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

Primary Purpose

Optic Nerve Diseases

Status
Unknown status
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Erythropoietin
placebo
Sponsored by
Tehran University of Medical Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Optic Nerve Diseases focused on measuring Erythropoietin -Methanol - Optic Neuropathy

Eligibility Criteria

10 Years - 50 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Farabi Hospital, Tehran University of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

EPO

control group

Arm Description

20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days

100 ml normal saline in 2 hr for 3 successive days

Outcomes

Primary Outcome Measures

Best Corrected Visual Acuity
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

peripapillary nerve fiber layer thickness
thickness of peripapillary nerve fiber layer using spectral domain OCT

Full Information

First Posted
February 17, 2015
Last Updated
March 9, 2020
Sponsor
Tehran University of Medical Sciences
Collaborators
Iran University of Medical Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02376881
Brief Title
Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)
Official Title
Erythropoietin in Methanol Associated Optic Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 30, 2019 (Actual)
Study Completion Date
March 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
Collaborators
Iran University of Medical Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Nerve Diseases
Keywords
Erythropoietin -Methanol - Optic Neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
EPO
Arm Type
Experimental
Arm Description
20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
100 ml normal saline in 2 hr for 3 successive days
Intervention Type
Drug
Intervention Name(s)
Erythropoietin
Intervention Description
20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days
Intervention Type
Other
Intervention Name(s)
placebo
Intervention Description
100 ml normal saline in 2 hr for 3 successive days
Primary Outcome Measure Information:
Title
Best Corrected Visual Acuity
Description
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
Time Frame
changes from baseline at week 12
Secondary Outcome Measure Information:
Title
peripapillary nerve fiber layer thickness
Description
thickness of peripapillary nerve fiber layer using spectral domain OCT
Time Frame
changes from baseline at week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients with confirmed MAON age 10-50 years old 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) those who can respond to questions and undergo diagnostic tests. Exclusion Criteria: previous intra-ocular or ocular surface surgeries; those who do not agree to perform ophthalmic exams explained to them by the examiner ophthalmologists those who have history of diabetes mellitus, cardiovascular disease, cerebrovascular disease. Those who had received corticosteroid within past 1 month. Those who has any cornea, lens, retina, optic nerve, choroid or central nervous system(CNS) disease that could potentially affect visual function.
Facility Information:
Facility Name
Farabi Hospital, Tehran University of Medical Sciences
City
Tehran
ZIP/Postal Code
1336616351
Country
Iran, Islamic Republic of

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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