Back to resultsEffect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
Primary Purpose
Toxic Optic Neuropathy, Treatment, Methylprednisolone
Status
Recruiting
Phase
Phase 2
Locations
Mexico
Study Type
Interventional
Intervention
Recombinant human erythropoietin 4,000 UI and 2,000 UI
Methylprednisolone succinate 500 mg
Sponsored by
About this trial
This is an interventional treatment trial for Toxic Optic Neuropathy focused on measuring Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin
Eligibility 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.
Sites / Locations
- Jorge Cárdenas BelaunzaránRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Experimental group
Control group
Arm Description
The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
Outcomes
Primary Outcome Measures
Change from Baseline Visual Capacity
Best corrected visual acuity
Secondary Outcome Measures
Change from Baseline Color vision
Color vision as measured by Ishihara plates
Change from Baseline Visual field defect
Visual fields as measured by Goldmann perimetry
Change from Baseline Oct pRNFL (microns)
Nerve fiber thickness as measured by OCT
Full Information
NCT ID
NCT05748561
First Posted
February 20, 2023
Last Updated
February 20, 2023
Sponsor
Asociación para Evitar la Ceguera en México
1. Study Identification
Unique Protocol Identification Number
NCT05748561
Brief Title
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
Official Title
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 5, 2022 (Actual)
Primary Completion Date
April 5, 2024 (Anticipated)
Study Completion Date
April 5, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Asociación para Evitar la Ceguera en México
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. 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?
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Toxic Optic Neuropathy, Treatment, Methylprednisolone, Erythropoietin
Keywords
Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomized groups (2)
Standard treatment (Intravenous methylprednisolone)
Intervention (Intravenous erythropoietin)
Masking
ParticipantOutcomes 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.
Allocation
Randomized
Enrollment
18 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
Intervention Type
Drug
Intervention Name(s)
Recombinant human erythropoietin 4,000 UI and 2,000 UI
Other Intervention Name(s)
Experimental Group
Intervention Description
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone succinate 500 mg
Other Intervention Name(s)
Control Group
Intervention Description
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Primary Outcome Measure Information:
Title
Change from Baseline Visual Capacity
Description
Best corrected visual acuity
Time Frame
Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary Outcome Measure Information:
Title
Change from Baseline Color vision
Description
Color vision as measured by Ishihara plates
Time Frame
Initial visit, 2-week visit, 1-month visit, 3-month visit
Title
Change from Baseline Visual field defect
Description
Visual fields as measured by Goldmann perimetry
Time Frame
Initial visit, 2-week visit, 1-month visit, 3-month visit
Title
Change from Baseline Oct pRNFL (microns)
Description
Nerve fiber thickness as measured by OCT
Time Frame
Initial visit, 3-month visit
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jorge Cárdenas-Belaunzarán, MD, MSc
Phone
5544600113
Email
jorge.cardenas@apec.com.mx
First Name & Middle Initial & Last Name or Official Title & Degree
Octavio Turcio-Aceves, MD
Phone
5526951290
Email
octavioturcioaceves@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jorge Cárdenas-Belaunzarán, MD, MSc
Organizational Affiliation
Asociación Para Evitar la Ceguera en México I.A.P
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Elsa Hernández-Piñamora, MD
Organizational Affiliation
Asociación Para Evitar la Ceguera en México I.A.P
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Octavio Turcio-Aceves, MD
Organizational Affiliation
Asociación Para Evitar la Ceguera en México I.A.P
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jorge Cárdenas Belaunzarán
City
Ciudad de mexico
ZIP/Postal Code
04030
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jorge Cárdenas-Belaunzarán, MD, MSc
Phone
5510841400
Ext
1207
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
This study is confidential and no information will be shared with the participants.
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Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
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