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

Last updated: February 20, 2023
Sponsor: Asociación para Evitar la Ceguera en México
Overall Status: Active - Recruiting

Phase

2/3

Condition

Neurologic Disorders

Treatment

N/A

Clinical Study ID

NCT05748561
NEU-22-02
  • Ages 18-75
  • All Genders

Study 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?

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Both genres.
  • Age between 18 and 75 years.
  • Clinical diagnosis of toxic optic neuropathy (afferent pupillary defect, acquireddyschromatopsia, visual loss and bilateral prechiasmatic field defect).
  • Exposure with a temporal relationship of less than two weeks to a known toxicant forthe function of the optic nerve.
  • Up to 21 days from symptom onset.
  • Informed consent signature.

Exclusion

Exclusion Criteria:

  • History of previous optic neuropathy.
  • History of additional ophthalmological or neurological pathology that has causedpermanent visual loss.
  • History of previous treatment with intravenous methylprednisolone or some otherexperimental 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 cerebralvascular event.
  • Pregnancy or lactation.

Study Design

Total Participants: 18
Study Start date:
April 05, 2022
Estimated Completion Date:
April 05, 2024

Study 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

Connect with a study center

  • Jorge Cárdenas Belaunzarán

    Ciudad de mexico, 04030
    Mexico

    Active - Recruiting

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