Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:37 PM
Study NCT ID:
NCT05301751
Status:
COMPLETED
Last Update Posted:
2025-10-15
First Post:
2022-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Single Ascending Dose Cohort Study of AG-73305 in DME Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}}}}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'tan.nguyen@allgenesis.com', 'phone': '+886-2-87871232', 'title': 'Tan Nguyen, Vice President of R&D', 'phoneExt': '105', 'organization': 'Allgenesis Biotherapeutics Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'Study was designed to assess safety, and efficacy endpoints were not statistically powered. Results should be interpreted with caution.'}}, 'adverseEventsModule': {'timeFrame': '6 months (24 weeks)', 'eventGroups': [{'id': 'EG000', 'title': 'Cohort 1', 'description': 'A single intravitreal (IVT) dose of 0.5 mg AG-73305', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cohort 2', 'description': 'A single IVT dose of 1 mg AG-73305', 'otherNumAtRisk': 6, 'deathsNumAtRisk': 6, 'otherNumAffected': 4, 'seriousNumAtRisk': 6, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Cohort 3', 'description': 'A single IVT dose of 2 mg AG-73305', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 6, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Cohort 4', 'description': 'A single IVT dose of 4 mg AG-73305', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Iridocyclitis (drug related)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 4}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vitreous haemorrhage', 'notes': 'The Investigator reported that the event was not related to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Diabetic retinopathy', 'notes': 'The Investigator reported that the event was not related to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Vitreous detachment', 'notes': 'The Investigator reported that the event was not related to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'anterior chamber inflammation', 'notes': 'The Investigator reported that the event was not related to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Iridocylitis', 'notes': 'The Investigator reported that the event was not related to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'seriousEvents': [{'term': 'Coronary artery disease', 'notes': 'The Investigator reported that the event was severe in intensity, and was unrelated to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Kidney failure', 'notes': 'The Investigator reported that the event was severe in intensity, and was unrelated to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Acute respiratory failure with hypoxia', 'notes': 'The Investigator reported that the event was severe in intensity, and was unrelated to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}, {'term': 'Congestive heart failure excerbation', 'notes': 'The Investigator reported that the event was severe in intensity, and was unrelated to AG-73305.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 25.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'A single intravitreal (IVT) dose of 0.5 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'A single IVT dose of 1 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'A single IVT dose of 2 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'A single IVT dose of 4 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '3.7', 'spread': '1.2', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '5.3', 'groupId': 'OG001'}, {'value': '4.3', 'spread': '3.9', 'groupId': 'OG002'}, {'value': '7.7', 'spread': '7.7', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month after dosing', 'description': 'BCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Subfield Thickness (CST)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}, {'units': 'eyes', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}, {'value': '8', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Cohort 1', 'description': 'A single intravitreal (IVT) dose of 0.5 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG001', 'title': 'Cohort 2', 'description': 'A single IVT dose of 1 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG002', 'title': 'Cohort 3', 'description': 'A single IVT dose of 2 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'OG003', 'title': 'Cohort 4', 'description': 'A single IVT dose of 4 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}], 'classes': [{'categories': [{'measurements': [{'value': '2.287', 'spread': '9.819', 'groupId': 'OG000'}, {'value': '-263.167', 'spread': '221.986', 'groupId': 'OG001'}, {'value': '-70.443', 'spread': '175.147', 'groupId': 'OG002'}, {'value': '-50.571', 'spread': '108.694', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 month after dosing', 'description': 'SD-OCT imaging