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Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)

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ClinicalTrials.gov Identifier: NCT02376881
Recruitment Status : Active, not recruiting
First Posted : March 3, 2015
Last Update Posted : March 10, 2020
Sponsor:
Collaborator:
Iran University of Medical Sciences
Information provided by (Responsible Party):
Farzad Pakdel, Tehran University of Medical Sciences

Brief Summary:

Methanol poisoning could result in severe optic neuropathy, profound visual loss and finally optic atrophy and permanent, irreversible optic atrophy and visual loss. Erythropoietin (EPO) has recently emerged as a drug that may help retinal ganglion cell loss and improve optic nerve function in some acquired types of optic neuropathy including traumatic optic neuropathy ,ischemic optic neuropathy and optic neuritis .It has been found that EPO offer some protection to the optic nerve and retina when they are injured and apoptosis process starts in retinal ganglion cells. The standard treatments of methanol poisoning are reanimation, metabolic stabilization, and inhibition of alcohol dehydrogenase by antagonist agents and elimination of toxic metabolites in early phase of toxicity by dialysis. However, after established optic neuropathy and visual loss there is little chance, if any, for visual recovery and no definitive treatment exist for treatment in these cases. The investigators recently reported the investigators preliminary results on 16 cases with methanol poisoning and found a beneficial effect of systemic erythropoietin in methanol associated optic neuropathy. Now, the investigators aim to investigate the effect of this agent in a clinical trial.

The purpose of this study is to determine if EPO could improves optic nerve function and help patients to improve visual recovery after methanol poisoning. Primary outcome measure would be best-corrected visual function and secondary outcome measure is ocular coherence tomography (OCT) measure of mean peripapillary nerve fiber layer thickness. Results of this study could be very valuable in formulating an evidence-based management of Methanol Associated Optic Neuropathy(MAON) and provide a high level evidence for changing the practice on management of methanol poisoning . Also it could provide valuable data for neuroprotective effects of erythropoietin specifically in neuroscience and ophthalmology.

The EPO-MAON trial is designed as a randomized, controlled, observer, and interpreter blinded mono-center pilot trial with two parallel groups and a primary endpoint of best corrected visual acuity during 120 days after enrollment into treatment groups.

All patients with methanol poisoning referred to Farabi hospital will be examined and evaluated for best-corrected visual acuity, pupillary light reflexes, relative afferent pupillary defect, color vision (Ishihara plates), fundus photography, slit lamp exam of anterior segment and fundus exam with 78 D lens.


Condition or disease Intervention/treatment Phase
Optic Nerve Diseases Drug: Erythropoietin Other: placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Official Title: Erythropoietin in Methanol Associated Optic Neuropathy
Study Start Date : March 2015
Actual Primary Completion Date : March 30, 2019
Estimated Study Completion Date : March 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EPO
20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days
Drug: Erythropoietin
20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days

Placebo Comparator: control group
100 ml normal saline in 2 hr for 3 successive days
Other: placebo
100 ml normal saline in 2 hr for 3 successive days




Primary Outcome Measures :
  1. Best Corrected Visual Acuity [ Time Frame: changes from baseline at week 12 ]
    centra visual acuity changes from baseline by C Landolt chart after refractive error correction and pinhole if not corrected by glasses alone-converted to logMAR by special prepared table


Secondary Outcome Measures :
  1. peripapillary nerve fiber layer thickness [ Time Frame: changes from baseline at week 12 ]
    thickness of peripapillary nerve fiber layer using spectral domain OCT



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 50 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with confirmed MAON
  2. age 10-50 years old
  3. Best Corrected Visual Acuity(BCVA)<20/30 or Visual field defect in 10 degrees of central fixation shown in visual field perimetry C-24 SITA(Swedish interactive threshold algorithm)
  4. those who can respond to questions and undergo diagnostic tests.

Exclusion Criteria:

  1. previous intra-ocular or ocular surface surgeries;
  2. those who do not agree to perform ophthalmic exams explained to them by the examiner ophthalmologists
  3. those who have history of diabetes mellitus, cardiovascular disease, cerebrovascular disease.
  4. Those who had received corticosteroid within past 1 month.
  5. Those who has any cornea, lens, retina, optic nerve, choroid or central nervous system(CNS) disease that could potentially affect visual function.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02376881


Locations
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Iran, Islamic Republic of
Farabi Hospital, Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of, 1336616351
Sponsors and Collaborators
Tehran University of Medical Sciences
Iran University of Medical Sciences
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Responsible Party: Farzad Pakdel, Prof., Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02376881    
Other Study ID Numbers: ERS139
First Posted: March 3, 2015    Key Record Dates
Last Update Posted: March 10, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Farzad Pakdel, Tehran University of Medical Sciences:
Erythropoietin -Methanol - Optic Neuropathy
Additional relevant MeSH terms:
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Optic Nerve Diseases
Nervous System Diseases
Cranial Nerve Diseases
Eye Diseases
Epoetin Alfa
Hematinics