Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy

Optic Neuropathy Clinical Trial

Official title:

Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04469777
• Other study ID #: 0304649
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 1, 2019
• Est. completion date: December 30, 2020

Study information

• Verified date: March 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Description:

Injury of the optic nerve or optic neuropathy is one of the most common causes of vision loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 30, 2020
• Est. primary completion date: December 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)

Exclusion Criteria:

• Patients with perforating ocular injuries were excluded.

Related Conditions & MeSH terms

• Optic Nerve Diseases
• Optic Neuropathy

Intervention

Drug:
• erythropoietin
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Locations

Country	Name	City	State
Egypt	Alexandria Faculty of Medicine	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of visual acuity	Visual acuity using appropriate charts for assessment then convert into log of the minimum angle of resolution (logMAR) units to provide a numeric scale of visual acuity	3 months
Primary	Flash visual-evoked potentials	Flash VEP to detect amplitude reduction and latency in the optic nerve.	3 months