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CompletedNCT04469777Updated Apr 1, 2021

Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy

A Phase 1/2 interventional study of erythropoietin in Optic Neuropathy, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-04-01.

Sponsored by Alexandria University · Phase 1/2, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 2 months after the study started (first participant enrolled Apr 2019, registered Jun 2020).
Phase
Phase 1/2
Study type
Interventional
Enrollment
20
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
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Study summary

This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy.

Read the 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.

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Conditions studied

  • Optic Neuropathy

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03

In context

Optic Nerve Diseases

128 studies on the registry are indexed under Optic Nerve Diseases; 27 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 84 interventional studies indexed under Optic Nerve Diseases.

Browse Optic Nerve Diseases studies →

Lead sponsor

Alexandria University is the lead sponsor of 569 studies on the registry; 125 are open to participants now.

Of its 12 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Patients with perforating ocular injuries were excluded.
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Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
20 participants (actual)

Study arms

  • Experimental
    Systemic erythropoietin injections

    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).

    Drug: erythropoietin

Interventions

  • Drugerythropoietin

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

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What researchers measure

Primary outcomes

  1. 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

    Time frame: 3 months

  2. Flash visual-evoked potentials

    Flash VEP to detect amplitude reduction and latency in the optic nerve.

    Time frame: 3 months

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Study locations

1 site
  • Alexandria Faculty of Medicine
    Alexandria, Egypt
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04469777
Lead sponsor
Alexandria University
Responsible party
Mohamed Fahmy Doheim (Prinicipal investigator, Alexandria University) — Principal investigator
First posted
Jul 14, 2020
Start date
Apr 1, 2019
Primary completion
Dec 15, 2020
Completion
Dec 30, 2020
Last update
Apr 1, 2021

Study contacts

Mai ElBahwash, PhD
principal investigator · Alexandria Faculty of Medicine

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2021. You cannot join it, but the record below documents what was studied.

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