Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-04-01 @ 10:59 AM
Study NCT ID:
NCT07362927
Status:
RECRUITING
Last Update Posted:
2026-03-10
First Post:
2026-01-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy Evaluation of LX111 Gene Therapy in DME Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-03', 'completionDateStruct': {'date': '2031-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-09', 'studyFirstSubmitDate': '2026-01-15', 'studyFirstSubmitQcDate': '2026-01-15', 'lastUpdatePostDateStruct': {'date': '2026-03-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-09', '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 participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment', 'timeFrame': '52 weeks', 'description': 'The proportion of participants who received anti-VEGF supplemental injection within 52 weeks after LX111 treatment'}, {'measure': 'Proportion of participants achieving an improvement or worsening in DR in the study eye per the ETDRS-DRSS on ultra-wide field fundus photography.', 'timeFrame': '52 weeks', 'description': 'To evaluate the effect of LX111 on DR (ETDRS-DRSS) over time.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema (DME)']}, 'descriptionModule': {'briefSummary': 'The goal of this study is to evaluate the safety and efficacy of LX111 treatment of DME. This study will enroll participants aged ≥ 18 vears old to receive a single unilateral intravitreal (lVT) injection of LX111 to evaluate its safety and efficacy.', 'detailedDescription': 'This trial is a prospective, multicenter, dose-ranging trial to evaluate the safety and efficacy of LX111 in participants with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing to sign the informed consent, and willing to attend follow-up visits;\n2. Age ≥ 18;\n3. Type I or Type II diabetes mellitus with macular thickening secondary to DME involving the center of the fovea;\n4. CST ≥ 300 μm in the study eye at Screening;\n5. BCVA ETDRS letters between 19 and 73;\n6. Participants must have received anti-VEGF therapy within 12 months prior to screening and demonstrated a meaningful response;\n7. 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. Active proliferative diabetic retinopathy (PDR);\n2. Presence of iris neovascularization in the study eye at Screening;\n3. Retinal laser photocoagulation in the study eye within 3 months prior to Screening;\n4. Prior gene therapy in the study eye;\n5. The study eye has been treated with an intravitreal dexamethasone implant (Ozurdex®) within 6 months prior to Screening.\n6. Systemic anti-VEGF treatment within 3 months before Screening;\n7. Received an investigational drug, agent, device, or therapy (ocular or non-ocular) in the 3 months (or at least 5 half-lives, whichever is longer) prior to Screening;'}, 'identificationModule': {'nctId': 'NCT07362927', 'briefTitle': 'Safety and Efficacy Evaluation of LX111 Gene Therapy in DME 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 Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': 'LX111-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'LX111 Dose Escalation up to 2 dose levels', 'description': 'Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.', 'interventionNames': ['Genetic: LX111 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'LX111 Dose Expansion Dose 1', 'description': 'Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.', 'interventionNames': ['Genetic: LX111 Injection']}, {'type': 'EXPERIMENTAL', 'label': 'LX111 Dose Expansion Dose 2', 'description': 'Qualified participants will receive a single unilateral intravitreal injection of LX111 at Day 0.', 'interventionNames': ['Genetic: LX111 Injection']}], 'interventions': [{'name': 'LX111 Injection', 'type': 'GENETIC', 'description': 'LX111 is an rAAV gene therapy vector carrying a coding sequence for VEGF-trap.', 'armGroupLabels': ['LX111 Dose Escalation up to 2 dose levels', 'LX111 Dose Expansion Dose 1', 'LX111 Dose Expansion Dose 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Shanghai', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Li Su', 'role': 'CONTACT', 'email': 'li.su@shgh.cn', 'phone': '+86 02136126254'}, {'name': 'Li Su', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Shanghai', 'status': 'NOT_YET_RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yuanzhi Yuan', 'role': 'CONTACT', 'email': 'Yuan.yuanzhi@zs-hospital.sh.cn', 'phone': '+86 02164041990'}, {'name': 'Yuanzhi Yuan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Zhongshan Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Li Su', 'role': 'CONTACT', 'email': 'li.su@shgh.cn', 'phone': '+86 02136126254'}]}, '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': 'Professor', 'investigatorFullName': 'Xiaodong Sun', 'investigatorAffiliation': 'Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine'}}}}