Ignite Creation Date:
2025-12-25 @ 5:08 AM
Ignite Modification Date:
2025-12-26 @ 4:12 AM
Study NCT ID:
NCT05481827
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-03-22
First Post:
2022-07-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057092', 'term': 'Geographic Atrophy'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 225}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-07-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2028-06-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-21', 'studyFirstSubmitDate': '2022-07-28', 'studyFirstSubmitQcDate': '2022-07-29', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-06-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence and severity of ocular and systemic adverse events (AEs)', 'timeFrame': 'up to Week 260', 'description': 'An AE is the development of an undesirable medical condition or the deterioration of a preexisting medical condition following or during exposure to a pharmaceutical product, whether or not considered causally related to the IMP.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Geographic Atrophy', 'Retinal disease', 'Retinal degeneration', 'Macular atrophy', 'Dry age-related macular degeneration', 'Macular degeneration', 'age-related macular degeneration (ARMD)', 'retina damage', 'dry macular degeneration', 'AMD'], 'conditions': ['Age Related Macular Degeneration (AMD)']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the long-term safety of GT005 in participants with Geographic Atrophy (GA) secondary to AMD who have been treated in an antecedent study.', 'detailedDescription': 'This is a prospective, multi-centre, long-term, follow-up study for participants who have previously received GT005 in one of the antecedent clinical studies which were prematurely terminated GT005-01 (FOCUS), GT005-02 (EXPLORE) or GT005-03 (HORIZON). Participants from GT005-01 (FOCUS) study with only 1 last study visit to be conducted (Week 240) will remain in the study to complete their last visit. No investigational product will be administered within this study, and participants will be invited to enter ORACLE upon their completion or termination of the antecedent interventional study (whichever is soonest). This study will consist of up to three study visits prior to Week 96, and up to five study visits thereafter, for an overall period of 5-years post-GT005 administration.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Able and willing to give written informed consent\n2. Received GT005 in an antecedent study, GT005-01 (FOCUS, NCT03846193), GT005-02 (EXPLORE, NCT04437368) and GT005-03 (HORIZON, NCT04566445)\n3. Willing to attend study visits and complete the study procedures.'}, 'identificationModule': {'nctId': 'NCT05481827', 'acronym': 'ORACLE', 'briefTitle': 'ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study', 'organization': {'class': 'INDUSTRY', 'fullName': 'Gyroscope Therapeutics Limited'}, 'officialTitle': 'ORACLE: A Long-term Follow-up Study to Evaluate the Safety of GT005 in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration Treated in a Gyroscope-sponsored Antecedent Study', 'orgStudyIdInfo': {'id': 'GT-ORACLE'}, 'secondaryIdInfos': [{'id': '2020-003987-22', 'type': 'EUDRACT_NUMBER'}, {'id': 'CPPY988A12203B', 'type': 'OTHER', 'domain': 'Novartis'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GT005', 'description': 'GT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study', 'interventionNames': ['Genetic: GT005']}], 'interventions': [{'name': 'GT005', 'type': 'GENETIC', 'description': 'GT005 is a gene therapy for GA and is a recombinant adeno-associated viral serotype 2 (AAV2) vector encoding for human complement factor I. GT005 was administered to all participants in an antecedent study prior to enrollment in ORACLE and GT005 is not administered in the ORACLE study.', 'armGroupLabels': ['GT005']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants San Diego - Poway', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '81303', 'city': 'Durango', 'state': 'Colorado', 'country': 'United States', 'facility': 'Southwest Retina Research Center', 'geoPoint': {'lat': 37.27528, 'lon': -107.88007}}, {'zip': '32607-2557', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'Vitreo Retinal Associates Pa - the Millennium Center Location', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}, {'zip': '33064', 'city': 'Pompano Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Rand Eye Institute, Inc. (Rei)', 'geoPoint': {'lat': 26.23786, 'lon': -80.12477}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '60439-7421', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina and Macula Associates, P.C. - Lemont Office', '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, Llc - Baltimore Location', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston (OCB)', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '63017', 'city': 'Chesterfield', 'state': 'Missouri', 'country': 'United States', 'facility': 'Pepose Vision Institute, P.C - Midwest Vision Research Foundation', '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': '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 Associates of Western New York', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cincinnati Eye Institute', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97401-2127', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Sterling Vision - Oregon Retina, Llp', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Mid Atlantic Retina - Wills Eye Hospital', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '75231', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates (Tra) - Dallas Main', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030-2727', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas (Retina Consultants of Houston) - Texas Medical Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Retinal Consultants of San Antonio (Rcsa) - Medical Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '3002', 'city': 'Melbourne E.', 'state': 'Victoria', 'country': 'Australia', 'facility': 'The University of Melbourne - The Centre for Eye Research Australia (CERA)'}, {'zip': '21000', 'city': 'Dijon', 'country': 'France', 'facility': 'CHU Dijon - Hopital Mitterrand', 'geoPoint': {'lat': 47.31344, 'lon': 5.01391}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'CHU de Nantes - Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '23538', 'city': 'Lübeck', 'country': 'Germany', 'facility': 'Universitaetsklinikum Schleswig-Holstein', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'Universitaetsklinikum Tuebingen', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}, {'zip': '08035', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Instituto de microcirugía ocular', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'zip': '28046', 'city': 'Madrid', 'country': 'Spain', 'facility': 'Clinica Baviera', 'geoPoint': {'lat': 40.4165, 'lon': -3.70256}}, {'zip': '31008', 'city': 'Pamplona', 'country': 'Spain', 'facility': 'Clinica Universidad de Navarra - Pamplona', 'geoPoint': {'lat': 42.81687, 'lon': -1.64323}}, {'zip': 'W1G 7LB', 'city': 'London', 'country': 'United Kingdom', 'facility': 'The Retina Clinic London', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'SR2 9HP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'South Tyneside and Sunderland Nhs Foundation Trust - Sunderland Eye Infirmary', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gyroscope Therapeutics Limited', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}