Ignite Creation Date:
2025-12-24 @ 3:43 PM
Ignite Modification Date:
2025-12-30 @ 3:20 AM
Study NCT ID:
NCT06888492
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-21
First Post:
2025-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Dose escalation'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 8}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-03-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-14', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-25', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability after EXG202 injection', 'timeFrame': 'up to 52 weeks after treatment', 'description': 'Frequency, type, and intensity of ocular and non-ocular Adverse Events (AEs) and serious adverse events (SAE) at Week 52, to explore the maximum tolerated dose (MTD)'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy after EXG202 injection', 'timeFrame': 'up to 52 weeks after treatment', 'description': 'the Best Corrected Visual Acuity (BCVA) change from baseline'}, {'measure': 'To evaluate the efficacy after EXG202 injection', 'timeFrame': '52 weeks following EXG202 treatment.', 'description': 'The optical coherence tomography (OCT ).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['wAMD', 'AAV'], 'conditions': ['Wet Age-related Macular Degeneration (wAMD)', 'Wet Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of intravitreal injection of EXG202 in subjects with neovascular age-related Macular Degeneration (nAMD).', 'detailedDescription': 'EXG 202 is a gene therapy product developed for the treatment of neovascular age-related macular degeneration (nAMD). Neovascular AMD is the main cause of blindness among elderly individuals. The available therapies for treating nAMD require life-long intravitreal (IVT) injections every 4-12 weeks to maintain efficacy. Administration of EXG202 has the potential to treat nAMD by providing durable expression of therapeutic levels of intraocular protein and maintaining the vision of patients. EXG 202 is designed to reduce the current treatment burden which often results in undertreatment and vision loss in patients with nAMD receiving anti-VEGF therapy in clinical practice.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, aged ≥50 years old;\n2. The study eye must meet the following criteria:\n\n A. Diagnosed of wAMD and current active lesions; active, defined as the presence of any of the following lesions in the macular area upon OCT examination: a) intraretinal hemorrhage or fluid; b) subretinal fluid; c) subretinal hemorrhage; B. The BCVA score tested during screening using the ETDRS eye chart (see Appendix 3 for details) must be between 73-19 letters (including boundary values), (equivalent to Snellen visual acuity of 20/40 to 20/400);\n3. Clinically meaningful response to standard anti-VEGF therapy within 6 months before screening or during the lead-in period of screening.\n4. The subject has clear refractive media and sufficient pupil dilation at the time of screening to obtain high-quality retinal images for confirmation of diagnosis;\n5. Subjects (including male subjects) have no pregnancy plans during the screening period and the entire trial period and voluntarily take effective contraceptive measures and have no sperm or egg donation plans;\n6. Voluntarily participate in this clinical trial, understand the research procedures and sign the informed consent form before screening; have good compliance and are willing to abide by the research procedures.\n\nExclusion Criteria:\n\n1. The study eye has any eye disease other than wAMD that may affect central vision and/or macular detection (such as macular hole, macular epiretinal membrane, etc.);\n2. The study eye has a history of retinal detachment or retinal detachment during the screening period (such as rhegmatogenous retinal detachment, tractional retinal detachment, etc.);\n3. The study eye has MNV caused by reasons other than wAMD (such as diabetic retinopathy, pathological myopia, retinal vein occlusion, angioid streak disease, ocular histoplasmosis, trauma, etc.), and a history of macular pathology unrelated to wAMD;\n4. The study eye plans to undergo any intraocular surgery during the study period;'}, 'identificationModule': {'nctId': 'NCT06888492', 'briefTitle': 'To Evaluate the Safety and Preliminary Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Hangzhou Jiayin Biotech Ltd'}, 'officialTitle': 'An Open-label, Dose-escalation Study to Evaluate the Safety and Efficacy of Intravitreal EXG202 Injection in Patients with Wet (neovascular) Age-related Macular Degeneration (wAMD)', 'orgStudyIdInfo': {'id': 'EXG202-011'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Dose escalation-Cohort A', 'description': 'Dose 1 :Administered via intravitreal injection', 'interventionNames': ['Biological: EXG202']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental: Dose escalation-Cohort B', 'description': 'Dose 2 :Administered via intravitreal injection', 'interventionNames': ['Biological: EXG202']}], 'interventions': [{'name': 'EXG202', 'type': 'BIOLOGICAL', 'description': 'EXG202 is a gene therapy product for the treatment of wet (neovascular) age-related macular degeneration（wAMD） with a single intravitreal injection and administration.', 'armGroupLabels': ['Experimental: Dose escalation-Cohort A', 'Experimental: Dose escalation-Cohort B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '054001', 'city': 'Xingtai', 'state': 'Hebei', 'country': 'China', 'contacts': [{'name': 'Lifei Wang, Ph.D', 'role': 'CONTACT', 'email': 'wlfhb@126.com', 'phone': '13801057408'}], 'facility': 'Hebei Eye Hospital', 'geoPoint': {'lat': 37.06217, 'lon': 114.49272}}, {'zip': '322000', 'city': 'Yiwu', 'state': 'Zhejiang', 'country': 'China', 'contacts': [{'name': 'Yongming Zhang, Ph.D', 'role': 'CONTACT', 'email': 'zymcool@zju.edu.cn'}], 'facility': 'The Fourth Affiliated Hospital of Zhejiang University School of Medicine', 'geoPoint': {'lat': 29.31506, 'lon': 120.07676}}], 'centralContacts': [{'name': 'Sara Yang', 'role': 'CONTACT', 'email': 'sarayang@exegenesisbio.com', 'phone': '13957164092'}, {'name': 'Lifei Wang, Ph.D', 'role': 'CONTACT'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hangzhou Jiayin Biotech Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}