Ignite Creation Date:
2025-12-25 @ 4:17 AM
Ignite Modification Date:
2025-12-26 @ 3:17 AM
Study NCT ID:
NCT05038020
Status:
TERMINATED
Last Update Posted:
2023-11-01
First Post:
2021-07-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-03-15', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'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'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sm-Trials-alkahest@grifols.com', 'phone': '(650) 801-0474', 'title': 'Head of Communications', 'organization': 'Alkahest, Inc.'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'This study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on low enrollment number, no data is reported in order to protect and maintain participant privacy/confidentiality.'}}, 'adverseEventsModule': {'timeFrame': 'The planned timeframe for adverse event (AE) collection was from the first dose of the study drug until the post-treatment follow-up period (baseline to Week 28). However, the study was terminated early by the sponsor. At the time of termination, 3 participants were enrolled and none completed the study. Enrolled subjects had a safety visit at 30 and 60 days following study drug discontinuation.', 'description': 'Three participants were enrolled and none completed the study. All participants were allocated to randomized treatment with AKST4290, and no participants received placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 2, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Diabetes Mellitus', 'notes': 'Worsening of Diabetes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Vitreous floaters', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Activated partial thromboplastin time prolonged', 'notes': 'Elevated APTT on labs', 'stats': [{'groupId': 'EG000', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 0, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 24', 'description': 'The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.\n\nTo be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline.\n\nThe DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.\n\nThe primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}, {'type': 'SECONDARY', 'title': 'To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 24 or 28', 'description': 'The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.\n\nThe DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.\n\nThe secondary efficacy endpoint is the proportion of participants with a ≥ 2-step improvement from baseline on the DRSS score as compared with Week 24.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}, {'type': 'SECONDARY', 'title': 'To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the proportion of participants progressing to the following vision-threatening complications that require treatment: CI-DME, PDR, and/or ASNV as assessed by spectral domain optical coherence tomography (SD-OCT), fundus photography (FP), and fluorescein angiography (FA), as appropriate. The central reading center must confirm progression to CI-DME and PDR before treatment is initiated; progression to ASNV, and subsequent treatment, does not require photo documentation.', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}, {'type': 'SECONDARY', 'title': 'To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}, {'type': 'SECONDARY', 'title': 'To Assess the Overall Safety of AKST429', 'denoms': [{'units': 'Participants', 'counts': [{'value': '3', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'classes': [{'categories': [{'title': 'AE Intensity - Mild', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'AE Intensity - Moderate', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}, {'title': 'AE Intensity - Severe', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline to Week 28', 'description': 'Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated early by the Sponsor. At the time of discontinuation, three participants were enrolled, and all participants were allocated to randomized treatment with AKST4290.'}, {'type': 'SECONDARY', 'title': 'To Assess the Effect of AKST4290 on Diabetic Kidney Disease', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values over time (eg, estimated glomerular filtration rate \\[eGFR\\], urine albumin to creatinine ratio \\[UACR\\]).', 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}, {'type': 'SECONDARY', 'title': 'To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'OG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'timeFrame': 'Baseline to Week 24', 'description': "The WPAI-GH V2.0 is a 6-question survey used to assess the effects of a participant's health problems (i.e., physical or emotional problems or symptoms) on their ability to work and perform regular activities during the past seven days. The WPAI-GH questions will be analyzed as impairment percentages, in which higher percentages indicate greater impairment and less productivity.\n\nThe following parameters will be calculated (multiply scores by 100 to express in percentages):\n\n* Percent of work time missed due to health: Q2 divided by (Q2 plus Q4)\n* Percent of impairment while working due to health: Q5 divided by 10\n* Percent of overall work impairment due to health: Q2 divided by (Q2 plus Q4) plus \\[(1 - (Q2 divided by (Q2 plus Q4 ))) multiplied by (Q5 divided by 10)\\]\n* Percent of activity impairment due to health: Q6 divided by 10", 'reportingStatus': 'POSTED', 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'FG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Early Termination', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'The study was terminated early by the Sponsor. At the time of discontinuation, three participants were enrolled and none completed the study.