Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-28 @ 12:12 AM
Study NCT ID:
NCT04257734
Status:
UNKNOWN
Last Update Posted:
2021-01-20
First Post:
2020-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Epidemiologic and Clinical Characteristics of Optic Neuritis in China
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009902', 'term': 'Optic Neuritis'}], 'ancestors': [{'id': 'D009901', 'term': 'Optic Nerve Diseases'}, {'id': 'D003389', 'term': 'Cranial Nerve Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2021-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-01-17', 'studyFirstSubmitDate': '2020-02-04', 'studyFirstSubmitQcDate': '2020-02-04', 'lastUpdatePostDateStruct': {'date': '2021-01-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'Last visual acuity records in the hospital'}, {'measure': 'Annual Relapse Rate', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'Calculated annual relapse rate of different subgroups in the cohort'}], 'secondaryOutcomes': [{'measure': 'Epidemiologic characteristics of optic neuritis', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'Gender, age of first attack, location'}, {'measure': 'Clinical characteristics of optic neuritis', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'Visual acuity at nadir, pain, optic disc edema'}, {'measure': 'Optical Coherence Tomography', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'RNFL, macular thickness and GCIPL at different time points'}, {'measure': 'Orbit or Brain MRI at the attack', 'timeFrame': 'At least 1 year from the attack to the final visit', 'description': 'Lesions of the optic nerve'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['optic neuritis', 'clinical Characteristics', 'epidemiology'], 'conditions': ['Optic Neuritis']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nPrimary outcomes:\n\n* To dig out the different visual acuity (VA, LogMAR) prognosis among the three groups;\n\n * 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).\n\nSecondary outcomes:\n\n* Other epidemiological and clinical characteristics of optic neuritis patients will be analyzed among the three groups;\n\n * 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);\n\n * 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;\n\n * Visual fields at different time points are also encouraged to provide if they are available.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Optic neuritis patients with complete medical records in multicenter from China.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Clinical diagnosis of optic neuritis\n2. The patients' medical records were complete\n\nExclusion Criteria:\n\n1. Patients with unclear diagnosis of optic neuritis\n2. Incomplete medical records"}, 'identificationModule': {'nctId': 'NCT04257734', 'briefTitle': 'Epidemiologic and Clinical Characteristics of Optic Neuritis in China', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Epidemiologic and Clinical Characteristics of Optic Neuritis in China', 'orgStudyIdInfo': {'id': 'CONSG1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'optic neuritis', 'description': 'Aquaporin 4 antibody seropositive optic neuritis patients, Myelin oligodendrocyte glycoprotein antibody seropositive optic neuritis patients, and double antibodies seronegative optic neuritis patients', 'interventionNames': ['Other: observation']}], 'interventions': [{'name': 'observation', 'type': 'OTHER', 'description': 'different serum antibodies status', 'armGroupLabels': ['optic neuritis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100835', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Mo Yang, PhD', 'role': 'CONTACT', 'email': 'doctoryangmo@icloud.com', 'phone': '+86-183-1009-8349'}], 'facility': 'Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Mo Yang, Ph.D', 'role': 'CONTACT', 'email': 'doctoryangmo@icloud.com', 'phone': '+86-010-66938375'}, {'name': 'Mengying Lai, M.D', 'role': 'CONTACT', 'email': '78313749@qq.com', 'phone': '+86-010-66938175'}], 'overallOfficials': [{'name': 'Shihui Wei, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Ophthalmology, the Chinese PLA General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University Health Science Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Wei Shihui', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}