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

Sponsor

Alexandria University (Other)

Overall Status

Completed

CT.gov ID

NCT04469777

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Optic Neuropathy	Drug: erythropoietin	Phase 1/Phase 2

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

20 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital. All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.The study included 20 patients diagnosed as late onset optic neuropathy that are attending Alexandria main university hospital. All patients underwent initially assessment of visual acuity, color vision, pupil reaction ,funduscopy and electrophysiological tests ( pattern visual evoked potential and pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control). Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). Follow up after one month and three months by recording visual acuity and electro physiological studies.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Apr 1, 2019

Actual Primary Completion Date :

Dec 15, 2020

Actual Study Completion Date :

Dec 30, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Systemic erythropoietin injections 20 patients diagnosed as late onset optic neuropathy that were attending Alexandria main university hospital.Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).	Drug: erythropoietin Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Arm

Intervention/Treatment

Experimental: Systemic erythropoietin injections

20 patients diagnosed as late onset optic neuropathy that were attending Alexandria main university hospital.Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).

Drug: erythropoietin

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

Outcome Measures

Primary Outcome Measures

Assessment of visual acuity [3 months]
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
Flash visual-evoked potentials [3 months]
Flash VEP to detect amplitude reduction and latency in the optic nerve.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alexandria Faculty of Medicine	Alexandria		Egypt

Sponsors and Collaborators

Alexandria University

Investigators

Principal Investigator: Mai ElBahwash, PhD, Alexandria Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mohamed Fahmy Doheim, Prinicipal investigator, Alexandria University

ClinicalTrials.gov Identifier:

NCT04469777

Other Study ID Numbers:

0304649

First Posted:

Jul 14, 2020

Last Update Posted:

Apr 1, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Optic Nerve Diseases

Epoetin Alfa

Study Results

No Results Posted as of Apr 1, 2021