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

Phase 2

Recruiting

• Conditions: Toxic Optic Neuropathy; Treatment; Methylprednisolone; Erythropoietin
• Interventions: Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI; Drug: Methylprednisolone succinate 500 mg

• Registration Number: NCT05748561
• Lead Sponsor: Asociación para Evitar la Ceguera en México

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

Study Timeline

• Study Start: 2022-04-05
• Status Verified: 2023-02
• Study First Submitted: 2023-02-20
• Study First Submitted QC: 2023-02-20
• Last Update Submitted: 2023-02-20
• Study First Posted: 2023-02-28
• Last Update Posted: 2023-02-28
• Primary Completion: 2024-04-05
• Study Completion: 2024-04-05

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 18

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Recombinant human erythropoietin 4,000 UI and 2,000 UI	The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
Control group	Methylprednisolone succinate 500 mg	The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.

Primary Outcome Measures

Name	Time	Method
Change from Baseline Visual Capacity	Initial visit, 2-week visit, 1-month visit, 3-month visit	Best corrected visual acuity

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Jorge Cárdenas Belaunzarán; 🇲🇽 Ciudad de mexico, Mexico