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

NCT05748561 | Unknown Phase 2 DMC

• 1 other identifier: NEU-22-02
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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?

Conditions

Toxic Optic Neuropathy; Treatment; Methylprednisolone; Erythropoietin

Keywords

Toxic Optic Neuropathy; Methylprednisolone; Erythropoietin

Outcome Measures

Primary Outcomes (1)

• Change from Baseline Visual Capacity

  Best corrected visual acuity

  Initial visit, 2-week visit, 1-month visit, 3-month visit

Secondary Outcomes (3)

• Change from Baseline Color vision

  Initial visit, 2-week visit, 1-month visit, 3-month visit

• Change from Baseline Visual field defect

  Initial visit, 2-week visit, 1-month visit, 3-month visit

• Change from Baseline Oct pRNFL (microns)

  Initial visit, 3-month visit

Study Arms (2)

Experimental group

EXPERIMENTAL

The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days.

Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UI

Control group

PLACEBO COMPARATOR

The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days.

Drug: Methylprednisolone succinate 500 mg

Interventions

Recombinant human erythropoietin 4,000 UI and 2,000 UI DRUG

Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)

Also known as: Experimental Group

Experimental group

Methylprednisolone succinate 500 mg DRUG

Intravenous Methylprednisolone succinate (1 g daily for 5 days)

Also known as: Control Group

Control group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Asociación para Evitar la Ceguera en México: lead

Study Sites (1)

Jorge Cárdenas Belaunzarán

Mexico City, 04030, Mexico

RECRUITING

Related Publications (15)

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

  PMID: 19668477 BACKGROUND

• 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.

  PMID: 25159832 BACKGROUND

• 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.

  PMID: 34055263 BACKGROUND

• 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.

  PMID: 18045860 BACKGROUND

• 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.

  PMID: 25806072 BACKGROUND

• 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.

  PMID: 6889696 BACKGROUND

• 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.

  PMID: 3191081 BACKGROUND

• 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.

  PMID: 16040592 BACKGROUND

• 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.

  PMID: 29300238 BACKGROUND

• 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.

  PMID: 22127151 BACKGROUND

• 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.

  PMID: 27463192 BACKGROUND

• 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.

  PMID: 20890611 BACKGROUND

• 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.

  PMID: 24986593 BACKGROUND

• 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.

  PMID: 25605544 BACKGROUND

• 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.

  PMID: 34157346 BACKGROUND

MeSH Terms

Conditions

Toxic Optic Neuropathy

Interventions

Methylprednisolone Hemisuccinate; Control Groups

Condition Hierarchy (Ancestors)

Optic Nerve Injuries; Cranial Nerve Injuries; Cranial Nerve Diseases; Nervous System Diseases; Optic Nerve Diseases; Craniocerebral Trauma; Trauma, Nervous System; Eye Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Methylprednisolone; Prednisolone; Pregnadienetriols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Jorge Cárdenas-Belaunzarán, MD, MSc

  Asociación Para Evitar la Ceguera en México I.A.P

  STUDY DIRECTOR

• Elsa Hernández-Piñamora, MD

  Asociación Para Evitar la Ceguera en México I.A.P

  PRINCIPAL INVESTIGATOR

• Octavio Turcio-Aceves, MD

  Asociación Para Evitar la Ceguera en México I.A.P

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jorge Cárdenas-Belaunzarán, MD, MSc

CONTACT

5544600113; jorge.cardenas@apec.com.mx

Octavio Turcio-Aceves, MD

CONTACT

5526951290; octavioturcioaceves@gmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized groups (2) 1. Standard treatment (Intravenous methylprednisolone) 2. Intervention (Intravenous erythropoietin)

Study Record Dates

• First Submitted: February 20, 2023
• First Posted: February 28, 2023
• Study Start: April 5, 2022
• Primary Completion: April 5, 2024
• Study Completion: April 5, 2024
• Last Updated: February 28, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)