Back to resultsSubcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Primary Purpose
Optic Neuropathy
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
erythropoietin
Sponsored by
About this trial
This is an interventional treatment trial for Optic Neuropathy
Eligibility Criteria
Inclusion Criteria:
- Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)
Exclusion Criteria:
- Patients with perforating ocular injuries were excluded.
Sites / Locations
- Alexandria Faculty of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systemic erythropoietin injections
Arm Description
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).
Outcomes
Primary Outcome Measures
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
Flash visual-evoked potentials
Flash VEP to detect amplitude reduction and latency in the optic nerve.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04469777
Brief Title
Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Official Title
Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
December 15, 2020 (Actual)
Study Completion Date
December 30, 2020 (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
This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.
Detailed Description
Injury of the optic nerve or optic neuropathy is one of the most common causes of vision loss. This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Optic Neuropathy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Systemic erythropoietin injections
Arm Type
Experimental
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
erythropoietin
Intervention Description
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
Primary Outcome Measure Information:
Title
Assessment of visual acuity
Description
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
Time Frame
3 months
Title
Flash visual-evoked potentials
Description
Flash VEP to detect amplitude reduction and latency in the optic nerve.
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:
Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)
Exclusion Criteria:
Patients with perforating ocular injuries were excluded.
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
Learn more about this trial
Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
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