Clinical trial NCT05748561: 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
Overall status: UNKNOWN
Phase: PHASE2
PHASE3
Conditions: Toxic Optic Neuropathy
Treatment
Methylprednisolone
Erythropoietin
Keywords: Toxic Optic Neuropathy
Methylprednisolone
Erythropoietin
Lead sponsor: Asociación para Evitar la Ceguera en México
Sponsor class: OTHER
First posted: 2023-02-28
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized groups (2)

1. Standard treatment (Intravenous methylprednisolone)
2. Intervention (Intravenous erythropoietin)
Primary purpose: TREATMENT

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)

1. Standard treatment (intravenous methylprednisolone)
2. 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

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.

Primary outcomes:
measure: Change from Baseline Visual Capacity
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary outcomes:
measure: Change from Baseline Color vision
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
measure: Change from Baseline Visual field defect
timeFrame: Initial visit, 2-week visit, 1-month visit, 3-month visit
measure: Change from Baseline Oct pRNFL (microns)
timeFrame: Initial visit, 3-month visit
Other outcomes:
Locations:
city: Ciudad de mexico
country: Mexico
facility: Jorge Cárdenas Belaunzarán
Study officials:
affiliation: Asociación Para Evitar la Ceguera en México I.A.P
name: Jorge Cárdenas-Belaunzarán, MD, MSc
role: STUDY_DIRECTOR
affiliation: Asociación Para Evitar la Ceguera en México I.A.P
name: Elsa Hernández-Piñamora, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Asociación Para Evitar la Ceguera en México I.A.P
name: Octavio Turcio-Aceves, MD
role: PRINCIPAL_INVESTIGATOR
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