was performed at all visits utilizing Heidelberg Spectralis imaging equipment to assess changes over time in the structural details of the posterior segment of the eye. All images were graded by a central reading center.', 'unitOfMeasure': 'μm', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'eyes', 'denomUnitsSelected': 'eyes'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Cohort 1', 'description': 'A single intravitreal (IVT) dose of 0.5 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'FG001', 'title': 'Cohort 2', 'description': 'A single IVT dose of 1 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'FG002', 'title': 'Cohort 3', 'description': 'A single IVT dose of 2 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'FG003', 'title': 'Cohort 4', 'description': 'A single IVT dose of 4 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '8'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '7'}, {'groupId': 'FG003', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Patients were screened based on the inclusion/exclusion criteria at 6 clinical sites in the US between May 2022 to December 2023.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Cohort 1', 'description': 'A single intravitreal (IVT) dose of 0.5 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'BG001', 'title': 'Cohort 2', 'description': 'A single IVT dose of 1 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'BG002', 'title': 'Cohort 3', 'description': 'A single IVT dose of 2 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'BG003', 'title': 'Cohort 4', 'description': 'A single IVT dose of 4 mg AG-73305\n\nAG-73305: AG-73305 Ophthalmic Solution'}, {'id': 'BG004', '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'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '15', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '10', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '70', 'spread': '3.6', 'groupId': 'BG000'}, {'value': '64.2', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '59.6', 'spread': '11.2', 'groupId': 'BG002'}, {'value': '54.5', 'spread': '14.7', 'groupId': 'BG003'}, {'value': '60.3', 'spread': '12.2', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '11', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '14', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '9', 'groupId': 'BG004'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '25', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Best-corrected Visual Acuity', 'classes': [{'categories': [{'measurements': [{'value': '56.7', 'spread': '1.5', 'groupId': 'BG000'}, {'value': '48.7', 'spread': '11.9', 'groupId': 'BG001'}, {'value': '62.4', 'spread': '5.4', 'groupId': 'BG002'}, {'value': '63.0', 'spread': '3.2', 'groupId': 'BG003'}, {'value': '58.6', 'spread': '8.8', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'ETDRS letters', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Central Subfield Thickness', 'classes': [{'categories': [{'measurements': [{'value': '522.017', 'spread': '197.845', 'groupId': 'BG000'}, {'value': '657.732', 'spread': '169.990', 'groupId': 'BG001'}, {'value': '444.818', 'spread': '163.635', 'groupId': 'BG002'}, {'value': '464.488', 'spread': '140.934', 'groupId': 'BG003'}, {'value': '511.475', 'spread': '174.539', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'micrometers', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-12-27', 'size': 488970, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2025-07-01T05:18', 'hasProtocol': True}, {'date': '2023-05-02', 'size': 10321105, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2025-07-01T05:19', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-05-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2023-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-29', 'studyFirstSubmitDate': '2022-03-20', 'resultsFirstSubmitDate': '2025-07-08', 'studyFirstSubmitQcDate': '2022-03-20', 'lastUpdatePostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-29', 'studyFirstPostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Change From Baseline in Best Corrected Visual Acuity (BCVA)', 'timeFrame': '1 month after dosing', 'description': 'BCVA assessments were performed at all visits utilizing ETDRS charts to assess changes in vision over time. The charts were designed for use at 4 meters. BCVA assessments were performed by certified technicians to minimize bias.'}], 'secondaryOutcomes': [{'measure': 'Mean Change From Baseline in Central Subfield Thickness (CST)', 'timeFrame': '1 month after dosing', 'description': 'SD-OCT imaging was performed at all visits utilizing Heidelberg Spectralis imaging equipment to assess changes over time in the structural details of the posterior segment of the eye. All images were graded by a central reading center.