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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE February 17, 2015
First Posted Date  ICMJE March 3, 2015
Last Update Posted Date March 10, 2020
Study Start Date  ICMJE March 2015
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 24, 2016)
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
Original Primary Outcome Measures  ICMJE
 (submitted: February 24, 2015)
visual function [ Time Frame: changes frome baseline at week 12 ]
Visual function 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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 24, 2016)
peripapillary nerve fiber layer thickness [ Time Frame: changes from baseline at week 12 ]
thickness of peripapillary nerve fiber layer using spectral domain OCT
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)
Official Title  ICMJE Erythropoietin in Methanol Associated Optic Neuropathy
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
Condition  ICMJE Optic Nerve Diseases
Intervention  ICMJE
  • Drug: Erythropoietin
    20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days
  • Other: placebo
    100 ml normal saline in 2 hr for 3 successive days
Study Arms  ICMJE
  • Experimental: EPO
    20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days
    Intervention: Drug: Erythropoietin
  • Placebo Comparator: control group
    100 ml normal saline in 2 hr for 3 successive days
    Intervention: Other: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 10, 2018)
24
Original Estimated Enrollment  ICMJE
 (submitted: February 24, 2015)
30
Estimated Study Completion Date  ICMJE March 30, 2020
Actual Primary Completion Date March 30, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02376881
Other Study ID Numbers  ICMJE ERS139
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Farzad Pakdel, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Iran University of Medical Sciences
Investigators  ICMJE Not Provided
PRS Account Tehran University of Medical Sciences
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP