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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?
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)
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental group | Experimental | The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days. |
|
| Control group | Placebo Comparator | The patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant human erythropoietin 4,000 UI and 2,000 UI | Drug | Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Visual Capacity | Best corrected visual acuity | Initial visit, 2-week visit, 1-month visit, 3-month visit |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline Color vision | Color vision as measured by Ishihara plates | Initial visit, 2-week visit, 1-month visit, 3-month visit |
| Change from Baseline Visual field defect | Visual fields as measured by Goldmann perimetry |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jorge Cárdenas-Belaunzarán, MD, MSc | Contact | 5544600113 | jorge.cardenas@apec.com.mx | |
| Octavio Turcio-Aceves, MD | Contact | 5526951290 | octavioturcioaceves@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jorge Cárdenas Belaunzarán | Recruiting | Mexico City | 04030 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19668477 | Background | Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46. | |
| 25159832 | 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. |
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This study is confidential and no information will be shared with the participants.
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Randomized groups (2)
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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.
| Methylprednisolone succinate 500 mg | Drug | Intravenous Methylprednisolone succinate (1 g daily for 5 days) |
|
|
| Initial visit, 2-week visit, 1-month visit, 3-month visit |
| Change from Baseline Oct pRNFL (microns) | Nerve fiber thickness as measured by OCT | Initial visit, 3-month visit |
| Octavio Turcio-Aceves, MD | Asociación Para Evitar la Ceguera en México I.A.P | Principal Investigator |
| 34055263 | 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. |
| 18045860 | 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. |
| 25806072 | 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. |
| 6889696 | 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. |
| 3191081 | 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. |
| 16040592 | 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. |
| 29300238 | 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. |
| 22127151 | 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. |
| 27463192 | 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. |
| 20890611 | 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. |
| 24986593 | 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. |
| 25605544 | 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. |
| 34157346 | 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. |
| ID | Term |
|---|---|
| D000081028 | Toxic Optic Neuropathy |
| ID | Term |
|---|---|
| D020221 | Optic Nerve Injuries |
| D020209 | Cranial Nerve Injuries |
| D003389 | Cranial Nerve Diseases |
| D009422 | Nervous System Diseases |
| D009901 | Optic Nerve Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D005128 | Eye Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D008776 | Methylprednisolone Hemisuccinate |
| D035061 | Control Groups |
| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
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