Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:15 PM
Study NCT ID:
NCT04697758
Status:
TERMINATED
Last Update Posted:
2024-03-22
First Post:
2020-12-17
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2024-02-20', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D015785', 'term': 'Eye Diseases, Hereditary'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000708027', 'term': 'AXT107'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ashojaei@asclepix.com', 'phone': '8005723545', 'title': 'Dr A Shojaei', 'organization': 'AsclepiX Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '48 weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Low Dose', 'description': 'AXT107 0.1 mg/eye\n\nAXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 3}, {'id': 'EG001', 'title': 'Mid Dose', 'description': 'AXT107 0.25 mg/eye\n\nAXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 1, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Vitreous Floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 3, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'seriousEvents': [{'term': 'Ocular Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Gastroenteritis', 'notes': 'Non-Ocular', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Safety as Assessed by Incidence of Adverse Events (AEs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Dose', 'description': 'AXT107 0.1 mg/eye\n\nAXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye'}, {'id': 'OG001', 'title': 'Mid Dose', 'description': 'AXT107 0.25 mg/eye\n\nAXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye'}], 'classes': [{'title': 'Serious Ocular Adverse Event Treatment Related', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Serious Non-Ocular Adverse Event Not Related to treatment', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Screening to Week 48', 'description': 'Incidence of ocular (study eye) and systemic AEs', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low Dose', 'description': 'AXT107 0.1 mg/eye\n\nAXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye'}, {'id': 'FG001', 'title': 'Mid Dose', 'description': 'AXT107 0.25 mg/eye\n\nAXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye'}, {'id': 'FG002', 'title': 'High Dose', 'description': 'AXT107 0.5 mg/eye'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'No participants were assigned to the "High Dose" Arm/Group" due to adverse events observed in the "Low Dose" and "Mid Dose" groups.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low Dose', 'description': 'AXT107 0.1 mg/eye\n\nAXT107 0.1 mg: Single intravitreal injection of AXT107 0.1 mg/eye'}, {'id': 'BG001', 'title': 'Mid Dose', 'description': 'AXT107 0.25 mg/eye\n\nAXT107 0.25 mg: Single intravitreal injection of AXT107 0.25 mg/eye'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.3', 'groupId': 'BG000', 'lowerLimit': '55', 'upperLimit': '62'}, {'value': '73.3', 'groupId': 'BG001', 'lowerLimit': '71', 'upperLimit': '75'}, {'value': '65.8', 'groupId': 'BG002', 'lowerLimit': '55', 'upperLimit': '75'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}], 'populationDescription': 'Enrollment was closed after mid dose cohort were enrolled. The study only enrolled 6 subjects.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-08-31', 'size': 4207138, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-02-20T07:29', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'whyStopped': 'Adverse Events', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-20', 'studyFirstSubmitDate': '2020-12-17', 'resultsFirstSubmitDate': '2024-01-29', 'studyFirstSubmitQcDate': '2021-01-04', 'lastUpdatePostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-03-20', 'studyFirstPostDateStruct': {'date': '2021-01-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-03-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety as Assessed by Incidence of Adverse Events (AEs)', 'timeFrame': 'Screening to Week 48', 'description': 'Incidence of ocular (study eye) and systemic AEs'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['AsclepiX', 'macular edema', 'DME', 'eye diseases', 'retinal diseases', 'AXT107', 'diabetes', 'duration of action', 'dose escalation', 'diabetic retinopathy', 'retinal degeneration'], 'conditions': ['Diabetic Macular Edema (DME)']}, 'descriptionModule': {'briefSummary': 'This study is an open-label, dose-escalating, 48-week study assessing the safety, tolerability, bioactivity and duration of action of a single intravitreal injection of 0.1 mg, 0.25 mg, or 0.5 mg AXT107 in approximately 18 subjects (up to 6 subjects per dose) with Diabetic Macular Edema (DME).', 'detailedDescription': 'Upon providing informed consent, subjects will be sequentially enrolled into the study. Decision regarding dose escalation will be based on the recommendation from the Data Monitoring Committee (DMC). The first 3 eligible subjects will receive the low dose of AXT107 injection. After the 3 low dose subjects complete a 7-day follow-up, the DMC will review their safety data. If an acceptable safety profile is determined by the DMC, 3 additional subjects will be enrolled to receive the mid dose of AXT107 injection. Upon completion of a 7-day follow-up, review of the safety data, and determination of an acceptable safety profile by the DMC for the mid dose subjects, 3 additional subjects will be enrolled to receive the high dose of AXT107 injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older with diabetic macular edema (DME) diagnosis secondary to diabetes mellitus Type 1 or 2\n* Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score of 65 to 23 in the study eye\n* Willing and able to comply with clinic visits and study-related procedures\n* Provide signed inform consent\n\nExclusion Criteria:\n\n* Any signs of high risk proliferative diabetic retinopathy in the study\n* Previously-treated patients who are not responders to anti-VEGF\n* Panretinal laser photocoagulation within 6 months and macular laser photocoagulation with 3 months of screening in the study eye\n\nNote: Other inclusion/exclusion criteria apply.'}, 'identificationModule': {'nctId': 'NCT04697758', 'acronym': 'CONGO', 'briefTitle': 'Safety and Bioactivity of AXT107 in Subjects With Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'AsclepiX Therapeutics, Inc.'}, 'officialTitle': 'Phase 1/2a Study of the Safety and Bioactivity of AXT-107 in Subjects With Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': 'AXT107-CS101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low Dose', 'description': 'AXT107 0.1 mg/eye', 'interventionNames': ['Drug: AXT107 0.1 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Mid Dose', 'description': 'AXT107 0.25 mg/eye', 'interventionNames': ['Drug: AXT107 0.25 mg']}, {'type': 'EXPERIMENTAL', 'label': 'High Dose', 'description': 'AXT107 0.5 mg/eye', 'interventionNames': ['Drug: AXT107 0.5 mg']}], 'interventions': [{'name': 'AXT107 0.1 mg', 'type': 'DRUG', 'otherNames': ['Gersizangatide'], 'description': 'Single intravitreal injection of AXT107 0.1 mg/eye', 'armGroupLabels': ['Low Dose']}, {'name': 'AXT107 0.25 mg', 'type': 'DRUG', 'otherNames': ['Gersizangatide'], 'description': 'Single intravitreal injection of AXT107 0.25 mg/eye', 'armGroupLabels': ['Mid Dose']}, {'name': 'AXT107 0.5 mg', 'type': 'DRUG', 'otherNames': ['Gersizangatide'], 'description': 'Single intravitreal injection of AXT107 0.5 mg/eye', 'armGroupLabels': ['High Dose']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85053', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '90211', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '78550', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '77384', 'city': 'The Woodlands', 'state': 'Texas', 'country': 'United States', 'facility': 'AsclepiX Investigative Site', 'geoPoint': {'lat': 30.15799, 'lon': -95.48938}}], 'overallOfficials': [{'name': 'Amir Shojaei, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Asclepix Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AsclepiX Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}