NAION Treatment With Oral Prednisolone and Erythropoietin Injection (NAION)

Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

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.

Study Overview

• Status: Unknown
• Conditions: Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
• Intervention / Treatment: Drug: Oral prednisolone administration 50 mg; Drug: Intravenous Erythropoietin injection

• Study Type: Interventional
• Enrollment (Anticipated): 99
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Homayon Nick khah, MD; Phone Number: 009822591616; Email: labbafi@hotmail.com

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Recruiting
    • Ophthalmic Research Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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:

1. Glaucoma or any ocular, neurologic or systemic disease affecting the vision
2. Abnormal laboratory test results such as ESR and CRP
3. History of ocular surgery
4. History of receiving medication for NAION
5. Uncontrolled systemic disease such as diabetes or hypertension
6. Contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression
7. Contraindications of erythropoietin administration, such as polycythemia
8. Unwillingness to participate in the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Oral prednisolone administration; 50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued	Drug: Oral prednisolone administration 50 mg; 50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
Active Comparator: Intravenous Erythropoietin injection; 2. 1000 units of erythropoietin every 12 hours for three days	Drug: Intravenous Erythropoietin injection; 1000 units of erythropoietin every 12 hours for three days

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in indices visual acuity compared to normal course of the disease	Snellen visual acuity chart	6 months after the intervention
Improvement in indices visual field	Mean deviation and pattern standard deviation	6 months after the intervention
Improvement in indices retinal nerve fiber thickness	peripapillary Optical Coherence Tomography	6 months after the intervention

Collaborators and Investigators

• Sponsor: Shahid Beheshti University of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2018
• Primary Completion (Anticipated): December 1, 2018
• Study Completion (Anticipated): March 1, 2019

Study Registration Dates

• First Submitted: June 12, 2018
• First Submitted That Met QC Criteria: October 22, 2018
• First Posted (Actual): October 23, 2018

Study Record Updates

• Last Update Posted (Actual): October 23, 2018
• Last Update Submitted That Met QC Criteria: October 22, 2018
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Nervous System Diseases; Eye Diseases; Cranial Nerve Diseases; Optic Nerve Diseases; Optic Neuropathy, Ischemic; Physiological Effects of Drugs; Anti-Inflammatory Agents; Antineoplastic Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hematinics; Prednisolone; Epoetin Alfa
• Other Study ID Numbers: 95275

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No