NCT05748561

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

• Status: Unknown
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Asociación para Evitar la Ceguera en México · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Conditions

• Toxic Optic Neuropathy
• Treatment
• Methylprednisolone
• Erythropoietin

Interventions

Type	Name	Description
DRUG	Recombinant human erythropoietin 4,000 UI and 2,000 UI	Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
DRUG	Methylprednisolone succinate 500 mg	Intravenous Methylprednisolone succinate (1 g daily for 5 days)

Timeline

• Start date: 2022-04-05
• Primary completion: 2024-04-05
• Completion: 2024-04-05
• First posted: 2023-02-28
• Last updated: 2023-02-28

Locations

1 site across 1 country: Mexico