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

February 20, 2023 updated by: Asociación para Evitar la Ceguera en México

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?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

18

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
      • Ciudad de mexico, Mexico, 04030
        • Recruiting
        • Jorge Cárdenas Belaunzarán
        • Contact:
          • Jorge Cárdenas-Belaunzarán, MD, MSc
          • Phone Number: 1207 5510841400

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental group
The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Other Names:
  • Experimental Group
Placebo Comparator: Control group
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
Drug: Methylprednisolone succinate 500 mg
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Other Names:
  • Control Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Visual Capacity
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Baseline Color vision
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Color vision as measured by Ishihara plates
Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Time Frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Visual fields as measured by Goldmann perimetry
Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Time Frame: Initial visit, 3-month visit
Nerve fiber thickness as measured by OCT
Initial visit, 3-month visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Asociación para Evitar la Ceguera en México

Investigators

  • Study Director: Jorge Cárdenas-Belaunzarán, MD, MSc, Asociación para Evitar la Ceguera en México I.A.P
  • Principal Investigator: Elsa Hernández-Piñamora, MD, Asociación para Evitar la Ceguera en México I.A.P
  • Principal Investigator: Octavio Turcio-Aceves, MD, Asociación para Evitar la Ceguera en México I.A.P

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 5, 2022

Primary Completion (Anticipated)

April 5, 2024

Study Completion (Anticipated)

April 5, 2024

Study Registration Dates

First Submitted

February 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Estimate)

February 28, 2023

Study Record Updates

Last Update Posted (Estimate)

February 28, 2023

Last Update Submitted That Met QC Criteria

February 20, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NEU-22-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

This study is confidential and no information will be shared with the participants.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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