Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-30 @ 9:49 PM
Study NCT ID:
NCT06458595
Status:
RECRUITING
Last Update Posted:
2024-11-29
First Post:
2024-06-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (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': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-12-28', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-26', 'studyFirstSubmitDate': '2024-06-09', 'studyFirstSubmitQcDate': '2024-06-09', 'lastUpdatePostDateStruct': {'date': '2024-11-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Tolerability and safety of KH658 in different dose levels', 'timeFrame': 'Week 4， Week 26'}, {'measure': 'Change in BCVA letter', 'timeFrame': 'Week 26'}], 'secondaryOutcomes': [{'measure': 'Incidence of adverse events and adverse reactions', 'timeFrame': 'Week 4， 26， 38， 54'}, {'measure': 'Efficacy (BCVA, CRT)', 'timeFrame': 'Week 38， 54'}, {'measure': 'Number of supplemental injections', 'timeFrame': 'Week 54'}, {'measure': 'Annualized rate of supplemental injections', 'timeFrame': 'Week 54'}, {'measure': 'Percentage of subjects free of rescue IVT therapy', 'timeFrame': 'Week 54'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'KH658 is a adeno-associated virus (AAV) vector-based gene therapy for suprachoroidal space injection. The long-term, stable therapeutic protein after one time injection for nAMD could potentially reduce the treatment burden and maintain vision.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Are willing and able to sign the informed consent form (ICF);\n2. Female and male aged 50 to 85 years (inclusive) with nAMD;\n3. Have previously received anti-VEGF treatment for nAMD, with documented response to anti-VEGF therapy and a minimum of 2 anti-VEGF IVT injections in the study eye in the 6 months prior to screening;\n4. Have a ETDRS BCVA letter score of 83 to 19 (approximately 20/25 to 20/400 Snellen equivalent) in the study eye at Screening;\n5. Have a ETDRS BCVA letter score of ≥19 in the fellow eye at Screening;\n6. Females must be at least 1 year postmenopausal.\n\nExclusion Criteria:\n\n1. Have any other cause of CNV (such as pathological myopia, etc.) in the study eye; or non-nAMD disease in the study eye judged by the investigator that could impact macular examination or affect central vision (such as diabetic retinopathy, central retinal vein occlusion, etc.);\n2. Any condition preventing visual acuity improvement in the study eye, e.g. fovea scar, fibrosis or atrophy;\n3. Have a subretinal hemorrhage that is either 50% or more of the total lesion area, or blood is greater than 1.0 mm2 under the fovea in the study eye at screening;\n4. Have any vitreous hemorrhage or history of vitreous hemorrhage in the study eye;\n5. Presence of an implant (excluding intraocular lens), opacification of the refractive medium or miosis that affects fundus examination;\n6. Have a history of or presence of retinal detachment or choroidal detachment in the study eye.'}, 'identificationModule': {'nctId': 'NCT06458595', 'briefTitle': 'Safety and Tolerability of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Chengdu Kanghong Pharmaceutical Group Co., Ltd.'}, 'officialTitle': 'A Phase I/II Study to Evaluate the Tolerability, Safety and Efficacy of KH658 Gene Therapy in Subjects With Neovascular Age-related Macular Degeneration (nAMD).', 'orgStudyIdInfo': {'id': 'KH658-40101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KH658', 'interventionNames': ['Drug: KH658']}], 'interventions': [{'name': 'KH658', 'type': 'DRUG', 'description': 'KH658 Ophthalmic Injection', 'armGroupLabels': ['KH658']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tianjin', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hua Yan, M.D.', 'role': 'CONTACT'}], 'facility': 'Tianjin Medical University General Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'centralContacts': [{'name': 'Jiarong Du', 'role': 'CONTACT', 'email': '026117@cnkh.com', 'phone': '+86176 0288 9310'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chengdu Origen Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}