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

Treatment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05748561
• Other study ID #: NEU-22-02
• Status: Recruiting
• Phase: Phase 2/Phase 3
• Start date: April 5, 2022
• Est. completion date: April 5, 2024

Study information

• Verified date: February 2023
• Source: Asociación para Evitar la Ceguera en México
• Contact: Jorge Cárdenas-Belaunzarán, MD, MSc
• Phone: 5544600113
• Email: jorge.cardenas[@]apec.com.mx
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 18
• Est. completion date: April 5, 2024
• Est. primary completion date: April 5, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Erythropoietin
• Methylprednisolone
• Optic Nerve Diseases
• Peripheral Nervous System Diseases
• Treatment

Intervention

Drug:
• 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)

Locations

Country	Name	City	State
Mexico	Jorge Cárdenas Belaunzarán	Ciudad de mexico

Sponsors (1)

Lead Sponsor	Collaborator
Asociación para Evitar la Ceguera en México

Country where clinical trial is conducted

Mexico, 

References & Publications (15)

Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46. — View Citation

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. — View Citation

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. — View Citation

Grzybowski A, Zulsdorff M, Wilhelm H, Tonagel F. Toxic optic neuropathies: an updated review. Acta Ophthalmol. 2015 Aug;93(5):402-10. doi: 10.1111/aos.12515. Epub 2014 Aug 27. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline Visual Capacity	Best corrected visual acuity	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Color vision	Color vision as measured by Ishihara plates	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Visual field defect	Visual fields as measured by Goldmann perimetry	Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary	Change from Baseline Oct pRNFL (microns)	Nerve fiber thickness as measured by OCT	Initial visit, 3-month visit