Ignite Creation Date:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-26 @ 2:40 AM
Study NCT ID:
NCT01660802
Status:
COMPLETED
Last Update Posted:
2019-04-17
First Post:
2012-08-07
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'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'}, {'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head,', 'organization': 'Allergan, Inc'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for at least 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'description': 'The Safety Population included all treated patients and was used to assess adverse events (AEs) and serious adverse events (SAEs). Treatment emergent adverse events (TEAE) are reported and include all AEs and SAEs that began or worsened after study treatment.', 'eventGroups': [{'id': 'EG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.', 'otherNumAtRisk': 129, 'otherNumAffected': 69, 'seriousNumAtRisk': 129, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.', 'otherNumAtRisk': 130, 'otherNumAffected': 15, 'seriousNumAtRisk': 130, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Conjunctival Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Conjunctival Hyperaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 17}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 6}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Intraocular Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 38}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'seriousEvents': [{'term': 'Atrioventricular Block', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 0}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Cholecystitis Chronic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Hepatobiliary disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}, {'term': 'Vitreous Haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 129, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 130, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 17.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '60', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 6 Months', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.', 'unitOfMeasure': 'Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Average Change From Baseline in BCVA in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.6', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Average Change from Baseline Over 6 Months', 'categories': [{'measurements': [{'value': '6.6', 'spread': '8.98', 'groupId': 'OG000'}, {'value': '2.5', 'spread': '9.98', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, 6 Months', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.', 'unitOfMeasure': 'Letters Read Correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in BCVA in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.6', 'spread': '10.79', 'groupId': 'OG000'}, {'value': '53.1', 'spread': '10.47', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 1', 'categories': [{'measurements': [{'value': '9.1', 'spread': '8.45', 'groupId': 'OG000'}, {'value': '2.0', 'spread': '9.28', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 2', 'categories': [{'measurements': [{'value': '10.6', 'spread': '10.36', 'groupId': 'OG000'}, {'value': '1.7', 'spread': '12.29', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 3', 'categories': [{'measurements': [{'value': '7.7', 'spread': '12.66', 'groupId': 'OG000'}, {'value': '1.8', 'spread': '12.98', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 4', 'categories': [{'measurements': [{'value': '5.2', 'spread': '12.79', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '12.32', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 5', 'categories': [{'measurements': [{'value': '4.4', 'spread': '13.28', 'groupId': 'OG000'}, {'value': '3.3', 'spread': '13.04', 'groupId': 'OG001'}]}]}, {'title': 'Change from Baseline at Month 6', 'categories': [{'measurements': [{'value': '3.2', 'spread': '15.34', 'groupId': 'OG000'}, {'value': '4.0', 'spread': '13.73', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.', 'unitOfMeasure': 'Letters Read Correctly', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all randomized and treated patients'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '129', 'groupId': 'OG000'}, {'value': '130', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'OG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}], 'classes': [{'title': 'Month 1', 'categories': [{'measurements': [{'value': '28.7', 'groupId': 'OG000'}, {'value': '5.4', 'groupId': 'OG001'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '34.9', 'groupId': 'OG000'}, {'value': '11.5', 'groupId': 'OG001'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '33.3', 'groupId': 'OG000'}, {'value': '13.1', 'groupId': 'OG001'}]}]}, {'title': 'Month 4', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '14.6', 'groupId': 'OG001'}]}]}, {'title': 'Month 5', 'categories': [{'measurements': [{'value': '22.5', 'groupId': 'OG000'}, {'value': '22.3', 'groupId': 'OG001'}]}]}, {'title': 'Month 6', 'categories': [{'measurements': [{'value': '23.3', 'groupId': 'OG000'}, {'value': '20.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Modified Intent-to-Treat: all randomized and treated patients'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'FG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '130'}, {'groupId': 'FG001', 'numSubjects': '132'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '126'}, {'groupId': 'FG001', 'numSubjects': '121'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'BG000'}, {'value': '132', 'groupId': 'BG001'}, {'value': '262', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.'