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Allegenesis', 'Diabetic Macular Edema', 'AG-73305'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This is a multi-centered, open-labeled, single ascending-dose-cohort study to evaluate the safety and efficacy of 4 dose cohorts of AG-73305 administered by intravitreal injection in patients with diabetic macular edema (DME).\n\nThe objectives of this study were to evaluate the safety, tolerability, duration of effect, systemic pharmacokinetic and immunogenicity profiles of ascending doses of AG-73305 administered by intravitreal injection to patients with DME. Pharmacodynamic endpoints (e.g., best-corrected visual acuity \\[BCVA\\], spectral domain optical coherence tomography \\[SD-OCT\\], and optical coherence tomography angiography \\[OCT-A\\]) were evaluated over 6 months post-treatment. The maximum tolerated dose or the highest administered dose was evaluated for future studies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or female, 18 years of age or older at the screening visit\n2. Prior diagnosis of diabetes mellitus (Type 1 or Type 2) as defined by World Health Organization or American Diabetes Association\n3. Presence of center-involving DME in the study eye with CST ≥ 325 μm\n4. Visual acuity loss in the study eye attributed to DME with screening and baseline ETDRS BCVA letter score of 20 to 55 (20/400 to 20/80 Snellen equivalent) in the sentinel patients and 35 to 70 (20/200 to 20/40 Snellen equivalent) in the non-sentinel patients\n5. Cohort 1: Previously treated with an anti-VEGF in the study eye; Cohorts 2, 3, and 4: Previously treated or treatment-naïve to the study eye\n\nExclusion Criteria:\n\n1. Uncontrolled diabetes mellitus, defined as hemoglobin A1c \\> 12.0% at Screening\n2. Uncontrolled hypertension with systolic blood pressure ≥ 180 mmHg and/or diastolic blood pressure ≥ 100 mmHg at Screening or Baseline\n3. Chronic renal disease\n4. Any active infection in either eye\n5. Any anti-vascular endothelial growth factor (VEGF) treatment in the study eye within 6 to 8 weeks prior to Baseline\n6. Use of Ozurdex (dexamethasone) within 6 months prior to Baseline or any use of Iluvien (fluocinolone acetonide) in the study eye\n7. Uncontrolled intraocular pressure (IOP), defined as an IOP \\> 25 mmHg, despite anti-glaucoma medications in the study eye at the time of screening or controlled glaucoma that requires management with \\> 2 topical hypotensive medications\n8. Any anti-integrin therapy (e.g., Xiidra) within 60 days before baseline in the study eye'}, 'identificationModule': {'nctId': 'NCT05301751', 'briefTitle': 'A Single Ascending Dose Cohort Study of AG-73305 in DME Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allgenesis Biotherapeutics Inc.'}, 'officialTitle': 'A Multicenter, Open-Labeled, Phase 2a Study Evaluating the Safety, Tolerability, and Efficacy of Intravitreal AG-73305 in Patients With Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'P2-73305-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cohort 1', 'description': '0.5 mg AG-73305 solution, single injection.', 'interventionNames': ['Biological: AG-73305']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 2', 'description': '1 mg AG-73305 solution, single injection.', 'interventionNames': ['Biological: AG-73305']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 3', 'description': '2 mg AG-73305 solution, single injection.', 'interventionNames': ['Biological: AG-73305']}, {'type': 'EXPERIMENTAL', 'label': 'Cohort 4', 'description': '4 mg AG-73305 solution, single injection.', 'interventionNames': ['Biological: AG-73305']}], 'interventions': [{'name': 'AG-73305', 'type': 'BIOLOGICAL', 'description': 'drug product solution', 'armGroupLabels': ['Cohort 1', 'Cohort 2', 'Cohort 3', 'Cohort 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '33711', 'city': 'St. Petersburg', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Vitreous Associates of Florida', 'geoPoint': {'lat': 27.77086, 'lon': -82.67927}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Center of Macula and Retina Disease', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '79606', 'city': 'Abilene', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Research Institute of Texas', 'geoPoint': {'lat': 32.44874, 'lon': -99.73314}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78503', 'city': 'McAllen', 'state': 'Texas', 'country': 'United States', 'facility': 'Valley Retina Institute', 'geoPoint': {'lat': 26.20341, 'lon': -98.23001}}, {'zip': '76087', 'city': 'Willow Park', 'state': 'Texas', 'country': 'United States', 'facility': 'Strategic Clinical Research Group, LLC', 'geoPoint': {'lat': 32.76263, 'lon': -97.65058}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allgenesis Biotherapeutics Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Lexitas Pharma Services, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}