NAION Treatment With Oral Prednisolone and Erythropoietin Injection

NCT03715881 | Unknown Phase 2

• 1 other identifier: 95275
• Study Type: interventional
• Target: 99
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Oral prednisolone administration

ACTIVE COMPARATOR

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

Intravenous Erythropoietin injection

ACTIVE COMPARATOR

2\. 1000 units of erythropoietin every 12 hours for three days

Drug: Intravenous Erythropoietin injection

Interventions

Oral prednisolone administration 50 mg DRUG

50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued

Oral prednisolone administration

Intravenous Erythropoietin injection DRUG

1000 units of erythropoietin every 12 hours for three days

Intravenous Erythropoietin injection

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• \- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals

You may not qualify if:

• 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

Sponsors & Collaborators

• Shahid Beheshti University of Medical Sciences: lead

Study Sites (1)

Ophthalmic Research Center

Tehran, Iran

RECRUITING

Central Study Contacts

Homayon Nick khah, MD

CONTACT

009822591616; labbafi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 12, 2018
• First Posted: October 23, 2018
• Study Start: December 1, 2018
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: October 23, 2018

Record last verified: 2018-06

Locations

IR (1)