Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2026-03-13 @ 3:08 AM
Study NCT ID:
NCT02732951
Status:
COMPLETED
Last Update Posted:
2019-03-20
First Post:
2016-04-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Centre', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'otherDetails': "Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first drug administration until 4 days after last drug administration, up to 89 days.', 'eventGroups': [{'id': 'EG000', 'title': 'Placebo Matching to BI 1026706', 'description': 'Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.', 'otherNumAtRisk': 53, 'deathsNumAtRisk': 53, 'otherNumAffected': 12, 'seriousNumAtRisk': 53, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'BI 1026706', 'description': 'Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.', 'otherNumAtRisk': 52, 'deathsNumAtRisk': 52, 'otherNumAffected': 14, 'seriousNumAtRisk': 52, 'deathsNumAffected': 0, 'seriousNumAffected': 7}], 'otherEvents': [{'term': 'Visual acuity reduced', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 3}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 6}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Gamma-glutamyltransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 4}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Somnolence', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}], 'seriousEvents': [{'term': 'Myocardial infarction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Localised infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Pneumonia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Aspartate aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Haemoglobin decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Red blood cell count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Generalised tonic-clonic seizure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Glycosuria', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}, {'term': 'Reactive perforating collagenosis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 53, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 52, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': '20.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '47', 'groupId': 'OG000'}, {'value': '47', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI 1026706', 'description': 'Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BI 1026706', 'description': 'Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.'}], 'classes': [{'categories': [{'measurements': [{'value': '-6.19', 'spread': '11.61', 'groupId': 'OG000'}, {'value': '10.26', 'spread': '11.64', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3199', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Adjusted Mean', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '16.45', 'ciLowerLimit': '-16.23', 'ciUpperLimit': '49.13', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '16.45', 'estimateComment': 'Fixed effects of treatment, prior anti-diabetic macular oedema treatment status, visit, treatment by visit interaction, baseline, baseline by visit interaction; patient as a random effect; unstructured covariance matrix for within patient errors.', 'groupDescription': 'Null hypothesis = The CSFT change from baseline at Week 12 is equal in both groups', 'statisticalMethod': 'Mixed model for repeated measurements', 'nonInferiorityType': 'OTHER', 'statisticalComment': 'Kenward-Roger approximation was used for denominator degrees of freedom.'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and Week 12', 'description': 'The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.', 'unitOfMeasure': 'Micrometre [μm]', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set (FAS): FAS includes all patients who were randomised, treated with at least 1 dose of BI 1026706 or placebo, and with a baseline and at least one post randomisation central subfield foveal thickness (CSFT) measurement.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Placebo Matching to BI 1026706', 'description': 'Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.'}, {'id': 'OG001', 'title': 'BI 1026706', 'description': 'Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.'}], 'classes': [{'title': 'Total with SAEs', 'categories': [{'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'Investigator defined drug-related AE', 'categories': [{'measurements': [{'value': '7', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': 'AESIs', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From first drug administration until 4 days after last drug administration, up to 89 days.', 'description': 'Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.', 'unitOfMeasure': 'Count of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Placebo Matching to BI 1026706', 'description': 'Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.'}, {'id': 'FG001', 'title': 'BI 1026706', 'description': 'Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'comment': 'Randomised and treated', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '52'}]}, {'type': 'COMPLETED', 'comment': 'Completed trial', 'achievements': [{'groupId': 'FG000', 'numSubjects': '48'}, {'groupId': 'FG001', 'numSubjects': '46'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '6'}]}], 'dropWithdraws': [{'type': 'Other than listed', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '4'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This was randomised, double-blind, placebo-controlled, parallel-group trial to evaluate pharmacodynamics, safety and tolerability of orally administered Boehringer Ingelheim (BI) 1026706 for 12 weeks in patients with Diabetic Macular Oedema (DME).', 'preAssignmentDetails': 'All patients were screened for eligibility to participate in the trial. Patients attended specialist sites which would then ensure that all patients met all inclusion/exclusion criteria. Patients were not to be randomized to trial treatment if any one of the specific entry criteria were violated.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '53', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '105', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Placebo Matching to BI 1026706', 'description': 'Patients were administered film-coated tablet of placebo to match 100 mg BI 1026706 twice daily orally for 12 weeks.'}, {'id': 'BG001', 'title': 'BI 1026706', 'description': 'Patients were administered film-coated tablet of 100 mg BI 1026706 twice daily orally for 12 weeks.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '62.2', 'spread': '9.7', 'groupId': 'BG000'}, {'value': '63.9', 'spread': '8.7', 'groupId': 'BG001'}, {'value': '63.0', 'spread': '9.2', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'TS'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '39', 'groupId': 'BG000'}, {'value': '38', 'groupId': 'BG001'}, {'value': '77', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}, {'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'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '85', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '14', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'TS'}], 'populationDescription': 'Treated set (TS): TS includes all patients who were treated with at least 1 dose of trial drug, either BI 1026706 or placebo.