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks\n\nAKST4290: Oral AKST4290'}, {'id': 'BG001', 'title': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks\n\nPlacebo: Oral Placebo'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years'}, {'title': 'Between 18 and 65 years'}, {'title': '>=65 years'}]}]}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female'}, {'title': 'Male'}]}]}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino'}, {'title': 'Not Hispanic or Latino'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native'}, {'title': 'Asian'}, {'title': 'Native Hawaiian or Other Pacific Islander'}, {'title': 'Black or African American'}, {'title': 'White'}, {'title': 'More than one race'}, {'title': 'Unknown or Not Reported'}]}]}, {'title': 'Diabetes Mellitus Type', 'classes': [{'title': 'Diabetes Mellitus 1'}, {'title': 'Diabetes Mellitus 2'}]}], 'populationDescription': 'The study was terminated by the Sponsor. Only 3 participants were enrolled in this study. Based on the low enrollment number, no data is reported here in order to protect and maintain participant privacy/confidentiality.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-08-19', 'size': 982329, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-02-16T01:11', 'hasProtocol': True}, {'date': '2022-06-02', 'size': 477019, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-02-16T01:12', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3}}, 'statusModule': {'whyStopped': 'Study terminated due to safety findings in other AKST4290 studies', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2022-04-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2021-07-29', 'resultsFirstSubmitDate': '2023-02-16', 'studyFirstSubmitQcDate': '2021-08-31', 'lastUpdatePostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-10-09', 'studyFirstPostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To Investigate the Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.', 'timeFrame': 'Baseline to Week 24', 'description': 'The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.\n\nTo be eligible for the study, participants needed to have moderately severe non-proliferative DR (NPDR) (DRSS Level 47) to severe NPDR (DRSS Level 53) in one eye, and at least mild NPDR (DRSS Level 35) to mild proliferative DR (PDR) (DRSS Level 61) in the other eye at baseline.\n\nThe DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.\n\nThe primary efficacy endpoint is the proportion of participants with a ≥ 3-step improvement from baseline on the DRSS score as compared with Week 24.'}], 'secondaryOutcomes': [{'measure': 'To Investigate Additional Measures of Efficacy of AKST4290 Assessed by the Improvement in the DRSS Score From Baseline.', 'timeFrame': 'Baseline to Week 24 or 28', 'description': 'The Diabetic Retinopathy Severity Scale (DRSS) divides DR into 13 levels ranging from the absence of retinopathy to severe retinopathy and is used to describe overall DR severity as well as the change in severity over time. Higher scores indicate more severe DR.\n\nThe DRSS score is derived from fundus photography (FP) and fluorescein angiography (FA) findings.\n\nThe secondary efficacy endpoint is the proportion of participants with a ≥ 2-step improvement from baseline on the DRSS score as compared with Week 24.'}, {'measure': 'To Assess the Proportion of Participants Progressing to (or Worsening of) Center-involved Diabetic Macular Edema (CI-DME), Proliferative Diabetic Retinopathy (PDR), and/or Anterior-segment Neovascularization (ASNV).', 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the proportion of participants progressing to the following vision-threatening complications that require treatment: CI-DME, PDR, and/or ASNV as assessed by spectral domain optical coherence tomography (SD-OCT), fundus photography (FP), and fluorescein angiography (FA), as appropriate. The central reading center must confirm progression to CI-DME and PDR before treatment is initiated; progression to ASNV, and subsequent treatment, does not require photo documentation.'}, {'measure': 'To Assess the Time to Event of CI-DME, PDR, and/or ASNV Requiring Treatment.', 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the time to the following vision-threatening event(s) that require treatment: CI-DME, PDR, and/or ASNV'}, {'measure': 'To Assess the Overall Safety of AKST429', 'timeFrame': 'Baseline to Week 28', 'description': 'Safety was assessed based on the number of participants who reported adverse events of mild, moderate or severe intensities.'}, {'measure': 'To Assess the Effect of AKST4290 on Diabetic Kidney Disease', 'timeFrame': 'Baseline to Week 28', 'description': 'The secondary efficacy endpoint is the effect of AKST4290 on diabetic kidney disease as assessed by changes in clinical laboratory values over time (eg, estimated glomerular filtration rate \\[eGFR\\], urine albumin to creatinine ratio \\[UACR\\]).'}, {'measure': 'To Evaluate the Changes From Baseline in the Workplace Productivity and Activity Impairment General Health (WPAI-GH) Questionnaire.', 'timeFrame': 'Baseline to Week 24', 'description': "The WPAI-GH V2.0 is a 6-question survey used to assess the effects of a participant's health problems (i.e., physical or emotional problems or symptoms) on their ability to work and perform regular activities during the past seven days. The WPAI-GH questions will be analyzed as impairment percentages, in which higher percentages indicate greater impairment and less productivity.\n\nThe following parameters will be calculated (multiply scores by 100 to express in percentages):\n\n* Percent of work time missed due to health: Q2 divided by (Q2 plus Q4)\n* Percent of impairment while working due to health: Q5 divided by 10\n* Percent of overall work impairment due to health: Q2 divided by (Q2 plus Q4) plus \\[(1 - (Q2 divided by (Q2 plus Q4 ))) multiplied by (Q5 divided by 10)\\]\n* Percent of activity impairment due to health: Q6 divided by 10"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CCR3 inhibition', 'Diabetic Retinopathy', 'Oral Treatment'], 'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants with Moderately Severe to Severe Diabetic Retinopathy (CAPRI).', 'detailedDescription': 'This study is designed to evaluate the efficacy of AKST4290 administered at a total daily dose (TDD) of 800 mg daily (400 mg twice daily \\[b.i.d.