Optic NeuropathyPhase 1/2NCT04469777
Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
A Phase 1/2 study testing erythropoietin in people with Optic Neuropathy, run by Alexandria University at 1 site in Egypt.
Trial summary
This study aimed to investigate the therapeutic effect of subcutaneous erythropoietin in the management of late stage optic neuropathy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Optic Neuropathy
- What is being tested?
- erythropoietin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2019to 30 Dec 2020
- 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
- Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)
Who cannot join
- Patients with perforating ocular injuries were excluded.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
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.
- Conditions
- Optic Neuropathy
- Being tested
- erythropoietin
- Medical subject headings
- Optic Nerve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erythropoietinDrug
Systemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days).
| Study group | Role | What they receive |
|---|---|---|
| Systemic erythropoietin injections | Experimental | 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). Receives: Drug: erythropoietin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 months
Flash visual-evoked potentials
Flash VEP to detect amplitude reduction and latency in the optic nerve.
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 posted14 Jul 2020
- Study start1 Apr 2019
- Primary completion15 Dec 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuropathyStudies 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 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)
- Enrolment
- 20 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
- NCT04469777
- Sponsor's protocol ID
- 0304649
- Status last verified
- Mar 2021
- First submitted
- 28 Jun 2020
- Last updated
- 1 Apr 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 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Subcutaneous Injection of Erythropoietin on Visual Functions in Patients With Late Onset Optic Neuropathy
- ClinicalTrials.gov ID
- NCT04469777
- Acronym / sponsor ID
- 0304649
- Conditions
- Optic Neuropathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 1 Apr 2019 (actual)
- Primary completion
- 15 Dec 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 14 Jul 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.
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.
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 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.
| Arm | Type | Receives |
|---|---|---|
| Systemic erythropoietin injections | Experimental | Drug: erythropoietin20 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with late stage optic neuropathy (1 month to 12 months after onset of optic neuropathy due to late referral of the cases)
Key exclusion criteria (1 listed)
- Patients with perforating ocular injuries were excluded.
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 |
|---|---|---|
| erythropoietinSystemic erythropoietin injections (eprax 10000 IU subcutaneous twice daily for three days). | Drug | Systemic erythropoietin injections |
Primary outcome
Assessment of visual acuity
Time frame: 3 months
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
Time frame: 3 months
Flash VEP to detect amplitude reduction and latency in the optic nerve.
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 1 Apr 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 erythropoietin in people with Optic Neuropathy, 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 1 Apr 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?
Assessment of visual acuity (time frame: 3 months). The study lists 2 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 1 Apr 2021.