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Systemic Erythropoietin Injection in Patients Having Optic Atrophy

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT04680143
Collaborator
(none)
10
Enrollment
1
Location
1
Arm
6.9
Actual Duration (Months)
1.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: Systemic erythropoietin injection
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
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.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.
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Actual Study Start Date :
Sep 1, 2020
Actual Primary Completion Date :
Mar 1, 2021
Actual Study Completion Date :
Mar 30, 2021

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Visual acuity [3 months]

      VIsual acuity assessed at the follow up

    2. Pattern visual evoked Potential . [3 months]

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

    3. Pattern electroretinogram [3 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Post papilledemic optic atrophy patients
    Exclusion Criteria:
    • Refuse to give an informed consent

    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:
    NCT04680143
    Other Study ID Numbers:
    • 0304845
    First Posted:
    Dec 22, 2020
    Last Update Posted:
    Jul 13, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Optic Atrophy
    Atrophy
    Epoetin Alfa

    Study Results

    No Results Posted as of Jul 13, 2021