Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2026-02-25 @ 8:16 PM
Study NCT ID:
NCT07053358
Status:
RECRUITING
Last Update Posted:
2025-07-11
First Post:
2025-06-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-07-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2029-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-08', 'studyFirstSubmitDate': '2025-06-27', 'studyFirstSubmitQcDate': '2025-06-27', 'lastUpdatePostDateStruct': {'date': '2025-07-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-11-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Adverse events and serious adverse events in the eyes and throughout the body within 364 days after LX111 treatment', 'timeFrame': '52 weeks', 'description': 'Incidence of adverse events and serious adverse events within 52 weeks of LX111 intravitreal injection in each dose group.'}, {'measure': 'Dose Limiting Toxicity', 'timeFrame': '4 weeks', 'description': 'The incidence of DLT in each dose group.'}], 'secondaryOutcomes': [{'measure': 'Mean changes in BCVA from Baseline', 'timeFrame': '12 weeks, 36 weeks, 52 weeks', 'description': 'The mean changes of BCVA scores on the ETDRS chart at different timepoints after LX111 treatment compared with baseline.'}, {'measure': 'Mean changes in Central Subfield Thickness (CST) from Baseline', 'timeFrame': '12 weeks, 36 weeks, 52 weeks', 'description': 'The mean changes of CST at different timepoints after LX111 treatment compared with baseline.'}, {'measure': 'The percentage of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment', 'timeFrame': '52 weeks', 'description': 'The proportion of subjects who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and efficacy of LX111 treatment of nAMD. This study will enroll subjects aged ≥ 50 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits.\n2. Age ≥ 50\n3. Diagnosis of active CNV secondary to neovascular AMD\n4. BCVA ETDRS letters between 5 and 63\n5. Subjects must have received a minimum of 2 injections within 6 months prior to screening and demonstrated a meaningful response to anti-VEGF therapy\n6. Male subjects whose partner is a fertile female or female subjects who are fertile, agree to take effective contraceptive measures from the screening period until the last follow-up.\n\nExclusion Criteria:\n\n1. CNV or macular edema in the study eye secondary to diseases other than nAMD\n2. Retinal detachment, uveitis, uncontrolled glaucoma in the study eye, or any condition preventing visual acuity improvement\n3. Acute coronary syndrome, myocardial infarction or coronary artery revascularization, CVA, TIA in the last 6 months\n4. Uncontrolled hypertension defined as average SBP ≥160 mmHg or an average DBP ≥100 mmHg\n5. Uncontrolled diabetes defined as HbA1c \\>8.0% within 28 days prior to screening'}, 'identificationModule': {'nctId': 'NCT07053358', 'briefTitle': 'Safety and Efficacy Evaluation of LX111 Gene Therapy in nAMD Patients', 'organization': {'class': 'OTHER', 'fullName': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}, 'officialTitle': 'An Exploratory Clinical Study Evaluating LX111 Gene Therapy in Patients With Neovascular Age-related Macular Degeneration (nAMD)', 'orgStudyIdInfo': {'id': 'SHGH-LX111'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LX111 intravitreal injections', 'interventionNames': ['Genetic: LX111 Injection']}], 'interventions': [{'name': 'LX111 Injection', 'type': 'GENETIC', 'description': 'Qualified subjects will receive a single unilateral intravitreal injection of LX111 at Day 0.', 'armGroupLabels': ['LX111 intravitreal injections']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanyuan Gong', 'role': 'CONTACT', 'email': 'gyydr@126.com', 'phone': '+86 02136126254'}], 'facility': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Innostellar Biotherapeutics Co.,Ltd', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Xiaodong Sun', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}