Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)Phase 2NAIONNCT03715881
NAION Treatment With Oral Prednisolone and Erythropoietin Injection
A Phase 2 study testing Oral prednisolone administration 50 mg and Intravenous Erythropoietin injection in people with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
This randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
- What is being tested?
- Oral prednisolone administration 50 mg and Intravenous Erythropoietin injection
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteIran
- Study dates
- 1 Dec 2018to 1 Mar 2019
- Phase
- Phase 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals
Who cannot join
- Glaucoma or any ocular, neurologic or systemic disease affecting the vision
- Abnormal laboratory test results such as ESR and CRP
- History of ocular surgery
- History of receiving medication for NAION
- Uncontrolled systemic disease such as diabetes or hypertension
- Contraindications of systemic steroids including active infection, active gastric ulcer, immunosuppression
- Contraindications of erythropoietin administration, such as polycythemia
- Unwillingness to participate in the study
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Ophthalmic Research Center
Tehran
Homayon Nikkhah, MD, 009822591616, labbafi@hotmail.com
About this study
Official title: Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
This randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. The first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. The second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. In addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. The third group will receive placebo. Eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. SITA standard visual field testing will be done using the Visual Field Analyzer Humphrey 750 Field (Carl Zeiss, USA). The thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (Cirrus Zeiss Cirrus HD-OCT, Carl Zeiss, USA). The q-q plot and Kolmogorov-Smirnov tests will be performed to test normal distribution of data. Descriptive statistics including frequency, percentages, standard deviation, median and range will be used. Other statistical test including ANOVA, Kruskal-Wallis, Chi-Square, and Fischer's exact tests will be performed. All statistical analyses will be performed in SPSS (version 20) at significance level of 0.05.
- Being tested
- Oral prednisolone administration 50 mg, Intravenous Erythropoietin injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral prednisolone administration 50 mgDrug
50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued
Intravenous Erythropoietin injectionDrug
1000 units of erythropoietin every 12 hours for three days
| Study group | Role | What they receive |
|---|---|---|
| Oral prednisolone administration | Active comparator | 50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued Receives: Drug: Oral prednisolone administration 50 mg |
| Intravenous Erythropoietin injection | Active comparator | 2. 1000 units of erythropoietin every 12 hours for three days Receives: Drug: Intravenous Erythropoietin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in indices visual acuity compared to normal course of the disease
Snellen visual acuity chart
Measured: 6 months after the intervention
Improvement in indices visual field
Mean deviation and pattern standard deviation
Measured: 6 months after the intervention
Improvement in indices retinal nerve fiber thickness
peripapillary Optical Coherence Tomography
Measured: 6 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2018
- Study start1 Dec 2018 (estimated)
- Primary completion1 Dec 2018 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)Studies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 99 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zahra Rabbani Khah, Shahid Beheshti University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03715881
- Sponsor's protocol ID
- 95275
- Acronym
- NAION
- Status last verified
- Jun 2018
- First submitted
- 12 Jun 2018
- Last updated
- 23 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scientific Title: Efficacy of Oral Prednisolone and Erythropoietin Injection in Treatment of Acute Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION)
- ClinicalTrials.gov ID
- NCT03715881
- Acronym / sponsor ID
- NAION / 95275
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 99 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- 1 Dec 2018 (estimated)
- Primary completion
- 1 Dec 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 23 Oct 2018 (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 randomized double-blind clinical trial is performed on all recent (within the last 5 days) NAION patients referred to hospitals affiliated to the Shahid Beheshti University of Medical Sciences, Iran. The patients will be equally and randomly assigned into two experimental groups and a control group. The first experimental group will receive 1000 units of erythropoietin every 12 hours for three days. The second experimental group will receive 50 mg of oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued. In addition, the subjects in the second experimental group will receive 300 mg of ranitidine daily. The third group will receive placebo. Eye examination with color vision, perimetry, and peripapillary optical coherence tomography (to measure the thickness of the retinal nerve fiber layer) will be performed before the intervention, and 1, 3 and 6 months after the intervention. SITA standard visual field testing will be done using the Visual Field Analyzer Humphrey 750 Field (Carl Zeiss, USA). The thickness of the retinal nerve fiber layer will be measured by optical coherence tomography (Cirrus Zeiss Cirrus HD-OCT, Carl Zeiss, USA). The q-q plot and Kolmogorov-Smirnov tests will be performed to test normal distribution of data. Descriptive statistics including frequency, percentages, standard deviation, median and range will be used. Other statistical test including ANOVA, Kruskal-Wallis, Chi-Square, and Fischer's exact tests will be performed. All statistical analyses will be performed in SPSS (version 20) at significance level of 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral prednisolone administration | Active comparator | Drug: Oral prednisolone administration 50 mg50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued |
| Intravenous Erythropoietin injection | Active comparator | Drug: Intravenous Erythropoietin injection2. 1000 units of erythropoietin every 12 hours for three days |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All NAION patients (maximum time of disease occurrence: 5 days) referred to emergency department of Labbafinejad, Torfeh and Imam Hossein hospitals
Key exclusion criteria (8 listed)
- Glaucoma or any ocular, neurologic or systemic disease affecting the vision
- Abnormal laboratory test results such as ESR and CRP
- History of ocular surgery
- History of receiving medication for NAION
- Uncontrolled systemic disease such as diabetes or hypertension
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 |
|---|---|---|
| Oral prednisolone administration 50 mg50 mg oral prednisolone from the onset of the disease for 1 week, with the dose gradually reduced within 2 weeks and then discontinued | Drug | Oral prednisolone administration |
| Intravenous Erythropoietin injection1000 units of erythropoietin every 12 hours for three days | Drug | Intravenous Erythropoietin injection |
Primary outcome
Improvement in indices visual acuity compared to normal course of the disease
Time frame: 6 months after the intervention
Snellen visual acuity chart
Improvement in indices visual field
Time frame: 6 months after the intervention
Mean deviation and pattern standard deviation
Improvement in indices retinal nerve fiber thickness
Time frame: 6 months after the intervention
peripapillary Optical Coherence Tomography
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2018.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Oral prednisolone administration 50 mg and Intravenous Erythropoietin injection in people with Non-Arteritic Anterior Ischemic Optic Neuropathy (NAION), run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
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 8 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: status not confirmed, as of the sponsor's last update on 23 Oct 2018. 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 Iran. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Homayon Nick khah, MD (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in indices visual acuity compared to normal course of the disease (time frame: 6 months after the intervention). 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 23 Oct 2018.