ClinicalTrials.gg
CompletedNCT04680143Updated Jul 13, 2021

Systemic Erythropoietin Injection in Patients Having Optic Atrophy

A Phase 1/2 interventional study of Systemic erythropoietin injection in Optic Atrophy, sponsored by Alexandria University. Completed at 1 site in Egypt. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2021-07-13.

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

From the registry’s dates

  • Registered 3 months after the study started (first participant enrolled Sep 2020, registered Dec 2020).
Phase
Phase 1/2
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 80 Years
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Optic Atrophy

Browse trials for

03

In context

Optic Atrophy

16 studies on the registry are indexed under Optic Atrophy; 3 are open to participants now.

This study's enrollment of 10 is below the median of 23 across 10 interventional studies indexed under Optic Atrophy.

Browse Optic Atrophy studies →

Lead sponsor

Alexandria University is the lead sponsor of 604 studies on the registry; 140 are open to participants now.

Of its 13 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

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

04

Who can participate

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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Post papilledemic optic atrophy patients

Exclusion criteria

Exclusion Criteria:

  • Refuse to give an
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

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

Study arms

  • Experimental
    Systemic erythropoietin injections

    The study included 10 patients diagnosed as post papilledemic optic atrophy

    Drug: Systemic erythropoietin injection

Interventions

  • DrugSystemic erythropoietin injection

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

    Also known as: Eprax 10000

06

What researchers measure

Primary outcomes

  1. Visual acuity

    VIsual acuity assessed at the follow up

    Time frame: 3 months

  2. Pattern visual evoked Potential .

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

    Time frame: 3 months

  3. Pattern electroretinogram

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

    Time frame: 3 months

07

Study locations

1 site
  • Alexandria Faculty of Medicine
    Alexandria, Egypt
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Sep 2020 to primary completion in Mar 2021, 6 months.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 15, 2020
First posted
Dec 22, 2020
StartActual
Sep 1, 2020
Primary completionActual
Mar 1, 2021
CompletionActual
Mar 30, 2021
Last update
Jul 13, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 13, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04680143
Responsible party
Mohamed Fahmy Doheim (Prinicipal investigator, Alexandria University) — Principal investigator
First posted
Dec 22, 2020
Start date
Sep 1, 2020
Primary completion
Mar 1, 2021
Completion
Mar 30, 2021
Last update
Jul 13, 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 Jul 2021. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion