Ceguera en México
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Updated on 28 February 2023
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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?

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

Details
Condition Toxic Optic Neuropathy, Treatment, Methylprednisolone, Erythropoietin
Age 18years - 75years
Treatment Recombinant human erythropoietin 4,000 UI and 2,000 UI, Methylprednisolone succinate 500 mg
Clinical Study IdentifierNCT05748561
SponsorAsociación para Evitar la Ceguera en México
Last Modified on28 February 2023

Eligibility

 Yes No Not Sure

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
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