Systemic Erythropoietin Injection in Patients Having Optic Atrophy

July 11, 2021 updated by: Mohamed Fahmy Doheim, Alexandria University
The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Interventional

Enrollment (Actual)

10

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria Faculty of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Post papilledemic optic atrophy patients

Exclusion Criteria:

  • Refuse to give an informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Systemic erythropoietin injections
The study included 10 patients diagnosed as post papilledemic optic atrophy
Drug: Systemic erythropoietin injection
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
Other Names:
  • Eprax 10000

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual acuity
Time Frame: 3 months
VIsual acuity assessed at the follow up
3 months
Pattern visual evoked Potential .
Time Frame: 3 months
Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control
3 months
Pattern electroretinogram
Time Frame: 3 months
Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2020

Primary Completion (ACTUAL)

March 1, 2021

Study Completion (ACTUAL)

March 30, 2021

Study Registration Dates

First Submitted

December 15, 2020

First Submitted That Met QC Criteria

December 19, 2020

First Posted (ACTUAL)

December 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 13, 2021

Last Update Submitted That Met QC Criteria

July 11, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0304845

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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