A Phase 2/3 interventional study of Recombinant human erythropoietin 4,000 UI and 2,000 UI and Methylprednisolone succinate 500 mg in Toxic Optic Neuropathy, Treatment and Methylprednisolone, sponsored by Asociación para Evitar la Ceguera en México. Status unknown at 1 site in Mexico. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-02-28.
Sponsored by Asociación para Evitar la Ceguera en México · Phase 2/3, Interventional, and Treatment
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:
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)
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
Asociación para Evitar la Ceguera en México is the lead sponsor of 60 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
Drug: Methylprednisolone succinate 500 mg
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Also known as: Experimental Group
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Also known as: Control Group
Change from Baseline Visual Capacity
Best corrected visual acuity
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Color vision
Color vision as measured by Ishihara plates
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Visual fields as measured by Goldmann perimetry
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Nerve fiber thickness as measured by OCT
Time frame: Initial visit, 3-month visit
Plan to share: No — This study is confidential and no information will be shared with the participants.
Started Apr 2022 (actual). Primary completion is estimated for Apr 2024, 24 months after the start.
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This study is status unknown, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.
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Toxic Optic Neuropathy
Asociación para Evitar la Ceguera en México