NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)Phase 3NAIONNCT02439866
Outcomes of Steroid and Oxygen Therapy Versus Placebo Therapy in Non-arteritic Anterior Ischemic Optic Neuropathy
A Phase 3 study testing Intravenous methylprednisolone and normobaric oxygen with face mask in people with NAION( Non-arteritic Anterior Ischemic Optic Neuropathy), run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)
- What is being tested?
- Intravenous methylprednisolone and normobaric oxygen with face mask
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIran
- Study dates
- Feb 2014to Jul 2015
- Phase
- Phase 3
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy
Who cannot join
- the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
- a history of previous ocular surgery;
- a history of prior treatment of any type for NAION;
- systemic condition such as diabetes mellitus and poorly controlled hypertension
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Study site
Tehran
mohammad pakravan, 009822591616, labbafi@hotmail.com
About this study
Official title: The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial
Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.
- Being tested
- placebo, Intravenous methylprednisolone, normobaric oxygen with face mask
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
placeboDrug
gelatinous capsules filled with sugar as placebo
Intravenous methylprednisoloneDrug
Intravenous methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day (Prednisolone Fort; Sina Daroo, Iran
normobaric oxygen with face maskDrug
normobaric oxygen100% with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks
| Study group | Role | What they receive |
|---|---|---|
| prescription placebo | Placebo comparator | control Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo Receives: Drug: placebo |
| prescription Intravenous methylprednisolone | Active comparator | Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day Receives: Drug: Intravenous methylprednisolone |
| prescription normobaric oxygen with face mask | Active comparator | Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Receives: Drug: normobaric oxygen with face mask |
What is being measured
The primary outcome is the main question the study is designed to answer.
Best corrected visual acuity using Snellen chart
Snellen chart
Measured: until 6 months
Secondary outcomes (1)
Visual field mean deviation index using the Humphrey Visual Field Analyzer
the Humphrey Visual Field Analyzer (HFA; model 750; Carl Zeiss Meditec, Inc., Dublin, California, USA)
Measured: until 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2015 (estimated)
- Study startFeb 2014
- Primary completionJul 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NAION( Non-arteritic Anterior Ischemic Optic Neuropathy)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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 90 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
- NCT02439866
- Sponsor's protocol ID
- 93222
- Acronym
- NAION
- Status last verified
- Jan 2014
- First submitted
- 7 May 2015
- Last updated
- 12 May 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of High Dose Steroid and Normobaric Oxygen Therapy on Recent Onset Non-arteritic Anterior Ischemic Optic Neuropathy(NAION); a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02439866
- Acronym / sponsor ID
- NAION / 93222
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jul 2015 (estimated)
- First posted
- 12 May 2015 (estimated)
- 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.
Patients diagnosed with NAION within 14 days of onset were included. Patients were randomized into 3 groups. Group 1 or control consisted of 30 patients who received gelatinous capsules filled with sugar as placebo. Group 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day. Thirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks Functional and structural outcomes were assessed at 1 and 6 months following treatment. Best corrected visual acuity was the main outcome measure, and mean deviation index of visual field test and peripapillary retinal nerve fiber layer thickness were secondary outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| prescription placebo | Placebo comparator | Drug: placebocontrol Group consisted of 30 patients who received gelatinous capsules filled with sugar as placebo |
| prescription Intravenous methylprednisolone | Active comparator | Drug: Intravenous methylprednisoloneGroup 2 or steroid consisted of 30 patients received methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day |
| prescription normobaric oxygen with face mask | Active comparator | Drug: normobaric oxygen with face maskThirty patients in group 3 or oxygen received 100% normobaric oxygen with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with recent onset ( within 2 weeks) of non-arteritic ischemic optic neuropathy
Key exclusion criteria (4 listed)
- the presence of glaucoma, or any other ocular, neurologic, or systemic disease that may influence visual acuity and visual field; abnormal results in laboratory assessments, including an abnormally elevated erythrocyte sedimentation rate and positive serum C-reactive protein;
- a history of previous ocular surgery;
- a history of prior treatment of any type for NAION;
- systemic condition such as diabetes mellitus and poorly controlled 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 |
|---|---|---|
| placebogelatinous capsules filled with sugar as placebo | Drug | prescription placebo |
| Intravenous methylprednisoloneIntravenous methylprednisolone (Solu-Medrol, Pharmacia Pharmaceutical Company, Belgium) 500 mg twice a day for 3 days followed by 2 weeks of oral prednisolone 1mg/kg/day (Prednisolone Fort; Sina Daroo, Iran | Drug | prescription Intravenous methylprednisolone |
| normobaric oxygen with face masknormobaric oxygen100% with face mask in sitting position, at a flow rate of 5 liters per minute for 1 hour twice a day for two weeks | Drug | prescription normobaric oxygen with face mask |
Primary outcome
Best corrected visual acuity using Snellen chart
Time frame: until 6 months
Snellen chart
1 secondary outcome
Visual field mean deviation index using the Humphrey Visual Field Analyzer
Time frame: until 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2015.
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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 3 study testing Intravenous methylprednisolone and normobaric oxygen with face mask in people with NAION( Non-arteritic Anterior Ischemic Optic Neuropathy), 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 4 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 12 May 2015. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 mohammad pakravan (009822591616, labbafi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Best corrected visual acuity using Snellen chart (time frame: until 6 months). 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 12 May 2015.