Toxic Optic NeuropathyPhase 2/3NCT05748561
Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
A Phase 2/3 study testing Recombinant human erythropoietin 4,000 UI and 2,000 UI and Methylprednisolone succinate 500 mg in people with Toxic Optic Neuropathy and Treatment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Toxic Optic Neuropathy, Treatment, Methylprednisolone
- What is being tested?
- Recombinant human erythropoietin 4,000 UI and 2,000 UI and Methylprednisolone succinate 500 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 18 participants
- Where
- 1 siteMexico
- Study dates
- 5 Apr 2022to 5 Apr 2024
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 9Show fewer
- Patients with a history of thromboembolic event.
- Patients with a history of coronary heart disease, myocardial infarction or cerebral vascular event.
- Pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Jorge Cárdenas Belaunzarán
Mexico City, 04030
Jorge Cárdenas-Belaunzarán, MD, MSc, 5510841400 ext. 1207
About this study
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?
Read the 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)
- Standard treatment (intravenous methylprednisolone)
- 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
- Toxic Optic Neuropathy, Treatment, Methylprednisolone, Erythropoietin
- Being tested
- Recombinant human erythropoietin 4,000 UI and 2,000 UI, Methylprednisolone succinate 500 mg
- Keywords
- Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin
- Medical subject headings
- Toxic Optic Neuropathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant human erythropoietin 4,000 UI and 2,000 UIDrug
Also called Experimental Group
Intravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days)
Methylprednisolone succinate 500 mgDrug
Also called Control Group
Intravenous Methylprednisolone succinate (1 g daily for 5 days)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | The patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days. Receives: 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. Receives: Drug: Methylprednisolone succinate 500 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Visual Capacity
Best corrected visual acuity
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Secondary outcomes (3)
Change from Baseline Color vision
Color vision as measured by Ishihara plates
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Visual fields as measured by Goldmann perimetry
Measured: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Nerve fiber thickness as measured by OCT
Measured: Initial visit, 3-month visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2023
- Study start5 Apr 2022
- Primary completion5 Apr 2024 (estimated)
- Study completion5 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Toxic Optic NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized groups (2) 1. Standard treatment (Intravenous methylprednisolone) 2. Intervention (Intravenous erythropoietin)
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asociación para Evitar la Ceguera en México
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jorge Cárdenas-Belaunzarán, MD, MSc, Study director, Asociación Para Evitar la Ceguera en México I.A.PElsa Hernández-Piñamora, MD, Principal investigator, Asociación Para Evitar la Ceguera en México I.A.POctavio Turcio-Aceves, MD, Principal investigator, Asociación Para Evitar la Ceguera en México I.A.P
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05748561
- Sponsor's protocol ID
- NEU-22-02
- Status last verified
- Feb 2023
- First submitted
- 20 Feb 2023
- Last updated
- 28 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study is confidential and no information will be shared with the participants.
Publications
Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
PubMed 19668477Grzybowski 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.
PubMed 25159832Karimi 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.
PubMed 34055263Kraut 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.
PubMed 18045860Tan 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.
PubMed 25806072Sharpe 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.
PubMed 6889696Naeser 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.
PubMed 3191081Sun 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.
PubMed 16040592Pakdel 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.
PubMed 29300238Sharma 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.
PubMed 22127151Pakravan 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.
PubMed 27463192Kashkouli 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.
PubMed 20890611Entezari 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.
PubMed 24986593Shayegannejad 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.
PubMed 25605544Feizi 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.
PubMed 34157346
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Methylprednisolone and Intravenous Erythropoietin in Toxic Optic Neuropathies: Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT05748561
- Acronym / sponsor ID
- NEU-22-02
- Conditions
- Toxic Optic Neuropathy, Treatment, Methylprednisolone, Erythropoietin
- Keywords
- Toxic Optic Neuropathy, Methylprednisolone, Erythropoietin
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Asociación para Evitar la Ceguera en MéxicoUniversity, hospital or other
- Study start
- 5 Apr 2022 (actual)
- Primary completion
- 5 Apr 2024 (estimated)
- Study completion
- 5 Apr 2024 (estimated)
- First posted
- 28 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
- Standard treatment (intravenous methylprednisolone)
- 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized groups (2) 1. Standard treatment (Intravenous methylprednisolone) 2. Intervention (Intravenous erythropoietin)
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Drug: Recombinant human erythropoietin 4,000 UI and 2,000 UIThe patients will receive intravenous erythropoietin - 10,000 IU every 24 hours for 5 days. |
| Control group | Placebo comparator | Drug: Methylprednisolone succinate 500 mgThe patients will receive intravenous methylprednisolone - 1 g every 24 hours for 5 days. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant human erythropoietin 4,000 UI and 2,000 UIAlso: Experimental GroupIntravenous recombinant human erythropoietin (10,000 IU every 24 hours for 5 days) | Drug | Experimental group |
| Methylprednisolone succinate 500 mgAlso: Control GroupIntravenous Methylprednisolone succinate (1 g daily for 5 days) | Drug | Control group |
Primary outcome
Change from Baseline Visual Capacity
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Best corrected visual acuity
3 secondary outcomes
Change from Baseline Color vision
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Visual field defect
Time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit
Change from Baseline Oct pRNFL (microns)
Time frame: Initial visit, 3-month visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2023.
- Background: PubMed 19668477Behbehani R. Clinical approach to optic neuropathies. Clin Ophthalmol. 2007 Sep;1(3):233-46.
- Background: PubMed 25159832Grzybowski 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.
- Background: PubMed 34055263Karimi 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.
- Background: PubMed 18045860Kraut 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.
- Background: PubMed 25806072Tan 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.
- Background: PubMed 6889696Sharpe 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.
- Background: PubMed 3191081Naeser 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.
- Background: PubMed 16040592Sun 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.
- Background: PubMed 29300238Pakdel 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.
- Background: PubMed 22127151Sharma 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.
- Background: PubMed 27463192Pakravan 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.
- Background: PubMed 20890611Kashkouli 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.
- Individual participant dataSharing planned: No. This study is confidential and no information will be shared with the participants.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jorge Cárdenas-Belaunzarán, MD, MSc study director
Asociación Para Evitar la Ceguera en México I.A.P
Elsa Hernández-Piñamora, MD principal investigator
Asociación Para Evitar la Ceguera en México I.A.P
Octavio Turcio-Aceves, MD principal investigator
Asociación Para Evitar la Ceguera en México I.A.P
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Recombinant human erythropoietin 4,000 UI and 2,000 UI and Methylprednisolone succinate 500 mg in people with Toxic Optic Neuropathy and Treatment, run by Asociación para Evitar la Ceguera en México at 1 site in Mexico.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Mexico. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jorge Cárdenas-Belaunzarán, MD, MSc (5544600113, jorge.cardenas@apec.com.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Visual Capacity (time frame: Initial visit, 2-week visit, 1-month visit, 3-month visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05748561, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2023.