NCT03715881: NAION

NAION Treatment With Oral Prednisolone and Erythropoietin Injection

Status unknown Phase 2 Last updated 23 October 2018

What this trial tests

Phase 2 trial testing Oral prednisolone administration 50 mg in Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) in 99 participants. Status unknown.

Timeline

1 December 2018

Primary endpoint
1 December 2018

1 March 2019

Quick facts

Lead sponsor	Shahid Beheshti University of Medical Sciences
Phase	Phase 2
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	99
Start date	1 December 2018
Primary completion	1 December 2018
Estimated completion	1 March 2019
Sites	1 location across Iran

Drugs / interventions tested

• Oral prednisolone administration 50 mg — full drug profile →
• Intravenous Erythropoietin injection — full drug profile →

Conditions studied

• Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) — all drugs for Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION) →

Sponsor

Shahid Beheshti University of Medical Sciences

Who can join

Eligibility, any sex, with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION). Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Neuroprotective Strategies for Retinal Ganglion Cell Degeneration: Current Status and Challenges Ahead.
   Boia R, Ruzafa N, Aires ID, Pereiro X, et al · · 2020 · cited 84× · PMID 32218163 · DOI 10.3390/ijms21072262
2. Neuro-protection and neuro-regeneration of the optic nerve: recent advances and future directions.
   Gokoffski KK, Peng M, Alas B, Lam P. · · 2020 · cited 45× · PMID 31809331 · DOI 10.1097/wco.0000000000000777