Back to resultsSystemic Erythropoietin Injection in Patients Having Optic Atrophy
Primary Purpose
Optic Atrophy
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Systemic erythropoietin injection
Sponsored by
About this trial
This is an interventional treatment trial for Optic Atrophy
Eligibility Criteria
Inclusion Criteria:
- Post papilledemic optic atrophy patients
Exclusion Criteria:
- Refuse to give an informed consent
Sites / Locations
- Alexandria Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systemic erythropoietin injections
Arm Description
The study included 10 patients diagnosed as post papilledemic optic atrophy
Outcomes
Primary Outcome Measures
Visual acuity
VIsual acuity assessed at the follow up
Pattern visual evoked Potential .
Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control
Pattern electroretinogram
Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04680143
Brief Title
Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Official Title
Systemic Erythropoietin Injection in Patients Having Optic Atrophy
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
March 1, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Atrophy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic erythropoietin injections
Arm Type
Experimental
Arm Description
The study included 10 patients diagnosed as post papilledemic optic atrophy
Intervention Type
Drug
Intervention Name(s)
Systemic erythropoietin injection
Other Intervention Name(s)
Eprax 10000
Intervention Description
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
Primary Outcome Measure Information:
Title
Visual acuity
Description
VIsual acuity assessed at the follow up
Time Frame
3 months
Title
Pattern visual evoked Potential .
Description
Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control
Time Frame
3 months
Title
Pattern electroretinogram
Description
Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Post papilledemic optic atrophy patients
Exclusion Criteria:
Refuse to give an informed consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mai ElBahwash, PhD
Organizational Affiliation
Alexandria Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria Faculty of Medicine
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
No
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Systemic Erythropoietin Injection in Patients Having Optic Atrophy
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