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

NCT04469777 | Completed Phase 1

• 1 other identifier: 0304649
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Optic Neuropathy

Outcome Measures

Primary Outcomes (2)

• 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

• Flash visual-evoked potentials

  Flash VEP to detect amplitude reduction and latency in the optic nerve.

  3 months

Study Arms (1)

Systemic erythropoietin injections

EXPERIMENTAL

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

Interventions

erythropoietin DRUG

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

Systemic erythropoietin injections

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Patients with perforating ocular injuries were excluded.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Optic Nerve Diseases

Interventions

Erythropoietin

Condition Hierarchy (Ancestors)

Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

Intervention Hierarchy (Ancestors)

Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Study Officials

• Mai ElBahwash, PhD

  Alexandria Faculty of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prinicipal investigator

Model Details: 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.

Study Record Dates

• First Submitted: June 28, 2020
• First Posted: July 14, 2020
• Study Start: April 1, 2019
• Primary Completion: December 15, 2020
• Study Completion: December 30, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)