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

Sponsor

Asociación para Evitar la Ceguera en México (Other)

Overall Status

Recruiting

CT.gov ID

NCT05748561

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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?

Condition or Disease	Intervention/Treatment	Phase
Toxic Optic Neuropathy Treatment Methylprednisolone Erythropoietin	Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI Drug: Methylprednisolone succinate 500 mg	Phase 2/Phase 3

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)

Standard treatment (intravenous methylprednisolone)
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 Design

Study Type:

Interventional

Anticipated Enrollment :

18 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized groups (2) Standard treatment (Intravenous methylprednisolone) Intervention (Intravenous erythropoietin)Randomized groups (2) Standard treatment (Intravenous methylprednisolone) Intervention (Intravenous erythropoietin)

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 5, 2022

Anticipated Primary Completion Date :

Apr 5, 2024

Anticipated Study Completion Date :

Apr 5, 2024

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change from Baseline Visual Capacity [Initial visit, 2-week visit, 1-month visit, 3-month visit]
Best corrected visual acuity

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Jorge Cárdenas Belaunzarán	Ciudad de mexico		Mexico	04030

Sponsors and Collaborators

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