Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2025-12-26 @ 3:11 AM
Study NCT ID:
NCT03894020
Status:
TERMINATED
Last Update Posted:
2024-10-30
First Post:
2019-03-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D057088', 'term': 'Anetoderma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D012868', 'term': 'Skin Abnormalities'}, {'id': 'D012871', 'term': 'Skin Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Saliva Samples, blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated due to the interim analysis demonstrating lack of treatment efficacy.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-28', 'studyFirstSubmitDate': '2019-03-22', 'studyFirstSubmitQcDate': '2019-03-27', 'lastUpdatePostDateStruct': {'date': '2024-10-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Geographic Atrophy (GA)', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in area of Geographic Atrophy, as assessed by Fundus Auto Fluoresence measured in mm2'}, {'measure': 'Colour Fundus (CF)', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in Colour Fundus Photography measured in mm2'}, {'measure': 'Retinal Drusen Volume', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in retinal drusen volume measured in mm3'}, {'measure': 'Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in ETDRS BCVA reading score'}, {'measure': 'Retinal sensitivity', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in retinal sensitivity as assessed by microperimetry'}, {'measure': 'Visual Functioning Questionnaire', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in National Eye Institute Visual Functioning Questionnaire 25-Items Version (NEI VFQ-25) Minimum Score (Best) = 29. Maximum score (Worst) = 149'}, {'measure': 'Medical Events of Interest (MEI)', 'timeFrame': 'Up to 96 weeks', 'description': 'Change from baseline in percentage of Participants with MEI'}, {'measure': 'Monocular and Binocular Reading Performance', 'timeFrame': 'Up to 96 weeks', 'description': 'Change in Monocular and Binocular Reading Performance measured in words/min'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dry Age-related Macular Degeneration', 'Macular Degeneration', 'Retinal Disease', 'Retinal Degeneration', 'Geographic Atrophy', 'Macular Atrophy']}, 'descriptionModule': {'briefSummary': 'An observational study to evaluate the natural progression of dry AMD in genetically defined subjects', 'detailedDescription': 'Prospective, observational study to evaluate the natural progression of anatomical and functional visual parameters in genetically defined subjects with GA due to AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Secondary care.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Adults with unilateral or bilateral Geographic Atrophy (GA) due to Age-related Macular Degeneration (AMD)\n2. BCVA of 40 letters or better using ETDRS charts\n\nExclusion Criteria:\n\n1. Evidence or history of neovascular Age-related Macular Degeneration (AMD) or diabetic retinopathy\n2. Significant ocular or non-ocular disease that would impact the subject's ability to participate in the study\n3. Participation in another research study involving an investigational product within the previous 4 weeks or 5 half-lives whichever is longer from the screening/baseline OR received a gene/cell therapy at any time previously"}, 'identificationModule': {'nctId': 'NCT03894020', 'briefTitle': 'GTSCOPE - To Evaluate the Natural Progression of Dry Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gyroscope Therapeutics Limited'}, 'officialTitle': 'A Study of Disease Progression in Genetically Defined Subjects With Geographic Atrophy (GA) Secondary to Age-related Macular Degeneration (AMD)', 'orgStudyIdInfo': {'id': 'GTSCOPE'}, 'secondaryIdInfos': [{'id': 'CPPY988A12001', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute (retina consultants of AZ)', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Centers PC', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94303', 'city': 'Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'Byers Eye Institute at Stanford', 'geoPoint': {'lat': 37.44188, 'lon': -122.14302}}, {'zip': '33907', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Health Center', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '30060', 'city': 'Marietta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Georgia Retina PC', 'geoPoint': {'lat': 33.9526, 'lon': -84.54993}}, {'zip': '60452', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina Macula Associates PC', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '46290', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute Northside', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '50266', 'city': 'West Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Wolfe Eye Clinic', 'geoPoint': {'lat': 41.57721, 'lon': -93.71133}}, {'zip': '21209', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'The Retina Care Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Medicine', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalamic Consultants of Boston (OCB)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pepose Vision Institute', 'geoPoint': {'lat': 38.66311, 'lon': -90.57707}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra Eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '07088', 'city': 'Vauxhall', 'state': 'New Jersey', 'country': 'United States', 'facility': 'New Jersey Retina Research Foundation', 'geoPoint': {'lat': 40.718, 'lon': -74.284}}, {'zip': '11021', 'city': 'Great Neck', 'state': 'New York', 'country': 'United States', 'facility': 'Long Island Vitreoretinal Consultants', 'geoPoint': {'lat': 40.80066, 'lon': -73.72846}}, {'zip': '10032', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Columbia University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Retina Association of Western New York', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wake Forest Baptist Medical Center - 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