\\]) compared with placebo over a 24-week dosing period in participants with moderately severe non-proliferative diabetic retinopathy (NPDR) to severe NPDR.\n\nParticipants will be enrolled and allocated to 1 of 2 treatment arms in a 2:1 randomization scheme (AKST4290: placebo). Participants will receive treatment for a total of 24 weeks with either AKST4290 800 mg daily (400 mg b.i.d.) in Arm 1 or placebo (matching tablets) in Arm 2'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Age ≥ 18 years.\n2. Type 1 or type 2 DM.\n3. BCVA ETDRS visual acuity letter score≥ 69 letters at Screening.\n4. Moderately severe NPDR (DRSS Level 47) to severe NPDR (DRSS Level 53).\n\nExclusion Criteria:\n\n1. Evidence of neovascularization (NV) (including active iris or angle NV) requiring treatment, per investigator discretion.\n2. PRP or grid laser within 1000 microns of the foveal center.\n3. Center-InvolvedI-Diabetic Macular Edema (CI-DME) on clinical examination (CI is defined as DME within 1,000 microns of the foveal center).\n4. Prior Intraocular of periocular steroid Injection\n5. Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to enrollment and assignment to a randomized treatment.\n6. History of vitreoretinal surgery.\n7. History of major ocular surgery (including cataract extraction, scleral buckle, any intraocular surgery, etc.) within prior 4 months or anticipated within the next 6 months following randomization.\n8. History of DME or DR treatment with laser or intraocular injections of medication.\n9. Medical history or condition that, in the opinion of the investigator would preclude participation in the study.\n10. Clinically relevant abnormal laboratory value at Screening, including hematology, blood chemistry, or urinalysis (laboratory testing may be repeated once during the Screening phase).\n11. Malignancy for which the participant has undergone resection, radiation, or chemotherapy within the past 5 years (treated basal cell carcinoma or fully cured squamous cell carcinoma are allowed).\n12. Concurrent participation in another interventional clinical trial; prior clinical trial participants must have been off study agents for at least 30 days for small molecules, 4 months for disease modifying therapies, and 1 year for vaccine or immunotherapy trials prior to Screening.'}, 'identificationModule': {'nctId': 'NCT05038020', 'briefTitle': 'A Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alkahest, Inc.'}, 'officialTitle': 'A Double-Masked, Placebo-Controlled Study to Evaluate the Efficacy of Oral AKST4290 in Participants With Moderately Severe to Severe Diabetic Retinopathy (CAPRI)', 'orgStudyIdInfo': {'id': 'AKST4290-231'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AKST4290', 'description': 'Subjects will receive AKST4290, 400mg twice daily, for 24 weeks', 'interventionNames': ['Drug: AKST4290']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Subjects will receive matching Placebo, twice daily, for 24 weeks', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'AKST4290', 'type': 'DRUG', 'description': 'Oral AKST4290', 'armGroupLabels': ['AKST4290']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Oral Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85021', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 132', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '85053', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Site 136', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '91203', 'city': 'Glendale', 'state': 'California', 'country': 'United States', 'facility': 'Site 123', 'geoPoint': {'lat': 34.14251, 'lon': -118.25508}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Site 121', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '33761', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 116', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 117', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '33880', 'city': 'Winter Haven', 'state': 'Florida', 'country': 'United States', 'facility': 'Site 118', 'geoPoint': {'lat': 28.02224, 'lon': -81.73286}}, {'zip': '60452', 'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'Site 120', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}, {'zip': '29902', 'city': 'Beaufort', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site 133', 'geoPoint': {'lat': 32.4317, 'lon': -80.66993}}, {'zip': '29456', 'city': 'Ladson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Site 127', 'geoPoint': {'lat': 32.98573, 'lon': -80.10981}}, {'zip': '76012', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 122', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 130', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '78550', 'city': 'Harlingen', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 126', 'geoPoint': {'lat': 26.19063, 'lon': -97.6961}}, {'zip': '77025', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 134', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '77494', 'city': 'Katy', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 129', 'geoPoint': {'lat': 29.78579, 'lon': -95.8244}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Site 128', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '84107', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Site 125', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}], 'overallOfficials': [{'name': 'Alkahest Medical Monitor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alkahest, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alkahest, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}