Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
NCT ID: NCT05748561
Last Updated: 2023-02-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2/PHASE3
18 participants
INTERVENTIONAL
2022-04-05
2024-04-05
Brief Summary
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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
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
1. Standard treatment (Intravenous methylprednisolone)
2. Intervention (Intravenous erythropoietin)
TREATMENT
DOUBLE
Study Groups
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Experimental group
The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.
Recombinant human erythropoietin 4,000 UI and 2,000 UI
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Control group
The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.
Methylprednisolone succinate 500 mg
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Interventions
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Recombinant human erythropoietin 4,000 UI and 2,000 UI
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Methylprednisolone succinate 500 mg
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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Asociación para Evitar la Ceguera en México
OTHER
Responsible Party
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Principal Investigators
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Jorge Cárdenas-Belaunzarán, MD, MSc
Role: STUDY_DIRECTOR
Asociación Para Evitar la Ceguera en México I.A.P
Elsa Hernández-Piñamora, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación Para Evitar la Ceguera en México I.A.P
Octavio Turcio-Aceves, MD
Role: PRINCIPAL_INVESTIGATOR
Asociación Para Evitar la Ceguera en México I.A.P
Locations
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Jorge Cárdenas Belaunzarán
Mexico City, , Mexico
Countries
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Central Contacts
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Facility Contacts
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Jorge Cárdenas-Belaunzarán, MD, MSc
Role: primary
References
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Tan H, Kang X, Zhong Y, Shen X, Cheng Y, Jiao Q, Deng L. Erythropoietin upregulates growth associated protein-43 expression and promotes retinal ganglion cell axonal regeneration in vivo after optic nerve crush. Neural Regen Res. 2012 Feb 5;7(4):295-301. doi: 10.3969/j.issn.1673-5374.2012.04.010.
Sharpe JA, Hostovsky M, Bilbao JM, Rewcastle NB. Methanol optic neuropathy: a histopathological study. Neurology. 1982 Oct;32(10):1093-100. doi: 10.1212/wnl.32.10.1093.
Naeser P. Optic nerve involvement in a case of methanol poisoning. Br J Ophthalmol. 1988 Oct;72(10):778-81. doi: 10.1136/bjo.72.10.778.
Sun Y, Calvert JW, Zhang JH. Neonatal hypoxia/ischemia is associated with decreased inflammatory mediators after erythropoietin administration. Stroke. 2005 Aug;36(8):1672-8. doi: 10.1161/01.STR.0000173406.04891.8c. Epub 2005 Jul 21.
Pakdel F, Sanjari MS, Naderi A, Pirmarzdashti N, Haghighi A, Kashkouli MB. Erythropoietin in Treatment of Methanol Optic Neuropathy. J Neuroophthalmol. 2018 Jun;38(2):167-171. doi: 10.1097/WNO.0000000000000614.
Sharma R, Marasini S, Sharma AK, Shrestha JK, Nepal BP. Methanol poisoning: ocular and neurological manifestations. Optom Vis Sci. 2012 Feb;89(2):178-82. doi: 10.1097/OPX.0b013e31823ee128.
Pakravan M, Esfandiari H, Sanjari N, Ghahari E. Erythropoietin as an adjunctive treatment for methanol-induced toxic optic neuropathy. Am J Drug Alcohol Abuse. 2016 Nov;42(6):633-639. doi: 10.1080/00952990.2016.1198800. Epub 2016 Jul 27.
Kashkouli MB, Pakdel F, Sanjari MS, Haghighi A, Nojomi M, Homaee MH, Heirati A. Erythropoietin: a novel treatment for traumatic optic neuropathy-a pilot study. Graefes Arch Clin Exp Ophthalmol. 2011 May;249(5):731-6. doi: 10.1007/s00417-010-1534-3. Epub 2010 Oct 2.
Entezari M, Esmaeili M, Yaseri M. A pilot study of the effect of intravenous erythropoetin on improvement of visual function in patients with recent indirect traumatic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2014 Aug;252(8):1309-13. doi: 10.1007/s00417-014-2691-6. Epub 2014 Jul 2.
Shayegannejad V, Shahzamani S, Dehghani A, Dast Borhan Z, Rahimi M, Mirmohammadsadeghi A. A double-blind, placebo-controlled trial of adding erythropoietin to intravenous methylprednisolone for the treatment of unilateral acute optic neuritis of unknown or demyelinative origin. Graefes Arch Clin Exp Ophthalmol. 2015 May;253(5):797-801. doi: 10.1007/s00417-014-2925-7. Epub 2015 Jan 22.
Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
Grzybowski A, Zulsdorff M, Wilhelm H, Tonagel F. Toxic optic neuropathies: an updated review. Acta Ophthalmol. 2015 Aug;93(5):402-410. doi: 10.1111/aos.12515. Epub 2014 Aug 27.
Karimi S, Arabi A, Shahraki T. Alcohol and the Eye. J Ophthalmic Vis Res. 2021 Apr 29;16(2):260-270. doi: 10.18502/jovr.v16i2.9089. eCollection 2021 Apr-Jun.
Kraut JA, Kurtz I. Toxic alcohol ingestions: clinical features, diagnosis, and management. Clin J Am Soc Nephrol. 2008 Jan;3(1):208-25. doi: 10.2215/CJN.03220807. Epub 2007 Nov 28.
Feizi S, Alemzadeh-Ansari M, Karimian F, Esfandiari H. Use of erythropoietin in ophthalmology: a review. Surv Ophthalmol. 2022 Mar-Apr;67(2):427-439. doi: 10.1016/j.survophthal.2021.06.002. Epub 2021 Jun 23.
Other Identifiers
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NEU-22-02
Identifier Type: -
Identifier Source: org_study_id