}, {'id': 'BG001', 'title': 'Sham', 'description': 'Sham administered in the study eye on Day 1.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': '<45 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}, {'title': '45 to 65 years', 'categories': [{'measurements': [{'value': '94', 'groupId': 'BG000'}, {'value': '86', 'groupId': 'BG001'}, {'value': '180', 'groupId': 'BG002'}]}]}, {'title': '> 65 years', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '39', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '76', 'groupId': 'BG001'}, {'value': '136', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '70', 'groupId': 'BG000'}, {'value': '56', 'groupId': 'BG001'}, {'value': '126', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 262}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-05-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2012-08-07', 'resultsFirstSubmitDate': '2015-04-02', 'studyFirstSubmitQcDate': '2012-08-07', 'lastUpdatePostDateStruct': {'date': '2019-04-17', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-05-22', 'studyFirstPostDateStruct': {'date': '2012-08-09', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-06-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Patients With 15 or More Letter Improvement in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'timeFrame': 'Baseline, 6 Months', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. The numbers of patients with at least a 15 or more letter improvement in BCVA in the study eye are presented.'}], 'secondaryOutcomes': [{'measure': 'Average Change From Baseline in BCVA in the Study Eye', 'timeFrame': 'Baseline, 6 Months', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The average BCVA is calculated across study visits for each patient. A positive number change from baseline indicates an improvement and a negative number change from baseline indicates a worsening.'}, {'measure': 'Change From Baseline in BCVA in the Study Eye', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved. A decrease in the number of letters read correctly (negative number) means that vision has worsened.'}, {'measure': 'Percentage of Patients With BCVA Improvement of ≥15 Letters From Baseline in the Study Eye', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3, Month 4, Month 5, Month 6', 'description': 'BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters) in the study eye. The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly indicates improvement and a decrease in the number of letters read correctly indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Edema']}, 'referencesModule': {'references': [{'pmid': '29119239', 'type': 'BACKGROUND', 'citation': 'Li X, Wang N, Liang X, Xu G, Li XY, Jiao J, Lou J, Hashad Y; China Ozurdex in RVO Study Group. Safety and efficacy of dexamethasone intravitreal implant for treatment of macular edema secondary to retinal vein occlusion in Chinese patients: randomized, sham-controlled, multicenter study. Graefes Arch Clin Exp Ophthalmol. 2018 Jan;256(1):59-69. doi: 10.1007/s00417-017-3831-6. Epub 2017 Nov 8.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess the safety and efficacy of 700 μg dexamethasone Posterior Segment Drug Delivery System (DEX PS DDS) Applicator System in patients with macular edema in a 6 month double-blind period versus sham followed by a 2 month open label period.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n-Presence of macular edema defined as macular thickening involving the center of the macula due to branch retinal vein occlusion (BRVO) or central retinal vein occlusion (CRVO)\n\nExclusion Criteria:\n\n* History of glaucoma, ocular hypertension or optic nerve head change\n* Any active bacterial, viral, parasitic, or fungal infections in either eye\n* Eye surgery, including cataract surgery, and/or laser of any type in the study eye within 3 months prior to study start\n* History of use of intravitreal steroids or any intravitreal injectable drug in the study eye within 3 months prior to study start\n* Use of oral, intravenous, intramuscular, epidural, rectal, or extensive dermal steroids within 1 month prior to study start\n* Use of immunosuppressants, immunomodulators, antimetabolites, and/or alkylating agents within 3 months prior to study start\n* Use of topical ophthalmic corticosticosteroids within 2 weeks of study start'}, 'identificationModule': {'nctId': 'NCT01660802', 'briefTitle': 'Safety and Efficacy Study of Dexamethasone in the Treatment of Patients With Macular Edema Following Retinal Vein Occlusion (RVO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '206207-020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '700 μg Dexamethasone', 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.', 'interventionNames': ['Drug: 700 μg Dexamethasone']}, {'type': 'SHAM_COMPARATOR', 'label': 'Sham', 'description': 'Sham administered in the study eye on Day 1.', 'interventionNames': ['Drug: 700 μg Dexamethasone', 'Other: Sham']}], 'interventions': [{'name': '700 μg Dexamethasone', 'type': 'DRUG', 'otherNames': ['Ozurdex®'], 'description': '700 μg Dexamethasone intravitreal injection in the study eye on Day 1.', 'armGroupLabels': ['700 μg Dexamethasone', 'Sham']}, {'name': 'Sham', 'type': 'OTHER', 'description': 'Sham administered in the study eye on Day 1.', 'armGroupLabels': ['Sham']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'country': 'China', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}