Ignite Creation Date:
2025-12-24 @ 5:32 PM
Ignite Modification Date:
2025-12-28 @ 8:49 PM
Study NCT ID:
NCT04612868
Status:
COMPLETED
Last Update Posted:
2023-08-01
First Post:
2020-10-28
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'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': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'info@aeyehealth.com', 'phone': '8662627343', 'title': 'Zack Dvey-Aharon, PhD', 'organization': 'AEYE Health Inc.'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Since this study was non-interventional with regards to the AEYE-DS device (i.e., it did not come in contact with the study participants) and all interventions were conventional screening exams with FDA-cleared devices used to obtain all of the ophthalmic examinations, information about adverse events was not collected. No safety assessments were necessary.', 'description': 'Since this study was non-interventional with regards to the AEYE-DS device (i.e., it did not come in contact with the study participants) and all interventions were conventional screening exams with FDA-cleared devices used to obtain all of the ophthalmic examinations, information about adverse events was not collected. No safety assessments were necessary.', 'eventGroups': [{'id': 'EG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '92.98', 'groupId': 'OG000', 'lowerLimit': '83.3', 'upperLimit': '97.24'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '91.36', 'groupId': 'OG000', 'lowerLimit': '88.22', 'upperLimit': '93.72'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Completed subjects with valid ground truth and AEYE-DS results'}, {'type': 'SECONDARY', 'title': 'Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'classes': [{'title': 'Sensitivity', 'categories': [{'measurements': [{'value': '94.74', 'groupId': 'OG000', 'lowerLimit': '85.63', 'upperLimit': '98.19'}]}]}, {'title': 'Specificity', 'categories': [{'measurements': [{'value': '88.64', 'groupId': 'OG000', 'lowerLimit': '85.18', 'upperLimit': '91.38'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity of the AEYE-DS device to detect mtmDR from digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on four images (one macula centered image and one optic disc centered image per eye). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'completed subjects with valid ground truth and AEYE-DS results'}, {'type': 'SECONDARY', 'title': 'Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '462', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'classes': [{'categories': [{'measurements': [{'value': '99.1', 'groupId': 'OG000', 'lowerLimit': '97.8', 'upperLimit': '99.7'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '1 day', 'description': 'To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.', 'unitOfMeasure': 'percentage of participants', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'screened and enrolled', 'groupId': 'FG000', 'numSubjects': '531'}]}, {'type': 'Analyzable', 'achievements': [{'groupId': 'FG000', 'numSubjects': '468'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'participants included in statistical analysis with fully analyzable data with valid ground truth (based on worst eye analysis) and AEYE-DS results output per participant.', 'groupId': 'FG000', 'numSubjects': '462'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '69'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '468', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.\n\nAEYE Software Device: Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and OCT images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '55', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '88'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '246', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '222', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '138', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '329', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '9', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '132', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '323', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '440', 'groupId': 'BG000'}]}]}, {'title': 'Israel', 'categories': [{'measurements': [{'value': '28', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Full Analysis (FA) Set - includes all eligible patients who were enrolled in and completed the study with analyzable data'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-24', 'size': 1776272, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-05-23T08:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 531}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2021-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-07-10', 'studyFirstSubmitDate': '2020-10-28', 'resultsFirstSubmitDate': '2023-05-23', 'studyFirstSubmitQcDate': '2020-10-28', 'lastUpdatePostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-07-10', 'studyFirstPostDateStruct': {'date': '2020-11-03', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-11-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Sensitivity and Specificity, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity of the AEYE-DS device to detect mtmDR on digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on two macula-centered images (one image from each eye of the patient). