Optic NeuritisNCT02886377
The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset
An observational study of Optic Neuritis, run by Xiujuan Zhao at 1 site in China.
Trial summary
To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- blood test of anti-AQP4 antibody
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Nov 2013to Dec 2016
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: 250
Who may be able to join
- Optic neuritis patients
Who cannot join
- The presence of significant refractive errors (3D of spherical equivalent refraction or 2D of astigmatism), intraocular pressure of 21 mmHg or higher, systemic conditions that could affect the visual system, and a history of ocular trauma or concomitant ocular diseases, including a history of media opacification, ocular pathologies affecting the cornea, lens, retinal disease, glaucoma, or laser therapy. All patients in the study groups had an episode of ON more than six months before the study inclusion time point.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Ophthalmic Center
Guangzhou, Guangdong, 510060
hui Yang, PHD, +8613710584767
中国, +8613710584767
About this study
To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.
Read the detailed description
Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to the results of the AQP4-Ab test. All patients with complete medical histories underwent routine neurological examinations, brain MRIs, and ophthalmological examinations, including best corrected visual acuity (BCVA), intraocular pressure, slit lamp and fundus examination, VF and VEP, laboratory testing, including blood routine, HIV HBV HCV Syphilis, mitochondrial DNA sequencing, and a profile of autoantibodies, including antinuclear antibody (ANA), extractable nuclear antigen antibodies (SSA/SSB), rheumatoid factor (RF), anticardiolipin antibodies (ACA), and antithyroglobulin antibody.
- Conditions
- Optic Neuritis
- Being tested
- blood test of anti-AQP4 antibody
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood test of anti-AQP4 antibodyBiological
Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab.
| Study group | Role | What they receive |
|---|---|---|
| NMOSD-ON | NMOSD-ON included patients who met the established diagnostic criteria for NMO or NMOSD published by Wingerchuk et al,with AQP4 seropositive according to the results of the AQP4-Ab test. Receives: Biological: blood test of anti-AQP4 antibody | |
| MS-ON | MS-ON group patients included typical acute demyelinating ON with brain lesions fulfilling the revised McDonald criteria or clinical isolate syndrome (CIS), with AQP4 seronegative according to the results of the AQP4-Ab test. Receives: Biological: blood test of anti-AQP4 antibody | |
| Healthy controls | Age- and gender- matched healthy controls. Receives: Biological: blood test of anti-AQP4 antibody |
What is being measured
The primary outcome is the main question the study is designed to answer.
retinal nerve fiber layer thickness
Measured: 2013.11-2016.12
Secondary outcomes (2)
visual field
Measured: 2013.11-2016.12
visual evoked potential
Measured: 2013.11-2016.12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2016 (estimated)
- Study startNov 2013
- Primary completionAug 2016
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Optic NeuritisStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xiujuan Zhao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xiujuan Zhao, Zhongshan Ophthalmic Center, Sun Yat-sen University
- Investigators
- Hui Yang, Study director, World Health Organization
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02886377
- Sponsor's protocol ID
- 2014meky049
- Status last verified
- Aug 2016
- First submitted
- 7 Aug 2016
- Last updated
- 1 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Correlation Between AQP-4 Ab and the Visual Function of Patients With Demyelinating ON at Onset
- ClinicalTrials.gov ID
- NCT02886377
- Acronym / sponsor ID
- 2014meky049
- Conditions
- Optic Neuritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Xiujuan ZhaoUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 1 Sep 2016 (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.
To evaluate the optical coherence tomography (OCT), visual field (VF), Visual evoked po-tential(VEP) characteristics between neuromyelitis optica- related optic neuritis (NMOSD-ON) and multiple sclerosis- related ON (MS-ON) in a Chinese cohort.
Detailed description
Patients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to the results of the AQP4-Ab test. All patients with complete medical histories underwent routine neurological examinations, brain MRIs, and ophthalmological examinations, including best corrected visual acuity (BCVA), intraocular pressure, slit lamp and fundus examination, VF and VEP, laboratory testing, including blood routine, HIV HBV HCV Syphilis, mitochondrial DNA sequencing, and a profile of autoantibodies, including antinuclear antibody (ANA), extractable nuclear antigen antibodies (SSA/SSB), rheumatoid factor (RF), anticardiolipin antibodies (ACA), and antithyroglobulin antibody.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NMOSD-ON | – | Biological: blood test of anti-AQP4 antibodyNMOSD-ON included patients who met the established diagnostic criteria for NMO or NMOSD published by Wingerchuk et al,with AQP4 seropositive according to the results of the AQP4-Ab test. |
| MS-ON | – | Biological: blood test of anti-AQP4 antibodyMS-ON group patients included typical acute demyelinating ON with brain lesions fulfilling the revised McDonald criteria or clinical isolate syndrome (CIS), with AQP4 seronegative according to the results of the AQP4-Ab test. |
| Healthy controls | – | Biological: blood test of anti-AQP4 antibodyAge- and gender- matched healthy controls. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- 250
Key inclusion criteria (1 listed)
- Optic neuritis patients
Key exclusion criteria (1 listed)
- The presence of significant refractive errors (3D of spherical equivalent refraction or 2D of astigmatism), intraocular pressure of 21 mmHg or higher, systemic conditions that could affect the visual system, and a history of ocular trauma or concomitant ocular diseases, including a history of media opacification, ocular pathologies affecting the cornea, lens, retinal disease, glaucoma, or laser therapy. All patients in the study groups had an episode of ON more than six months before the study inclusion time point.
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 |
|---|---|---|
| blood test of anti-AQP4 antibodyPatients were sub-divided into an AQP4 seropositive group and an AQP4 seronegative group, according to blood test of the AQP4-Ab. | Biological | Healthy controls, MS-ON, NMOSD-ON |
Primary outcome
retinal nerve fiber layer thickness
Time frame: 2013.11-2016.12
2 secondary outcomes
visual field
Time frame: 2013.11-2016.12
visual evoked potential
Time frame: 2013.11-2016.12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2016.
- Individual participant dataSharing planned: Undecided
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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.
Hui Yang study director
World Health Organization
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Optic Neuritis, run by Xiujuan Zhao at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 1 Sep 2016. 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 China. 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.
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 Jian Zhang (020-87334687, zoccrc@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retinal nerve fiber layer thickness (time frame: 2013.11-2016.12). 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 Sep 2016.