NAION Treatment With Oral Prednisolone and Erythropoietin Injection (NAION)
Primary Purpose
Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Status
Unknown status
Phase
Phase 2
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Oral prednisolone administration 50 mg
Intravenous Erythropoietin injection
Sponsored by
About this trial
This is an interventional treatment trial for Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Eligibility Criteria
Inclusion criteria:
- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals
Exclusion criteria:
- Glaucoma or any ocular, neurologic or systemic disease affecting the vision
- Abnormal laboratory test results such as ESR and CRP
- History of ocular surgery
- History of receiving medication for NAION
- Uncontrolled systemic disease such as diabetes or hypertension
- Contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression
- Contraindications of erythropoietin administration, such as polycythemia
- Unwillingness to participate in the study
Sites / Locations
- Ophthalmic Research CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Oral prednisolone administration
Intravenous Erythropoietin injection
Arm Description
50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
2. 1000 units of erythropoietin every 12 hours for three days
Outcomes
Primary Outcome Measures
Improvement in indices visual acuity compared to normal course of the disease
Snellen visual acuity chart
Improvement in indices visual field
Mean deviation and pattern standard deviation
Improvement in indices retinal nerve fiber thickness
peripapillary Optical Coherence Tomography
Secondary Outcome Measures
Full Information
NCT ID
NCT03715881
First Posted
June 12, 2018
Last Updated
October 22, 2018
Sponsor
Shahid Beheshti University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT03715881
Brief Title
NAION Treatment With Oral Prednisolone and Erythropoietin Injection
Acronym
NAION
Official Title
Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 1, 2018 (Anticipated)
Primary Completion Date
December 1, 2018 (Anticipated)
Study Completion Date
March 1, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shahid Beheshti University of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
This randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. The first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. The second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. In addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. The third group will receive placebo. Eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. SITA standard visual field testing will be done using the Visual Field Analyzer Humphrey 750 Field (Carl Zeiss, USA). The thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (Cirrus Zeiss Cirrus HD-OCT, Carl Zeiss, USA). The q-q plot and Kolmogorov-Smirnov tests will be performed to test normal distribution of data. Descriptive statistics including frequency, percentages, standard deviation, median and range will be used. Other statistical test including ANOVA, Kruskal-Wallis, Chi-Square, and Fischer's exact tests will be performed. All statistical analyses will be performed in SPSS (version 20) at significance level of 0.05.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
99 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Oral prednisolone administration
Arm Type
Active Comparator
Arm Description
50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
Arm Title
Intravenous Erythropoietin injection
Arm Type
Active Comparator
Arm Description
2. 1000 units of erythropoietin every 12 hours for three days
Intervention Type
Drug
Intervention Name(s)
Oral prednisolone administration 50 mg
Intervention Description
50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
Intervention Type
Drug
Intervention Name(s)
Intravenous Erythropoietin injection
Intervention Description
1000 units of erythropoietin every 12 hours for three days
Primary Outcome Measure Information:
Title
Improvement in indices visual acuity compared to normal course of the disease
Description
Snellen visual acuity chart
Time Frame
6 months after the intervention
Title
Improvement in indices visual field
Description
Mean deviation and pattern standard deviation
Time Frame
6 months after the intervention
Title
Improvement in indices retinal nerve fiber thickness
Description
peripapillary Optical Coherence Tomography
Time Frame
6 months after the intervention
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals
Exclusion criteria:
Glaucoma or any ocular, neurologic or systemic disease affecting the vision
Abnormal laboratory test results such as ESR and CRP
History of ocular surgery
History of receiving medication for NAION
Uncontrolled systemic disease such as diabetes or hypertension
Contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression
Contraindications of erythropoietin administration, such as polycythemia
Unwillingness to participate in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Homayon Nick khah, MD
Phone
009822591616
Email
labbafi@hotmail.com
Facility Information:
Facility Name
Ophthalmic Research Center
City
Tehran
Country
Iran, Islamic Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Homayon Nikkhah, MD
Phone
009822591616
Email
labbafi@hotmail.com
12. IPD Sharing Statement
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NAION Treatment With Oral Prednisolone and Erythropoietin Injection
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