Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT05489718
Status:
COMPLETED
Last Update Posted:
2023-10-27
First Post:
2022-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-25', 'studyFirstSubmitDate': '2022-06-21', 'studyFirstSubmitQcDate': '2022-08-03', 'lastUpdatePostDateStruct': {'date': '2023-10-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety evaluation indicators', 'timeFrame': 'Through study completion, a maximum of 24 weeks', 'description': 'Incidence, relatedness and severity of all adverse events, treatment emergent adverse events and serious adverse events b) Changes in central subfield thickness by OCT compared with baseline'}], 'secondaryOutcomes': [{'measure': 'The incidence of adverse events', 'timeFrame': 'Through study completion, a maximum of 24 weeks'}, {'measure': 'Changes in visual acuity as measured by BCVA compared with baseline', 'timeFrame': 'Through study completion, a maximum of 24 week'}, {'measure': 'Changes in the average thickness of the macula in the central 1 mm ETDRS grid (CST) compared with baseline', 'timeFrame': 'Through study completion, a maximum of 24 week'}, {'measure': 'Pharmacokinetic (PK) profiles, such as half-life time (t1/2)，etc', 'timeFrame': 'Through study completion, a maximum of 24 weeks', 'description': 'Positive rate of anti-drug antibody'}, {'measure': 'Immunogenicity evaluation indicators', 'timeFrame': 'Through study completion, a maximum of 24 weeks', 'description': 'Positive rate of anti-drug antibody'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This study is designed as a Multi-center, open-label, dose escalation phase I trial to evaluate the safety and tolerability of a single and multiple intravitreal injections of IBI324 in subjects with DME'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Willing and able to sign informed consent form and comply with visit and study procedures per protocol.\n2. Male or female subjects with age of 18\\~80 yrs.\n3. Diagnosis of diabetes mellitus(type 1 or 2), and current regular use of insulin or other injectable drugs or oral anti-hyperglycaemic agent for the treatment of diabetes.\n4. Visual impairment was caused by DME involving the macular fovea.\n5. Central macular sub-field thickness (CST) ≥320μm according to OCT.\n6. BCVA score of 24-73 letters using ETDRS charts (in 4 meters) in the study eye.\n7. Female subjects of childbearing age or male subjects with childbearing age female partner agree to take effective contraceptive measures from the screening period to 3 months after the end of treatment.\n\nExclusion Criteria:\n\n1. Concomitant diseases that may cause subjects fail to respond to the treatment or confuse the interpretation of the study results.\n2. PDR in the study eye.\n3. Tractional retinal detachment, pre-retinal fibrosis, vitreomacular traction, or epiretinal membrane involving the fovea or disrupting the macular architecture in the study eye.\n4. Active rubeosis in the study eye.\n5. The equivalent spherical lens≤-8.00D in the study eye.\n6. The intraocular pressure\\>21 mmHg in the study eye.\n7. Active ocular or periocular inflammation/infection in either eye.\n8. Prior any treatment of following in the study eye:\n\n * Intravitreal anti-VEGF treatment within 3 months prior to baseline;\n * Intraocular glucocorticoid injection within 3 months prior to baseline;\n * PRP, local/grid laser photocoagulation within 3 months prior to baseline;\n * Any intraocular surgery (e.g. cataract surgery) within 90 days prior to baseline;\n * The eyes were treated with lasik posterior capsulotomy or glaucoma filtration, radiotherapy 30 days before baseline;\n9. Currently untreated diabetes mellitus or previously untreated DM subjects who initiated oral or injectable antidiabetic medication or insulin \\<90 days;\n10. HbA1c of \\>10% within 28 days prior to baseline;\n11. Presence of any systemic disease: including but not limited to unstable angina; cerebrovascular accident or transient cerebral ischemia (within 6 months prior to selection); myocardial infarction (within 6 months prior to selection); serious arrhythmia requiring medical treatment; liver, kidney or metabolic diseases; or malignant tumor;\n12. History of severe hypersensitivity/allergy to active ingredients or any excipients of the study drug, or fluorescein and povidone iodine;\n13. Pregnant or lactating women or women preparing to become pregnant or breastfeeding during the study period;\n14. Participated in any clinical study of any other drug within three months prior to enrollment, or attempted to participate in other drug trials during the study;\n15. Other conditions unsuitable for enrollment judged by investigators'}, 'identificationModule': {'nctId': 'NCT05489718', 'briefTitle': 'A Dose Escalation Study of IBI324 in Subjects With Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Innovent Biologics (Suzhou) Co. Ltd.'}, 'officialTitle': 'A Dose Escalation Phase I Clinical Study to Evaluate the Tolerability and Safety of IBI324 in Subjects With Diabetic Macular Edema(DME)', 'orgStudyIdInfo': {'id': 'CIBI324A101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'treated with different doses of single intravitreal inmection of IBI324', 'interventionNames': ['Biological: IBI324']}, {'type': 'EXPERIMENTAL', 'label': 'treated with different doses of multiple intravitreal inmection of IBI324', 'interventionNames': ['Biological: IBI324']}], 'interventions': [{'name': 'IBI324', 'type': 'BIOLOGICAL', 'description': 'Dose 2 IBI324 of multiple IVT injection', 'armGroupLabels': ['treated with different doses of multiple intravitreal inmection of IBI324']}, {'name': 'IBI324', 'type': 'BIOLOGICAL', 'description': 'Dose 2 IBI324 of single IVT injection', 'armGroupLabels': ['treated with different doses of single intravitreal inmection of IBI324']}, {'name': 'IBI324', 'type': 'BIOLOGICAL', 'description': 'Dose 1 IBI324 of single IVT injection', 'armGroupLabels': ['treated with different doses of single intravitreal inmection of IBI324']}, {'name': 'IBI324', 'type': 'BIOLOGICAL', 'description': 'Dose 3 IBI324 of single IVT injection', 'armGroupLabels': ['treated with different doses of single intravitreal inmection of IBI324']}, {'name': 'IBI324', 'type': 'BIOLOGICAL', 'description': 'Dose 3 IBI324 of multiple IVT injection', 'armGroupLabels': ['treated with different doses of multiple intravitreal inmection of IBI324']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200080', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Shanghai General Hospital', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Innovent Biologics (Suzhou) Co. Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}