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

• Status: Recruiting
• Trial end date: 2024-04-05
• Target enrollment: 0
• Participant gender: All

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?

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Asociación para Evitar la Ceguera en México
• Treatments: Epoetin Alfa; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

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.