Optic AtrophyPhase 1/2NCT04680143
Systemic Erythropoietin Injection in Patients Having Optic Atrophy
A Phase 1/2 study testing Systemic erythropoietin injection in people with Optic Atrophy, run by Alexandria University at 1 site in Egypt.
Trial summary
The purpose of this treatment trial is to study the effect of systemic erythropoietin in patients having optic atrophy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Optic Atrophy
- What is being tested?
- Systemic erythropoietin injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Sep 2020to 30 Mar 2021
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Post papilledemic optic atrophy patients
Who cannot join
- Refuse to give an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Optic Atrophy
- Being tested
- Systemic erythropoietin injection
- Medical subject headings
- Optic Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systemic erythropoietin injectionDrug
Also called Eprax 10000
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
| Study group | Role | What they receive |
|---|---|---|
| Systemic erythropoietin injections | Experimental | The study included 10 patients diagnosed as post papilledemic optic atrophy Receives: Drug: Systemic erythropoietin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual acuity
VIsual acuity assessed at the follow up
Measured: 3 months
Pattern visual evoked Potential .
Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control
Measured: 3 months
Pattern electroretinogram
Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2020
- Study start1 Sep 2020
- Primary completion1 Mar 2021
- Study completion30 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic AtrophyStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Fahmy Doheim, Alexandria University
- Investigators
- Mai ElBahwash, PhD, Principal investigator, Alexandria Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04680143
- Sponsor's protocol ID
- 0304845
- Status last verified
- Jul 2021
- First submitted
- 15 Dec 2020
- Last updated
- 13 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Erythropoietin Injection in Patients Having Optic Atrophy
- ClinicalTrials.gov ID
- NCT04680143
- Acronym / sponsor ID
- 0304845
- Conditions
- Optic Atrophy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Sep 2020 (actual)
- Primary completion
- 1 Mar 2021 (actual)
- Study completion
- 30 Mar 2021 (actual)
- First posted
- 22 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Systemic erythropoietin injections | Experimental | Drug: Systemic erythropoietin injectionThe study included 10 patients diagnosed as post papilledemic optic atrophy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Post papilledemic optic atrophy patients
Key exclusion criteria (1 listed)
- Refuse to give an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systemic erythropoietin injectionAlso: Eprax 10000Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). | Drug | Systemic erythropoietin injections |
Primary outcome
Visual acuity
Time frame: 3 months
VIsual acuity assessed at the follow up
Pattern visual evoked Potential .
Time frame: 3 months
Pattern visual evoked Potential .in both eyes to use data of the normal fellow eye as patients' internal control
Pattern electroretinogram
Time frame: 3 months
Pattern electroretinogram in both eyes to use data of the normal fellow eye as patients' internal control
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mai ElBahwash, PhD principal investigator
Alexandria Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Systemic erythropoietin injection in people with Optic Atrophy, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual acuity (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2021.