NAION Treatment With Oral Prednisolone and Erythropoietin Injection

NCT ID: NCT03715881

Last Updated: 2018-10-23

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 99 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-12-01
• Study Completion Date: 2019-03-01

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Oral prednisolone administration 50 mg

Intervention Type: 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

Intravenous Erythropoietin injection

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

Group Type: ACTIVE_COMPARATOR

Intravenous Erythropoietin injection

Intervention Type: DRUG

1000 units of erythropoietin every 12 hours for three days

Interventions

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

Intervention Type: DRUG

Intravenous Erythropoietin injection

1000 units of erythropoietin every 12 hours for three days

Intervention Type: DRUG

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

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Shahid Beheshti University of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Zahra Rabbani Khah

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ophthalmic Research Center

Tehran, , Iran

Site Status: RECRUITING

Countries

Iran

Central Contacts

Homayon Nick khah, MD

Role: CONTACT

labbafi@hotmail.com

009822591616

Facility Contacts

Homayon Nikkhah, MD

Role: primary

labbafi@hotmail.com

009822591616

Other Identifiers

95275

Identifier Type: -

Identifier Source: org_study_id