Ignite Creation Date:
2025-12-24 @ 7:13 PM
Ignite Modification Date:
2025-12-30 @ 3:59 AM
Study NCT ID:
NCT05210803
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-06-18
First Post:
2022-01-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 115}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-12-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-16', 'studyFirstSubmitDate': '2022-01-14', 'studyFirstSubmitQcDate': '2022-01-14', 'lastUpdatePostDateStruct': {'date': '2025-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the long-term safety of RGX-314', 'timeFrame': '5 years inclusive of parent study', 'description': 'Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest'}], 'secondaryOutcomes': [{'measure': '• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)', 'timeFrame': '5 years inclusive of parent study', 'description': '• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA'}, {'measure': '• To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)', 'timeFrame': '5 years inclusive of parent study', 'description': '• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT'}, {'measure': '• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy', 'timeFrame': '5 years inclusive of parent study', 'description': '• Mean number of supplemental anti-VEGF injections based on chart review'}, {'measure': '• To assess the need of clinic visits for management of nAMD', 'timeFrame': '5 years inclusive of parent study', 'description': '• Mean number of retina specialist visits attended for nAMD based on chart review'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-Related Macular Degeneration (nAMD)', 'Gene Therapy', 'AMD', 'Wet AMD', 'wAMD', 'nAMD']}, 'descriptionModule': {'briefSummary': 'This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The sample sizes were determined by the parent studies and all participants who received an SCS administration of RGX-314 will be invited to participate in the long-term follow-up study. All Enrolled Population: Includes all participants who are enrolled in the long-term follow-up study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Must provide written, signed informed consent for this study.\n2. Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.\n3. Must be willing and able to comply with all study procedures.\n\nExclusion Criteria:\n\n1\\. None'}, 'identificationModule': {'nctId': 'NCT05210803', 'briefTitle': 'Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'RGX-314-5102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Roll over', 'description': 'No intervention All subjects that previously received RGX-314 in a parent study', 'interventionNames': ['Other: No intervention.']}], 'interventions': [{'name': 'No intervention.', 'type': 'OTHER', 'description': 'All subjects that previously received RGX-314 in a parent study', 'armGroupLabels': ['Roll over']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85014', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retinal Research Institute, LLC', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '94040', 'city': 'Mountain View', 'state': 'California', 'country': 'United States', 'facility': 'Northern California Retina Vitreous Associates Medical Group Inc', 'geoPoint': {'lat': 37.38605, 'lon': -122.08385}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '93103', 'city': 'Santa Barbara', 'state': 'California', 'country': 'United States', 'facility': 'California Retina Consultants', 'geoPoint': {'lat': 34.42083, 'lon': -119.69819}}, {'zip': '30909', 'city': 'Augusta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Southeast Retina Center PC', 'geoPoint': {'lat': 33.47097, 'lon': -81.97484}}, {'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Vitreoretinal Surgery PLLC', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Sierra eye Associates', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '87109', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'Vision Research Center Eye Associates of New Mexico', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Retinovitreous Associates, LTD', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institute, P.C', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Tennessee Retina, PC', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}