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-07-26', 'size': 213612, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_000.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2018-09-27T05:15', 'hasProtocol': False}, {'date': '2016-03-07', 'size': 610225, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_001.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2018-09-27T05:15', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-03', 'completionDateStruct': {'date': '2017-10-24', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-03-18', 'studyFirstSubmitDate': '2016-04-05', 'resultsFirstSubmitDate': '2018-10-04', 'studyFirstSubmitQcDate': '2016-04-05', 'lastUpdatePostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-03-18', 'studyFirstPostDateStruct': {'date': '2016-04-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-23', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Central Subfield Foveal Thickness (CSFT) at Week 12', 'timeFrame': 'Baseline and Week 12', 'description': 'The change from baseline in CSFT at Week 12 and the BI 1026706 effect was compared between the BI 1026706 treatment group and the placebo group as measured by Spectral-domain Optical Coherence Tomography (SD-OCT). Baseline was defined as the CSFT value measured at the visit when patients were randomised. Mean presented here is an adjusted mean.'}], 'secondaryOutcomes': [{'measure': 'Number of Subjects With Serious Adverse Events (SAEs), Investigator Defined Drug-related Adverse Events (AEs) and Adverse Events of Special Interest (AESIs)', 'timeFrame': 'From first drug administration until 4 days after last drug administration, up to 89 days.', 'description': 'Number of subjects with serious adverse events (SAEs), Investigator defined drug-related Adverse events (AEs) and adverse events of special interest (AESIs) comparing the BI 1026706 treatment group with the placebo group is presented.'}]}, 'conditionsModule': {'conditions': ['Macular Edema']}, 'descriptionModule': {'briefSummary': 'This is a proof of mechanism trial to explore the effect of BI 1026706 on the central retinal thickness and to evaluate safety and tolerability of BI 1026706 administered orally for 12 weeks in patients with mild vision impairment due to center-involved DME'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients 18 years of age and older\n* Male patients or female patients of non-childbearing potential\n* Diagnosis of Diabetes mellitus type 1 or type 2\n* Retinal thickening due to Diabetic macular edema (DME) involving the center of the macula in the study eye as confirmed by the Investigator on clinical exam\n* Center-involved DME confirmed on Spectral-Domain Optical Coherence Tomography (SD-OCT) with central subfield thickness (CSFT) of at least 300 µm in the study eye at screening, confirmed by Central Reading Centre\n* Best corrected visual acuity ETDRS (Early Treatment Diabetic Retinopathy Study) letter score in the study eye of 84 or below, but at least 70 at screening\n* Further inclusion criteria apply\n\nExclusion criteria:\n\n* Macular edema considered to be due to other causes than DME in the study eye\n* Additional eye disease in the study eye that, in the opinion of the Investigator, might affect macular edema or could compromise or alter visual acuity during the course of the trial\n* Anterior segment and vitreous abnormalities in the study eye that would compromise the adequate assessment of the best corrected visual acuity or an adequate examination of the posterior pole\n* Intraocular surgery in the study eye within 4 months prior to randomization or planned intraocular surgery, including cataract, during the study period\n* Proliferative diabetic retinopathy or iris neovascularisation in the study eye\n* Aphakia in the study eye\n* Any indication that requires immediate treatment or for which treatment is expected in the study eye with anti-Vascular Endothelial Growth Factor (VEGF) or with laser photocoagulation during the period, as per Investigator's judgment\n* History of prior laser photocoagulation or other surgical, intravitreal or peribulbar treatment in the study eye within 4 months prior to randomization, either for DME or an ocular condition other than DME\n* History of fluocinolone acetonide intravitreal implant in the study eye\n* Application of intraocular corticosteroids in the study eye within 2 years prior to randomization in phakic eyes or 9 months in pseudophakic eyes\n* History of topical steroid or nonsteroidal anti-inflammatory drugs (NSAID) treatment in the study eye within 30 days prior to randomization\n* Systemic anti-VEGF or pro-VEGF treatment within 4 months prior to randomization\n* Initiation of intensive insulin treatment (multiple daily injections or a pump) within 3 months prior to randomization or plans to do so in the next 4 months\n* Change in oral antidiabetic medication within 3 months prior to randomization\n* Patients with a clinically relevant abnormal screening haematology, blood chemistry, or urinalysis\n* Renal impairment with estimated creatinine clearance \\< 30 mL/min (as calculated by Cockcroft-Gault equation)\n* Myocardial infarction or unstable angina pectoris within 3 months before randomization\n* Uncontrolled arterial hypertension defined as a single measurement of systolic \\>180 mmHg, two consecutive measurements of systolic \\>160 mmHg, or diastolic \\>100mmHg on optimal medical regimen\n* Further exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT02732951', 'briefTitle': 'Safety and Effect on Central Retinal Thickness of BI 1026706 in Patients With Diabetic Macular Edema', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'A Randomized, Double-masked, Placebo-controlled Exploratory Study to Evaluate Pharmacodynamics, Safety and Tolerability of Orally Administered BI 1026706 for 12 Weeks in Patients With Mild Visual Impairment Due to Center-involved Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': '1320.22'}, 'secondaryIdInfos': [{'id': '2015-003529-33', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BI 1026706', 'interventionNames': ['Drug: BI 1026706']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Placebo', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'BI 1026706', 'type': 'DRUG', 'armGroupLabels': ['BI 1026706']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1020', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Brussels-UNIV Brugmann -Horta', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': '3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'Leuven - UNIV UZ Leuven (Sint-Rafaël)', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '13915', 'city': 'Marseille', 'country': 'France', 'facility': 'HOP Nord', 'geoPoint': {'lat': 43.29695, 'lon': 5.38107}}, {'zip': '44093', 'city': 'Nantes', 'country': 'France', 'facility': 'HOP Hôtel-Dieu', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '75010', 'city': 'Paris', 'country': 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