Ignite Creation Date:
2025-12-24 @ 5:40 PM
Ignite Modification Date:
2026-01-06 @ 6:16 AM
Study NCT ID:
NCT03691168
Status:
UNKNOWN
Last Update Posted:
2018-10-01
First Post:
2018-09-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2023-05-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-09-28', 'studyFirstSubmitDate': '2018-09-28', 'studyFirstSubmitQcDate': '2018-09-28', 'lastUpdatePostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '60 months', 'description': 'A typical Snellen chart that if frequently used for visual acuity testing'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inherited retinal dystrophies, Gene screen'], 'conditions': ['Inherited Retinal Dystrophies']}, 'descriptionModule': {'briefSummary': 'Based on a clinical multi-center study of the natural course of inherited retinal dystrophies in Chinese population, screening fundus imaging indicators for patients with Chinese inherited retinal dystrophies, describing the clinical features of Chinese patients with inherited retinal dystrophies, and establishing a diagnosis of hereditary retinal diseases - Follow-up norms; establish a network-based multi-center diagnosis and follow-up platform; obtain a biological sample library of hereditary retinal diseases mainly in China. The research will further improve and enrich the genotype, phenotypic characteristics and natural course of Chinese inherited retinal dystrophies, in order to promote the clinical evaluation of clinical inherited retinal dystrophies and the standardization of genetic diagnosis. It is also the evidence for the best timing for future gene therapy, to obtain the best therapeutic effect, and to provide a theoretical basis for achieving precise treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '4 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with inherited retinal dystrophies', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients with IRDs whose mutations have been identified\n2. 4\\~70 years old\n3. Complete 4 basic examinations of the eye: Corrective vision; fundus photography; OCT; ERG\n\nExclusion Criteria:\n\n1. Has participated in other interventional treatment studies;\n2. Patients with severe systemic diseases, mental dysplasia, mental illness;\n3. Unable to accept eye examination patients;\n4. Traumatic retinopathy, retinal inflammatory disease, paraneoplastic retinopathy, drug toxicity, and rare diseases such as diffuse unilateral subacute optic retinitis\n5. At the initial visit, the patient's binocular vision is displayed as no light.\n6. Both eyes have a history of internal eye surgery"}, 'identificationModule': {'nctId': 'NCT03691168', 'acronym': 'RID', 'briefTitle': 'Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'Multi-center Observation of the Natural Course of Inherited Retinal Dystrophies', 'orgStudyIdInfo': {'id': 'Shanghai1stSXD'}}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'huixun Jia, Master', 'role': 'CONTACT', 'email': 'jiahuixun@163.com', 'phone': '+86 18017317575'}, {'name': 'Wenqiu Wang, PHD', 'role': 'CONTACT', 'email': 'wangwenqiu@126.com', 'phone': '+86 13817062881'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'huixun Jia, Master', 'role': 'CONTACT', 'email': 'jiahuixun@163.com', 'phone': '+86 18017317575'}, {'name': 'Wenqiu Wang, PHD', 'role': 'CONTACT', 'email': 'wangwenqiu@126.com', 'phone': '+86 13817062881'}], 'overallOfficials': [{'name': 'XiaoDong Sun, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiaodong Sun', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}