Optic NeuritisNCT04257734
Epidemiologic and Clinical Characteristics of Optic Neuritis in China
An observational study of Optic Neuritis, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Optic Neuritis
- What is being tested?
- observation
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2020to 30 Jun 2021
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Optic neuritis patients with complete medical records in multicenter from China.
Who may be able to join
- Clinical diagnosis of optic neuritis
- The patients' medical records were complete
Who cannot join
- Patients with unclear diagnosis of optic neuritis
- Incomplete medical records
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100835
Mo Yang, PhD, +86-183-1009-8349, doctoryangmo@icloud.com
About this study
This will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.
Read the detailed description
This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups.
Primary outcomes:
- To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;
- To calculate the annual relapse rate (ARR) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group).
Secondary outcomes:
- Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups;
- Orbital or Brain MRI is required in this study, which could avoid the misdiagnosis. We will collect and analyze these MRI data too (including the optic nerve lesions in T2 weight images and T1 enhanced MRI);
- Results of optical coherence tomography (OCT) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. However, OCT is not necessarily required;
- Visual fields at different time points are also encouraged to provide if they are available.
- Conditions
- Optic Neuritis
- Being tested
- observation
- Keywords
- optic neuritis, clinical Characteristics, epidemiology
- Medical subject headings
- Optic Neuritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observationOther
different serum antibodies status
| Study group | Role | What they receive |
|---|---|---|
| optic neuritis | Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients Receives: Other: observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Acuity
Last visual acuity records in the hospital
Measured: At least 1 year from the attack to the final visit
Annual Relapse Rate
Calculated annual relapse rate of different subgroups in the cohort
Measured: At least 1 year from the attack to the final visit
Secondary outcomes (4)
Epidemiologic characteristics of optic neuritis
Gender, age of first attack, location
Measured: At least 1 year from the attack to the final visit
Clinical characteristics of optic neuritis
Visual acuity at nadir, pain, optic disc edema
Measured: At least 1 year from the attack to the final visit
Optical Coherence Tomography
RNFL, macular thickness and GCIPL at different time points
Measured: At least 1 year from the attack to the final visit
Orbit or Brain MRI at the attack
Lesions of the optic nerve
Measured: At least 1 year from the attack to the final visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start1 May 2020
- Primary completion3 Dec 2020
- Study completion30 Jun 2021 (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.
- More trials run by Chinese PLA General HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Health Science Center
- Responsible party
- Principal investigator, Wei Shihui, Chinese PLA General Hospital
- Investigators
- Shihui Wei, M.D, Study chair, Ophthalmology, the Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04257734
- Sponsor's protocol ID
- CONSG1
- Status last verified
- Jan 2021
- First submitted
- 4 Feb 2020
- Last updated
- 20 Jan 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is a multi center study of optic neuritis, the individual participant data belongs to every single center. Now, we are applying for the approval. However, the details will not be available until all the centers approved.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Epidemiologic and Clinical Characteristics of Optic Neuritis in China
- ClinicalTrials.gov ID
- NCT04257734
- Acronym / sponsor ID
- CONSG1
- Conditions
- Optic Neuritis
- Keywords
- optic neuritis, clinical Characteristics, epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Collaborators
- Peking University Health Science Center
- Study start
- 1 May 2020 (actual)
- Primary completion
- 3 Dec 2020 (actual)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 6 Feb 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 will be a hospital-based retrospective multi-center study on epidemiologic and clinical characteristics of optic neuritis among Chinese. The investigation will cover about 29 provinces or municipalities all around China.
Detailed description
This national investigation will be conducted to describe the epidemiology and clinical characteristics of optic neuritis in China. All the patients will be divided into 3 groups according to the serum demyelinating antibodies (Aquaporin-4 antibody seropositive group, Myelin oligodendrocyte glycoprotein antibody seropositive group and double seronegative group). The investigator will analyze the differences among the three groups.
Primary outcomes:
- To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;
- To calculate the annual relapse rate (ARR) differences among the three groups (relapse times in all the follow-up time in each group/ follow-up time (years) in all in each group).
Secondary outcomes:
- Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups;
- Orbital or Brain MRI is required in this study, which could avoid the misdiagnosis. We will collect and analyze these MRI data too (including the optic nerve lesions in T2 weight images and T1 enhanced MRI);
- Results of optical coherence tomography (OCT) (including peripapillary retinal nerve fiber layer, macular thickness ,and ganglion cell and inner plexiform layer complex) at different time point are also needed in this study. However, OCT is not necessarily required;
- Visual fields at different time points are also encouraged to provide if they are available.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| optic neuritis | – | Other: observationAquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Optic neuritis patients with complete medical records in multicenter from China.
Key inclusion criteria (2 listed)
- Clinical diagnosis of optic neuritis
- The patients' medical records were complete
Key exclusion criteria (2 listed)
- Patients with unclear diagnosis of optic neuritis
- Incomplete medical records
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 |
|---|---|---|
| observationdifferent serum antibodies status | Other | optic neuritis |
Primary outcome
Visual Acuity
Time frame: At least 1 year from the attack to the final visit
Last visual acuity records in the hospital
Annual Relapse Rate
Time frame: At least 1 year from the attack to the final visit
Calculated annual relapse rate of different subgroups in the cohort
4 secondary outcomes
Epidemiologic characteristics of optic neuritis
Time frame: At least 1 year from the attack to the final visit
Clinical characteristics of optic neuritis
Time frame: At least 1 year from the attack to the final visit
Optical Coherence Tomography
Time frame: At least 1 year from the attack to the final visit
Orbit or Brain MRI at the attack
Time frame: At least 1 year from the attack to the final visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2021.
- Individual participant dataSharing planned: Undecided. It is a multi center study of optic neuritis, the individual participant data belongs to every single center. Now, we are applying for the approval. However, the details will not be available until all the centers approved.
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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.
Shihui Wei, M.D study chair
Ophthalmology, the Chinese PLA General Hospital
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 Chinese PLA General Hospital 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 2 inclusion and 2 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 20 Jan 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 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 Mo Yang, Ph.D (+86-010-66938375, doctoryangmo@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Acuity (time frame: At least 1 year from the attack to the final visit). 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 20 Jan 2021.