Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-02-27 @ 4:07 PM
Study NCT ID:
NCT03281005
Status:
COMPLETED
Last Update Posted:
2024-10-21
First Post:
2017-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Visual Function Evaluation Method
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012174', 'term': 'Retinitis Pigmentosa'}], 'ancestors': [{'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D058499', 'term': 'Retinal Dystrophies'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-03', 'completionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-18', 'studyFirstSubmitDate': '2017-09-11', 'studyFirstSubmitQcDate': '2017-09-11', 'lastUpdatePostDateStruct': {'date': '2024-10-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-21', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Slit-lamp microscopy in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Slit-lamp microscopy in Part 1B and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Optical Coherence Tomography (OCT) test in Part 1A and 2', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Visual acuity test with Early Treatment Diabetic Retinopathy Study (ETDRS) in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Visual acuity test with ETDRS in Part 1B', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'The 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function and the quality of life (QOL)'}, {'measure': 'The 11-item National Eye Institute Visual Function Questionnaire (NEI VFQ-11) in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function and QOL'}, {'measure': 'Nottingham Adjustment Scale Japanese Version (NAS-J) in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the psychological adjustment'}, {'measure': 'Daily living task dependent on vision (DLTV) in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess QOL'}, {'measure': 'Table test in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Metropsis test in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Low vision evaluator (LoVE) in Part 1A', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'White flash visual evoked potential (VEP) test in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'White flash VEP test in Part 1B and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Color flash VEP test in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Color flash VEP test in Part 1B and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Electrically evoked response (EER) test in Part 1A and 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'EER test in Part 1B and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'White flash electroretinography test in Part 1A, 1B, 2 and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Pupillary function test in Part 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'Pupillary function test in Part 1B and 3', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}, {'measure': 'Full field stimulus threshold testing (FST) in Part 2', 'timeFrame': 'Up to week 8', 'description': 'To assess the visual function'}, {'measure': 'FST in Part 1B', 'timeFrame': 'Day 1', 'description': 'To assess the visual function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Retinitis pigmentosa', 'Visual function evaluation'], 'conditions': ['Retinitis Pigmentosa']}, 'referencesModule': {'references': [{'pmid': '37895218', 'type': 'DERIVED', 'citation': 'Fujinami-Yokokawa Y, Yang L, Joo K, Tsunoda K, Liu X, Kondo M, Ahn SJ, Li H, Park KH, Tachimori H, Miyata H, Woo SJ, Sui R, Fujinami K. Occult Macular Dysfunction Syndrome: Identification of Multiple Pathologies in a Clinical Spectrum of Macular Dysfunction with Normal Fundus in East Asian Patients: EAOMD Report No. 5. Genes (Basel). 2023 Sep 26;14(10):1869. doi: 10.3390/genes14101869.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to develop the comprehensive visual function evaluation method in severe visually impaired patient', 'detailedDescription': 'This study is a prospective observational study which consists of 4 Parts; Part 1A, 1B, 2 and 3. Part 1A has been conducted on 6 subjects diagnosed with retinitis pigmentosa. Additional examination will be performed using alternative devices imported outside Japan on subjects who completed Part 1A and re-consented (Part 1B). Based on the interim result of Part 1A, Part 2 will be conducted on another 6 subjects with retinitis pigmentosa with improved methodology and the devices used in Part 1B. Part 3 will be conducted in 6 healthy volunteers to obtain comparative data using devices used in Part 1B.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Retinitis pigmentosa, healthy volunteers', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria for patients with retinitis pigmentosa:\n\n* Age: ≥ 20 years\n* Subjects with severe visual disturbance (count-fingers or worse vision for severe eyes) at the time of obtaining the consent\n\nInclusion Criteria for healthy Volunteers:\n\n* Age: ≥ 35 and ≤ 75 years\n* Subjects with corrected visual acuity ≥ 1.0 with both eyes and without severe refractive error nor abnormal findings in slit-lamp microscopy, OCT, fundoscopy and pupillary function test at screening\n\nExclusion Criteria:\n\n* Subjects who have participated in any other clinical trial or clinical study involving visual function evaluation within 6 months\n* Subjects who have history of surgery, past history, and complications (cardiac/ hepatic/ renal/ respiratory/ hematological diseases, optic nerve diseases causing marked loss of visual field, and uveitis etc.) that potentially affect evaluation and safety of the study\n* Pregnant women\n* Subjects who are judged that continuation of the study is difficult during the study period\n* Subjects who are employed by the company sponsoring this study, an organization or institution related to this study'}, 'identificationModule': {'nctId': 'NCT03281005', 'briefTitle': 'Development of Visual Function Evaluation Method', 'organization': {'class': 'INDUSTRY', 'fullName': 'Astellas Pharma Inc'}, 'officialTitle': 'Calibration of Visual Function Evaluation Tests in Patients With Severe Vision Loss', 'orgStudyIdInfo': {'id': 'CRE170041'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Retinitis pigmentosa in Part 1A', 'description': 'Retinitis pigmentosa patients with severe visual impairment'}, {'label': 'Retinitis pigmentosa in Part 1B', 'description': 'Retinitis pigmentosa patients with severe visual impairment'}, {'label': 'Retinitis pigmentosa in Part 2', 'description': 'Retinitis pigmentosa patients with severe visual impairment'}, {'label': 'Healthy volunteers in Part 3', 'description': 'Healthy volunteers'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Meguro-ku', 'state': 'Tokyo', 'country': 'Japan', 'facility': 'Site JP00001'}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Astellas Pharma Inc'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': "Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/."}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Astellas Pharma Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}