Systemic Erythropoietin Injection in Patients Having Optic Atrophy

NCT04680143 | Completed Phase 1

• 1 other identifier: 0304845
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.

Conditions

Optic Atrophy

Outcome Measures

Primary Outcomes (3)

• Visual acuity

  VIsual acuity assessed at the follow up

  3 months

• Pattern visual evoked Potential .

  Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control

  3 months

• Pattern electroretinogram

  Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control

  3 months

Study Arms (1)

Systemic erythropoietin injections

EXPERIMENTAL

The study included 10 patients diagnosed as post papilledemic optic atrophy

Drug: Systemic erythropoietin injection

Interventions

Systemic erythropoietin injection DRUG

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

Also known as: Eprax 10000

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:

• Post papilledemic optic atrophy patients

You may not qualify if:

• Refuse to give an informed consent

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria Faculty of Medicine

Alexandria, Egypt

Location

MeSH Terms

Conditions

Optic Atrophy

Condition Hierarchy (Ancestors)

Optic Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Eye Diseases

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 10 patients diagnosed as post papilledemic optic atrophy that were 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: December 15, 2020
• First Posted: December 22, 2020
• Study Start: September 1, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 30, 2021
• Last Updated: July 13, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)