Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-28 @ 3:27 PM
Study NCT ID:
NCT05885503
Status:
RECRUITING
Last Update Posted:
2023-09-05
First Post:
2023-05-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C533178', 'term': 'aflibercept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 316}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-06-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-30', 'studyFirstSubmitDate': '2023-05-19', 'studyFirstSubmitQcDate': '2023-05-30', 'lastUpdatePostDateStruct': {'date': '2023-09-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-06-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in BCVA at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'BCVA=best-corrected visual acuity; Measurement of visual acuity with Early Treatment Diabetic Retinopathy Study (ETDRS) charts at a starting distance of 4 meters'}], 'secondaryOutcomes': [{'measure': 'Average change in BCVA from baseline over the period week 40 through week 52', 'timeFrame': 'Baseline, weeks 40, 44, 48 and 52', 'description': 'For each subject, this endpoint is defined as the average of the changes from baseline to weeks 40, 44, 48 and 52'}, {'measure': 'Change from baseline in BCVA over time', 'timeFrame': 'Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'BCVA will be assessed at each visit'}, {'measure': 'Proportion of patients gaining >15, >10, >5, or >0 letters in BCVA from baseline at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Proportion of patients of gaining 4 types of letter counting in BCVA, respectively'}, {'measure': 'Proportion of patients avoiding a loss of >15, >10, >5, or >0 letters in BCVA from baseline at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Proportion of patients of reducing 4 types of letter counting in BCVA, respectively'}, {'measure': 'Change from baseline in CST at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'CST=central subfield thickness'}, {'measure': 'Mean change from baseline in CST over a period of week 40 through week 52', 'timeFrame': 'Baseline, weeks 40, 44, 48 and 52.', 'description': 'CST=central subfield thickness'}, {'measure': 'Change from baseline in CST over time', 'timeFrame': 'Baseline, weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52', 'description': 'The change of CST will be assessed from baseline to 52 weeks by every 4 week intervals'}, {'measure': 'Proportion of patients with absence of intraretinal fluid at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Proportion of patients whose intraretinal fluid are completely improved'}, {'measure': 'Proportion of patients with absence of subretinal fluid at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Proportion of patients whose subretinal fluid are completely improved'}, {'measure': 'Proportion of patients with absence of intraretinal fluid and subretinal fluid at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'Proportion of patients whose intraretinal fluid and subretinal fluid are both completely improved'}, {'measure': 'Proportion of patients with a >2-step or>3-step DRS worsening from baseline on ETDRS DRSS at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'DRSS=Diabetic Retinopathy Severity Scale'}, {'measure': 'Proportion of patients who develop new PDR or high risk PDR at Week 52', 'timeFrame': 'Baseline, week 52', 'description': 'PDR=proliferative diabetic retinopathy'}, {'measure': 'Incidence and severity of ocular adverse events and non-ocular adverse events', 'timeFrame': '0~52 weeks', 'description': 'during the study'}, {'measure': 'Plasma concentration of RC28-E over time', 'timeFrame': 'Baseline, weeks 16, 36 and 48', 'description': 'during the study'}, {'measure': 'Presence of ADAs during the study relative to the presence of ADAs at baseline', 'timeFrame': 'Baseline, weeks 12, 24, 36 and 52', 'description': 'during the study'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate efficacy and safety of RC28-E compared with Aflibercept in subjects with diabetic macular edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented diagnosed with type I or type II diabetes mellitus.\n* Hemoglobin A1c (HBA1c) of less than or equal to (≤) 10% within 2 months prior to Day 1.\n* Ability and willingness to undertake all scheduled visits and assessments.\n* The study eye must meet the following requirements:\n\n * macular thickening secondary to diabetic macular edema (DME) involving the center of the fovea.\n * decreased visual acuity attributable primarily to DME, the best corrected visual acuity (BCVA) 19 or more letters, 78 letters or less.\n\nExclusion Criteria:\n\n* The study eye with high risk of proliferative diabetic retinopathy.\n* The macular edema of the study eye is mainly caused by other diseases or factors other than DME.\n* Treatment with panretinal photocoagulation or macular laser within 3 months prior to Day 1 to the study eye.\n* Administration of IVT any other anti-VEGF drugs in the study eye within 3 months and/or in the other eye within 7 days prior to Day 1.\n* Any intraocular long-acting or sustained release corticosteroid treatment (e.g., dexamethasone intravitreal implant) in the study eye within 6 months prior to Day 1.\n* Active intraocular or periocular infection or active intraocular inflammation in either eye.\n* The study eye with poorly controlled glaucoma.\n* A history of idiopathic or autoimmune related uveitis in either eye.\n* History of stroke (cerebrovascular accident) or myocardial infarction within 6 months prior to Day 1.\n* Uncontrolled blood pressure, defined as a systolic value greater than (\\>)180 millimeters of mercury (mmHg) and/or a diastolic value \\>100 mmHg while a patient is at rest.\n* Currently pregnant or breastfeeding, or intend to become pregnant during the study.\n* Any current or history of ocular disease other than DME that may confound assessment of the macula or affect central vision in the study eye.\n* Any current ocular condition which, in the opinion of the investigator, is currently causing or could be expected to contribute to irreversible vision loss due to a cause other than DME in the study eye.\n* Other protocol-specified inclusion/exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05885503', 'briefTitle': 'Efficacy and Safety of RC28-E Versus Aflibercept in Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'RemeGen Co., Ltd.'}, 'officialTitle': 'A Phase III, Multicenter, Randomized, Double-blind, Active Controlled Trial of RC28-E Intravitreal Injection in Subjects With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': '28C005'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'RC-28E', 'description': 'RC-28E 2.0 mg will be initially intravitreal injected (IVT) 5 times at 4 week intervals from week 0 to week 16, then every 8 weeks until week 48.', 'interventionNames': ['Biological: RC-28E']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Aflibercept', 'description': 'Aflibercept 2.0mg will be received IVT once every 4 weeks for 5 consecutive times from week 0 to week 16, then once every 8 weeks till week 48.', 'interventionNames': ['Biological: Aflibercept']}], 'interventions': [{'name': 'RC-28E', 'type': 'BIOLOGICAL', 'description': 'Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.', 'armGroupLabels': ['RC-28E']}, {'name': 'Aflibercept', 'type': 'BIOLOGICAL', 'description': 'Ophthalmic solution for intravitreal injection administered as a 2.0mg/50 μL per dose.', 'armGroupLabels': ['Aflibercept']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100010', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Youxin Chen, M.D.', 'role': 'CONTACT', 'email': 'chenyouxinpumch@163.com', 'phone': '13801025972'}], 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Binghua Xiao', 'role': 'CONTACT', 'email': 'xiaosir522@163.com', 'phone': '86-010-58076833'}], 'overallOfficials': [{'name': 'Youxin Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking Union Medical College Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RemeGen Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}