Optic Nerve DiseasesPhase 3NCT02376881
Erythropoietin in Methanol Associated Optic Neuropathy: A Phase-2 Clinical Trial (EPO-MAON Study)
A Phase 3 study testing Erythropoietin in people with Optic Nerve Diseases, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial 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… Read more about this study
- Who is it for?
- Ages 10 to 50 years
- Conditions the study is for
- Optic Nerve Diseases
- What is being tested?
- Erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteIran
- Study dates
- Mar 2015to 30 Mar 2020
- Phase
- Phase 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 10 to 50 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Iran1 site
Farabi Hospital, Tehran University of Medical Sciences
Tehran, 1336616351
About this study
Official title: Erythropoietin in Methanol Associated Optic Neuropathy
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.
Read more
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.
- Conditions
- Optic Nerve Diseases
- Being tested
- Erythropoietin, placebo
- Keywords
- Erythropoietin -Methanol - Optic Neuropathy
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ErythropoietinDrug
20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days
placeboOther
100 ml normal saline in 2 hr for 3 successive days
| Study group | Role | What they receive |
|---|---|---|
| EPO | Experimental | 20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days Receives: Drug: Erythropoietin |
| control group | Placebo comparator | 100 ml normal saline in 2 hr for 3 successive days Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: changes from baseline at week 12
Secondary outcomes (1)
peripapillary nerve fiber layer thickness
thickness of peripapillary nerve fiber layer using spectral domain OCT
Measured: changes from baseline at week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2015 (estimated)
- Study startMar 2015
- Primary completion30 Mar 2019
- Study completion30 Mar 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic Nerve DiseasesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Iran University of Medical Sciences
- Responsible party
- Principal investigator, Farzad Pakdel, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02376881
- Sponsor's protocol ID
- ERS139
- Status last verified
- Mar 2020
- First submitted
- 17 Feb 2015
- Last updated
- 10 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erythropoietin in Methanol Associated Optic Neuropathy
- ClinicalTrials.gov ID
- NCT02376881
- Acronym / sponsor ID
- ERS139
- Conditions
- Optic Nerve Diseases
- Keywords
- Erythropoietin -Methanol - Optic Neuropathy
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Collaborators
- Iran University of Medical Sciences
- Study start
- Mar 2015
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 30 Mar 2020 (estimated)
- First posted
- 3 Mar 2015 (estimated)
- 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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EPO | Experimental | Drug: Erythropoietin20,000 IU recombinant human erythropoietin IV infusion in 100 ml normal saline in 2 hr for 3 successive days |
| control group | Placebo comparator | Other: placebo100 ml normal saline in 2 hr for 3 successive days |
Who may qualify
- Ages
- 10 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
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 |
|---|---|---|
| Erythropoietin20,000 IU epo IV infusion in 100 ml normal saline in 2 hr for 3 successive days | Drug | EPO |
| placebo100 ml normal saline in 2 hr for 3 successive days | Other | control group |
Primary outcome
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
1 secondary outcome
peripapillary nerve fiber layer thickness
Time frame: changes from baseline at week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Optic Nerve Diseases
Active, not recruitingPhase 3
ENDOTHELION Study Group: Effect of Bosentan in NAION Patients
Ischemic Optic Neuropathy
Enrolling by invitationObservational study
Early Molecular Biomarkers for Differentiating Parkinsonian Syndromes
PARKINSON DISEASE (Disorder), Atypical Parkinsonism
Active, not recruiting
Improving Visual Field Deficits With Noninvasive Brain Stimulation
Visual Field Defect, Peripheral, Stroke
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Erythropoietin in people with Optic Nerve Diseases, run by Tehran University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 5 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 10 Mar 2020. 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 Iran. 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 phase mean?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best Corrected Visual Acuity (time frame: changes from baseline at week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Mar 2020.