Clinical trial

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

Name
NEU-22-02
Description
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?
Trial arms
Trial start
2022-04-05
Estimated PCD
2024-04-05
Trial end
2024-04-05
Status
Recruiting
Phase
Early phase I
Treatment
Recombinant human erythropoietin 4,000 UI and 2,000 UI
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Arms:
Experimental group
Other names:
Experimental Group
Methylprednisolone succinate 500 mg
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Arms:
Control group
Other names:
Control Group
Size
18
Primary endpoint
Change from Baseline Visual Capacity
Initial visit, 2-week visit, 1-month visit, 3-month visit
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2', 'PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized groups (2)\n\n1. Standard treatment (Intravenous methylprednisolone)\n2. Intervention (Intravenous erythropoietin)', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'DOUBLE', 'maskingDescription': "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.", 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 18, 'type': 'ESTIMATED'}}
Updated at
2023-02-28

1 organization

2 products

4 indications

Indication
Therapy
Indication
Erythropoietin