Acute Nonarteritic Anterior Ischemic Optic NeuropathyPhase 1/2NCT01330524
Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo
A Phase 1/2 study testing Avastin and Triamcinolone in people with Acute Nonarteritic Anterior Ischemic Optic Neuropathy, run by Shahid Beheshti University of Medical Sciences at 1 site in Iran.
Trial summary
In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Nonarteritic Anterior Ischemic Optic Neuropathy
- What is being tested?
- Avastin and Triamcinolone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteIran
- Study dates
- Jan 2010to Nov 2011
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)
Who cannot join
- Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
- Neurologic defect
- Abnormal ESR, CRP, any history of retina or vitreal surgery
- Severe corneal opacity which makes retina examination impossible
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Labbafinejad medical center
Tehran
morteza entezari, Associate Professor, 00982122585952, entmort@hotmail.com
morteza entezari, associat of profesor
About this study
Official title: Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.
- Being tested
- Avastin and Triamcinolone, placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Avastin and TriamcinoloneDrug
1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal
placeboOther
2mg placebo
| Study group | Role | What they receive |
|---|---|---|
| Avastin and Triamcinolone | Active comparator | Not described Receives: Drug: Avastin and Triamcinolone |
| Placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Best corrected visual acuity(BCVA)
outcome method of measurement: Snellen chart
Measured: 6 month
Secondary outcomes (1)
Changes of Visual Field
Automated perimeter
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2011 (estimated)
- Study startJan 2010
- Primary completionNov 2010 (estimated)
- Study completionNov 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Nonarteritic Anterior Ischemic Optic NeuropathyStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shahid Beheshti University of Medical Sciences
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01330524
- Sponsor's protocol ID
- 8749
- Status last verified
- Nov 2009
- First submitted
- 8 Mar 2011
- Last updated
- 7 Apr 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intravitreal Bevacizumab and Triamcinolone With Placebo in Acute Nonarteritic Anterior Ischemic Optic Neuropathy
- ClinicalTrials.gov ID
- NCT01330524
- Acronym / sponsor ID
- 8749
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Shahid Beheshti University of Medical SciencesUniversity, hospital or other
- Study start
- Jan 2010
- Primary completion
- Nov 2010 (estimated)
- Study completion
- Nov 2011 (estimated)
- First posted
- 7 Apr 2011 (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.
In this study 16 Patients diagnosed with Nonarteritic Anterior Ischemic Optic Neuropathy(NSION) who had a sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn in less than 30 days without exclusion criteria are randomly divided in two groups 1) control 2) case. In case group Avastin and Triamcinolone will be injected trough vitreal and placebo will be injected in control group. BCVA and Visual field will be then measured in these two groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Avastin and Triamcinolone | Active comparator | Drug: Avastin and Triamcinolone |
| Placebo | Placebo comparator | Other: placebo |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Sudden mono ocular vision loss associated with optic disc edema and positive Marcus Gunn (<30 days)
Key exclusion criteria (4 listed)
- Any eye disease except NAION(Nonarteritic Anterior Ischemic Optic Neuropathy)
- Neurologic defect
- Abnormal ESR, CRP, any history of retina or vitreal surgery
- Severe corneal opacity which makes retina examination impossible
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 |
|---|---|---|
| Avastin and Triamcinolone1.25 mg Avastin and 2mg Triamcinolone will be injected trough vitreal | Drug | Avastin and Triamcinolone |
| placebo2mg placebo | Other | Placebo |
Primary outcome
Changes of Best corrected visual acuity(BCVA)
Time frame: 6 month
outcome method of measurement: Snellen chart
1 secondary outcome
Changes of Visual Field
Time frame: 6 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2011.
Related trials for Acute Nonarteritic Anterior Ischemic Optic Neuropathy
Not yet recruitingPhase 4
Emerging Indications for Hyperbaric Oxygen Treatment
Post-COVID-19 Condition, Ulcerative Colitis
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 1/2 study testing Avastin and Triamcinolone in people with Acute Nonarteritic 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 7 Apr 2011. 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 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes of Best corrected visual acuity(BCVA) (time frame: 6 month). 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 7 Apr 2011.