Ignite Creation Date:
2025-12-26 @ 12:16 PM
Ignite Modification Date:
2026-03-03 @ 6:29 AM
Study NCT ID:
NCT06346600
Status:
RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-03-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 83}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-03', 'studyFirstSubmitDate': '2024-03-27', 'studyFirstSubmitQcDate': '2024-04-03', 'lastUpdatePostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Type, severity, and incidence of ocular and systemic adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs)', 'timeFrame': '5 years post study drug injection'}], 'secondaryOutcomes': [{'measure': 'Mean change in best corrected visual acuity (BCVA) at each visit from baseline', 'timeFrame': '5 years post study drug injection', 'description': 'BCVA of the study eye is examined by the Early Treatment of Diabetic Retinopathy Study (ETDRS) testing at each visit.'}, {'measure': 'Mean change in macular central subfield thickness (CST) at each visit from baseline', 'timeFrame': '5 years post study drug injection', 'description': 'Spectral domain optical coherence tomography (SD-OCT) will be performed to measure CST at each visit.'}, {'measure': 'Mean change in patient-reported outcome (VFQ-25) scale scores at each visit from baseline', 'timeFrame': '5 years post study drug injection', 'description': 'Both the total scale and subscale scores of the VFQ-25 is ranging from 0 to 100, and higher scores mean a better outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nAMD', 'wAMD'], 'conditions': ['Neovascular (Wet) Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This is a Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients with Neovascular (Wet) Age-related Macular Degeneration (nAMD). All subject who completed the parent clinical study (NCT06213038 and NCT05986864) will undergo safety and efficacy assessments up to 5 years post study drug injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'It is expected that a total of 83 study subjects from parent study will be enrolled. Subjects who meet all the inclusion criteria and for whom none of the exclusion criteria apply will be eligible for enrollment.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nSubjects who only meet all of the following criteria are eligible for this study:\n\n* nAMD subjects who have been enrolled in the SKG0106-related study and received SKG0106 injection;\n* Subjects who voluntarily sign an informed consent form (ICF) and comply with the protocol to complete the study\n\nExclusion Criteria:\n\n* Subjects who are judged by the investigator unsuitable for this study'}, 'identificationModule': {'nctId': 'NCT06346600', 'briefTitle': 'A Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With nAMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Skyline Therapeutics'}, 'officialTitle': 'A Prospective, Non-interventional, Multicenter, Long-term Follow-up Study to Evaluate SKG0106 in the Treatment of Patients With Neovascular (Wet) Age-related Macular Degeneration (nAMD)', 'orgStudyIdInfo': {'id': 'SKG0106-LF'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1', 'description': 'No investigational product will be administered in this study.', 'interventionNames': ['Genetic: SKG0106']}, {'label': 'Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2', 'description': 'No investigational product will be administered in this study.', 'interventionNames': ['Genetic: SKG0106']}, {'label': 'Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3', 'description': 'No investigational product will be administered in this study.', 'interventionNames': ['Genetic: SKG0106']}], 'interventions': [{'name': 'SKG0106', 'type': 'GENETIC', 'description': 'Non-interventional (observational) study, long-term follow-up safety and efficacy assessments up to 5 years post SKG0106 injection.', 'armGroupLabels': ['Long-term Follow-Up of Participants exposed to SKG0106 Dose level 1', 'Long-term Follow-Up of Participants exposed to SKG0106 Dose level 2', 'Long-term Follow-Up of Participants exposed to SKG0106 Dose level 3']}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '23502', 'city': 'Norfolk', 'state': 'Virginia', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Wagner Macula & Retina Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'city': 'Hefei', 'state': 'Anhui', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'The Second Hospital Of Anhui Medical University', 'geoPoint': {'lat': 31.86389, 'lon': 117.28083}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': "Zhejiang Provincial People's Hospital", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Wenzhou', 'state': 'Zhejiang', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Eye Hospital, WMU (Zhejiang Eye Hospital)', 'geoPoint': {'lat': 27.99942, 'lon': 120.66682}}, {'city': 'Beijing', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'facility': 'EYE & ENT Hospital of Fudan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'facility': 'Xinhua Hospital Affiliated To Shanghai Jiao Tong University School Of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Yongqin Wang', 'role': 'CONTACT', 'email': 'yongqin.wang@skytx.com', 'phone': '+86 18616737445'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Skyline Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}