Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathi… (NCT05748561) | Clinical Trial Compass
UnknownPhase 2/3
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
Mexico18 participantsStarted 2022-04-05
Plain-language 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?
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.