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

Asociación para Evitar la Ceguera en México

Status and phase: Enrolling; Phase 3; Phase 2

Conditions: Treatment; Methylprednisolone; Erythropoietin; Toxic Optic Neuropathy

Treatments: Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI; Drug: Methylprednisolone succinate 500 mg

Study type: Interventional

Funder types: Other

Identifiers

NCT05748561

NEU-22-02

Details and patient eligibility

About

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?

Full 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

Enrollment: 18 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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18 participants in 2 patient groups, including a placebo group

Experimental group

Experimental group

Description:

The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.

Treatment:

Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI

Control group

Placebo Comparator group

Description:

The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.

Treatment:

Drug: Methylprednisolone succinate 500 mg