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.'}], 'secondaryOutcomes': [{'measure': 'Sensitivity and Specificity, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)', 'timeFrame': '1 day', 'description': 'Sensitivity and specificity of the AEYE-DS device to detect mtmDR from digital funduscopic images, acquired by the Topcon NW400 fundoscopy device, based on four images (one macula centered image and one optic disc centered image per eye). Sensitivity and specificity were calculated by comparing the output results of the AEYE-DS device to the ground truth (diagnostic determination by an independent, blinded panel of expert ophthalmologists at a reading center). The worst of two eyes was compared with the AEYE-DS output at the participant level.'}, {'measure': 'Imageability, Based on Two Macula-centered Images (One Image From Each Eye of the Patient)', 'timeFrame': '1 day', 'description': 'To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.'}, {'measure': 'Imageability, Based on Four Images (One Macula Centered Image and One Optic Disc Centered Image Per Eye)', 'timeFrame': '1 day', 'description': 'To assess the imageability of AEYE-DS, defined as the percentage of participants with a diagnostic output (positive for more than mild DR or negative for more than mild DR) from the AEYE-DS device. Participants with no diagnostic output (i.e., AEYE-DS output of "Insufficient Quality") lowers the imageability of the AEYE-DS.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Diabetes Mellitus', 'Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'AEYE-DS is a software device developed to increase compliance with diabetic retinopathy screening by automatically detecting more-than-mild diabetic retinopathy from digital fundus images using Artificial Intelligence (AI)-based software. This study has been designed to validate the safety and efficacy of the device at primary care and other point of care sites.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥22\n* Male or female\n* Documented diagnosis of diabetes mellitus, meeting the criteria established by the American Diabetes Association (ADA) and World Health Organization (WHO).\n* Understand the study and volunteer to sign the informed consent\n\nExclusion Criteria:\n\n* Uncorrectable vision loss (e.g., with the use of eyeglasses), blurred vision, or floaters.\n* Diagnosed with macular edema, severe non-proliferative retinopathy, proliferative retinopathy, radiation retinopathy, or retinal vein occlusion.\n* History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.\n* Currently participating in another investigational eye study and actively receiving investigational product for Diabetic Retinopathy (DR) or Diabetic Macular Edema (DME).\n* Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation).\n* Participant is contraindicated for imaging by fundus imaging systems used in the study:\n\n 1. Participant is hypersensitive to light\n 2. Participant recently underwent photodynamic therapy (PDT)\n 3. Participant is taking medication that causes photosensitivity\n 4. Participant has a history of angle-closure glaucoma or narrow anterior chamber angles'}, 'identificationModule': {'nctId': 'NCT04612868', 'briefTitle': 'Efficacy and Safety of AEYE-DS Software Device for Automated Detection of Diabetic Retinopathy From Digital Fundus Images', 'organization': {'class': 'INDUSTRY', 'fullName': 'AEYE Health Inc'}, 'officialTitle': 'Pivotal Prospective Clinical Trial to Demonstrate the Efficacy and Safety of AEYE-DS Software Device for Automated Diabetic Retinopathy Detection From Digital Fundoscopic Images', 'orgStudyIdInfo': {'id': 'AEYE-DS-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AEYE Software Device', 'description': 'An AI software device (AEYE-DS) to be used as a diagnostic tool to assist primary care clinicians in screening for diabetic retinopathy using digital funduscopic images. The device automatically detects more than mild diabetic retinopathy (mtmDR) in adults diagnosed with diabetes who have not been previously diagnosed with diabetic retinopathy.', 'interventionNames': ['Device: AEYE Software Device']}], 'interventions': [{'name': 'AEYE Software Device', 'type': 'DEVICE', 'description': 'Eligible participants will undergo the following procedures:\n\n* Photographic imaging of each eye using a funduscopy camera device. Images obtained will be sent to the AEYE-DS software for analysis.\n* Additional photographic and Optical Coherence Tomography (OCT) images will be obtained using a second funduscopy/OCT camera device. Images obtained will be sent to a professional reading center for analysis.\n* All study subjects will have their pupils dilated using dilation drops.', 'armGroupLabels': ['AEYE Software Device']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40206', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'The Eye Care Institute', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AEYE Health Inc', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}