Ignite Creation Date:
2025-12-26 @ 11:07 AM
Ignite Modification Date:
2025-12-29 @ 4:26 AM
Study NCT ID:
NCT04645212
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-07
First Post:
2020-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D001766', 'term': 'Blindness'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-06', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-11-20', 'lastUpdatePostDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-11-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, severity and incidence of ocular and systemic adverse events (AEs).', 'timeFrame': '156 weeks', 'description': 'Type, severity and incidence of ocular and systemic adverse events'}], 'secondaryOutcomes': [{'measure': 'Change in best corrected visual acuity (BCVA) from baseline, over time', 'timeFrame': '156 weeks', 'description': 'Change in best corrected visual acuity (BCVA) from baseline, over time'}, {'measure': 'Mean change in central subfield thickness (CST) and macular volume from baseline, over time', 'timeFrame': '156 weeks', 'description': 'Mean change in central subfield thickness (CST) and macular volume from baseline, over time'}, {'measure': 'Percentage of subjects requiring supplemental aflibercept over time', 'timeFrame': '156 weeks', 'description': 'Percentage of subjects requiring supplemental aflibercept over time'}, {'measure': 'Mean number of supplemental aflibercept injections over time', 'timeFrame': '156 weeks', 'description': 'Mean number of supplemental aflibercept injections over time'}, {'measure': 'Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time', 'timeFrame': '156 weeks', 'description': 'Percentage of subjects without intraretinal fluid (IRF) by spectral domain optical coherence tomography (SD-OCT), over time'}, {'measure': 'Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time', 'timeFrame': '156 weeks', 'description': 'Percentage of subjects without subretinal fluid (SRF) by SD-OCT over time'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Choroidal Neovascularization', 'ADVM-022', 'OPTIC Study', 'CNV', 'ADVM-022-01', 'ADVM-022-07', 'AAV.7m8', 'Anti-VEGF therapy', 'Blindness', 'Gene therapy', 'Aflibercept (Eylea)', 'Age-Related Macular Degeneration', 'Wet Macular Degeneration', 'Retinal Degeneration', 'Retinal Diseases', 'Eye Diseases', 'AAV Vector', 'Adverum', 'wAMD', 'AMD', 'wet AMD', 'nAMD', 'OPTIC Extension', 'OPTIC-EXT', 'Long-term Follow Up', 'Long-term Extension'], 'conditions': ['Wet Age-related Macular Degeneration', 'Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'ADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).', 'detailedDescription': 'ADVM-022 (AAV.7m8-aflibercept) is a gene therapy product developed for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is a serious condition and the leading cause of blindness in the elderly. The available therapies for treating wet AMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. A one-time IVT administration of ADVM-022 has the potential to treat wet AMD by providing durable expression of therapeutic levels of intraocular anti-VEGF protein (aflibercept) and maintaining the vision of patients. ADVM-022 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with wet AMD receiving anti-VEGF therapy in clinical practice.\n\nADVM-022-07 is an observational long-term extension (OPTIC-EXT) study assessing safety and efficacy of ADVM-022 gene therapy product, in subjects with neovascular, or exudative (wet), age-related macular degeneration (nAMD).\n\nTo evaluate potential long-term outcomes of ADVM-022, the OPTIC-EXT will follow subjects previously treated in the OPTIC parent study (Clinical Protocol No. ADVM-022-01 \\[OPTIC\\] (NCT03748784)). Subjects will roll over from the OPTIC parent study and will be followed for 3 additional years, following completion of the preceding 2-year assessment period in the OPTIC parent study. There is no investigational treatment administered in this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '* Subjects who received ADVM-022 at any dose in the OPTIC study\n* Up to 30 subjects from all cohorts of OPTIC', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects who received a single dose of ADVM-022 at any dose in the OPTIC study\n* Willing and able to provide informed consent\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04645212', 'briefTitle': 'Long-term Study of ADVM-022 in Neovascular (Wet) AMD [OPTIC-EXT]', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adverum Biotechnologies, Inc.'}, 'officialTitle': 'A Long-term Study of ADVM-022 in Neovascular (Wet) AMD - OPTIC Extension', 'orgStudyIdInfo': {'id': 'ADVM-022-07'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Subjects with wet AMD who received any dose of ADVM-022 in a prior clinical study.', 'interventionNames': ['Biological: ADVM-022']}], 'interventions': [{'name': 'ADVM-022', 'type': 'BIOLOGICAL', 'otherNames': ['AAV.7m8-aflibercept'], 'description': 'Long term follow-up of subjects that received ADVM-022', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '80228', 'city': 'Lakewood', 'state': 'Colorado', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 39.70471, 'lon': -105.08137}}, {'zip': '33064', 'city': 'Deerfield Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 26.31841, 'lon': -80.09977}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'Adverum Clinical Site', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'overallOfficials': [{'name': 'OPTIC Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Adverum Biotechnologies, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adverum Biotechnologies, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}