Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2026-02-23 @ 8:31 PM
Study NCT ID:
NCT02472366
Status:
COMPLETED
Last Update Posted:
2015-09-16
First Post:
2015-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005446', 'term': 'Fluocinolone Acetonide'}], 'ancestors': [{'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013259', 'term': 'Steroids, Fluorinated'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pascale.massin@lrb.aphp.FR', 'phone': '0149 95 24 74', 'title': 'Professor Pascale Massin', 'organization': 'Hopital Lariboisiere'}, 'certainAgreement': {'restrictionType': 'LTE60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'The safety and tolerability of ILUVIEN was monitored over 12 months.', 'eventGroups': [{'id': 'EG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN', 'otherNumAtRisk': 6, 'otherNumAffected': 2, 'seriousNumAtRisk': 6, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN', 'otherNumAtRisk': 10, 'otherNumAffected': 3, 'seriousNumAtRisk': 10, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Intra-ocular pressure (30 mmHg)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Dislocated Shoulder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intra-ocular pressure (25mmHG)', 'notes': '1 event occurred in the fellow eye', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Intra-ocular pressure (28mmHg)', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'seriousEvents': [{'term': 'Stroke', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Cataract Surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 2, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}, {'term': 'Vitrectomy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 6, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 10, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Surgical and medical procedures', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 15.1'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Changes in Best Corrected Visual Acuity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'OG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'classes': [{'categories': [{'measurements': [{'value': '3.5', 'spread': '7.40', 'groupId': 'OG000'}, {'value': '0.9', 'spread': '15.79', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'description': 'Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.', 'unitOfMeasure': 'Best Corrected VA Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For the "Laser" arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN'}, {'type': 'SECONDARY', 'title': 'Changes in Intraocular Pressure (IOP)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'OG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.86', 'groupId': 'OG000'}, {'value': '2.9', 'spread': '6.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'for "laser" arm group, 6 patients enrolled with 7 eyes receiving ILUVIEN'}, {'type': 'SECONDARY', 'title': 'Changes in Central Subfield Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'OG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'classes': [{'categories': [{'measurements': [{'value': '-362.2', 'spread': '130.59', 'groupId': 'OG000'}, {'value': '-251.3', 'spread': '268.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'unitOfMeasure': 'microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For "Laser" arm group, there were 6 patients enrolled but 7 eyes treated'}, {'type': 'SECONDARY', 'title': 'Changes in Macular Volume', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'OG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.610', 'spread': '1.1979', 'groupId': 'OG000'}, {'value': '-1.137', 'spread': '3.4345', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'unitOfMeasure': 'mm^3', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For "laser" arm group, 6 patients were enrolled with 7 eyes receiving ILUVIEN'}, {'type': 'POST_HOC', 'title': 'Change in Best Corrected Visual Acuity From Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'units': 'Eyes', 'counts': [{'value': '7', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'OG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'classes': [{'categories': [{'measurements': [{'value': '5.6', 'spread': '8.70', 'groupId': 'OG000'}, {'value': '9.4', 'spread': '11.46', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'description': 'A subgroup analysis was performed in which only pseudophakic subjects were included. Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.', 'unitOfMeasure': 'Best Corrected VA Letter Score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'typeUnitsAnalyzed': 'Eyes', 'denomUnitsSelected': 'Participants', 'populationDescription': 'For the "Laser" arm group, 6 patients were enrolled and 7 eyes were treated with ILUVIEN'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'FG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': '6 subjects receiving ILUVIEN, 7 eyes receiving ILUVIEN', 'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'BG001', 'title': 'Laser and Anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy\n\nILUVIEN'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '66.65', 'spread': '9.014', 'groupId': 'BG000'}, {'value': '60.87', 'spread': '11.006', 'groupId': 'BG001'}, {'value': '63.04', 'spread': '10.398', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2015-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-14', 'studyFirstSubmitDate': '2015-06-10', 'resultsFirstSubmitDate': '2015-06-23', 'studyFirstSubmitQcDate': '2015-06-12', 'lastUpdatePostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2015-08-14', 'studyFirstPostDateStruct': {'date': '2015-06-15', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-09-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in Best Corrected Visual Acuity From Baseline', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration', 'description': 'Best Corrected Visual Acuity is measured using an ETDRS eye chart and is reported as the number of letters read correctly in the study and/or fellow eye.'}], 'secondaryOutcomes': [{'measure': 'Changes in Intraocular Pressure (IOP)', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration'}, {'measure': 'Changes in Central Subfield Thickness', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration'}, {'measure': 'Changes in Macular Volume', 'timeFrame': 'Change from Baseline to 12 months post ILUVIEN administration'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Chronic Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'A phase 4 trial evaluating the effect and safety of ILUVIEN in chronic DME patients insufficiently responsive to available therapies.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Patients ≥18 years of age, of either sex that have signed informed consent / been well informed by the treating physician.\n2. DME based on investigator's clinical evaluation and demonstrated using fundoscopic photography and spectral domain OCT.\n3. Mean central foveal thickness (central subfield thickness) ≥350 microns in the study eye as measured using spectral domain OCT.\n4. Vision impairment (20/60 to 20/400 using Snellen visual acuity equivalent) related to DME.\n5. Previous treatment in the study eye with laser photocoagulation for DME, including focal/grid and pan-retinal, at least 3 months prior to the screening visit and ≥3 monthly anti-VEGF treatments (group 1).\n6. Previous treatment in the study eye with laser photocoagulation for DME at least 3 months prior to the screening visit (group 2) and treatment with an intraocular anti-VEGF therapy not possible.\n7. Patients considered as insufficiently responsive to prior therapy for DME, as defined by the study physician.\n\nExclusion Criteria:\n\n1. IOP \\>21 mmHg at screening in the study eye.\n2. Historical rise in IOP \\>25 mmHg following treatment with an intravitreal corticosteroid in the study eye.\n3. Use of ≥2 IOP-lowering medications to control IOP at screening in the study eye.\n4. Patients that have vitreomacular traction in DME and opaque media in the study eye.\n5. Patients with severe proliferative diabetic retinopathy requiring pan retinal photocoagulation in the study eye.\n6. Pregnant or breastfeeding.\n7. Patients diagnosed with active angiographic central vein ischaemia prior to screening in the study eye.\n8. Patients that have received pan retinal photocoagulation or undergone cataract surgery in the 3 months prior to the study start date in the study eye.\n9. Patients with contraindications according to the current SPC:\n\n 1. The presence of pre-existing glaucoma.\n 2. Active or suspected ocular or periocular infection.\n 3. The patient is hypersensitive to the active agent or to one of the excipients."}, 'identificationModule': {'nctId': 'NCT02472366', 'briefTitle': 'A Non-Randomized, Open-Label, Single Center Phase 4 Study of the Effect and Safety of ILUVIEN® in Chronic Diabetic Macular Edema Patients Considered Insufficiently Responsive to Available Therapies (Laser, Anti-VEGF) With or Without Intravitreal Corticosteroid Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'ANI Pharmaceuticals'}, 'orgStudyIdInfo': {'id': 'M-01-13-002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'laser', 'description': 'laser with or without prior history of intraocular corticosteroid therapy', 'interventionNames': ['Drug: ILUVIEN']}, {'type': 'OTHER', 'label': 'laser and anti-VEGF', 'description': 'laser and anti-VEGF therapy with or without prior history of intraocular corticosteroid therapy', 'interventionNames': ['Drug: ILUVIEN']}], 'interventions': [{'name': 'ILUVIEN', 'type': 'DRUG', 'armGroupLabels': ['laser', 'laser and anti-VEGF']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alimera Sciences', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}