NCT03308448

Traumatic Optic Neuropathy Treatment Trial 2

Traumatic Optic Neuropathy Treatment Trial 2; Efficacy of Different Doses of Erythropoietin. A Multicenter, Double Blind RCT

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 93 (actual)
• Sponsor: Iran University of Medical Sciences · Academic / Other
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

After introducing intravenous erythropoietin (EPO) as an option for treatment of patients with indirect traumatic optic neuropathy in 2011 and publishing non inferiority trial in Oct.2017), TONTT2 is aiming to find out the best dose and timing of EPO administration in this group of patients.

Detailed description

Patients with TON will be visited. After being eligible to enter the study and obtaining informed consent, they will be randomly assigned into 3 groups of different total dose of intravenous administration of EPO to which patients and outcome assessors will be masked. They will be assessed at different follow up time periods with the last follow up of at least 3 months.

Conditions

• Traumatic Optic Neuropathy

Interventions

Type	Name	Description
DRUG	Recombinant human erythropoietin	Intravenous administration of recombinant human erythropoietin (4000 u/vial) with different dosage for each group

Timeline

• Start date: 2018-01-06
• Primary completion: 2022-08-06
• Completion: 2023-03-02
• First posted: 2017-10-12
• Last updated: 2024-03-08

Locations

3 sites across 1 country: Iran