Ignite Creation Date:
2025-12-24 @ 7:02 PM
Ignite Modification Date:
2026-01-01 @ 9:35 AM
Study NCT ID:
NCT01571557
Status:
COMPLETED
Last Update Posted:
2019-04-19
First Post:
2012-04-03
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003907', 'term': 'Dexamethasone'}, {'id': 'D002123', 'term': 'Calcium Dobesilate'}], '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': 'Vice President Medical Affairs,', '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 a period that is less than or equal to 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': {'timeFrame': 'Adverse events (AEs) and serious adverse events (SAEs) were collected from the time of the first OZURDEX® injection through the final follow-up visit for each patient.', 'description': 'All enrolled patients were used to assess AEs and SAEs.', 'eventGroups': [{'id': 'EG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.', 'otherNumAtRisk': 573, 'otherNumAffected': 33, 'seriousNumAtRisk': 573, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Intraocular Pressure Increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numAffected': 33}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}], 'seriousEvents': [{'term': 'Glaucoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 573, 'numAffected': 1}], 'organSystem': 'Eye disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA version 16.1'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '351', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '52.431', 'spread': '18.929', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 12', 'categories': [{'measurements': [{'value': '7.774', 'spread': '14.986', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 12', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.', 'unitOfMeasure': 'Approximate EDTRS Letters', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with complete data at this time point'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '46.60', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 48 Weeks', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye', 'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'classes': [{'categories': [{'measurements': [{'value': '36.47', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline, 48 Weeks', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients'}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline in Central Retinal Thickness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '343', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '501.18', 'spread': '169.30', 'groupId': 'OG000'}]}]}, {'title': 'Change from Baseline at Week 24 (N=138)', 'categories': [{'measurements': [{'value': '-61.75', 'spread': '192.28', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Week 24', 'description': 'Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.', 'unitOfMeasure': 'micrometers (μm)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All enrolled patients with complete data at this time point'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '573'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '573'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '573', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'categories': [{'title': '31 to 40 years', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': '41 to 50 years', 'measurements': [{'value': '13', 'groupId': 'BG000'}]}, {'title': '51 to 60 years', 'measurements': [{'value': '69', 'groupId': 'BG000'}]}, {'title': '61 to 70 years', 'measurements': [{'value': '127', 'groupId': 'BG000'}]}, {'title': '71 to 80 years', 'measurements': [{'value': '235', 'groupId': 'BG000'}]}, {'title': '81 to 90 years', 'measurements': [{'value': '119', 'groupId': 'BG000'}]}, {'title': '91 to 100 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '286', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '287', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 573}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2014-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-09', 'studyFirstSubmitDate': '2012-04-03', 'resultsFirstSubmitDate': '2015-06-22', 'studyFirstSubmitQcDate': '2012-04-03', 'lastUpdatePostDateStruct': {'date': '2019-04-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2015-06-22', 'studyFirstPostDateStruct': {'date': '2012-04-05', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2015-07-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye', 'timeFrame': 'Baseline, Week 12', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate Early Treatment Diabetic Retinopathy Study (ETDRS) letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). The higher the number of letters read correctly (higher number on the decimal scale), the better the vision (or visual acuity). A positive number change from baseline in the number of letters read means vision has improved and a negative number change from baseline means vision has worsened.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Patients With an Increase of ≥2 Lines From Baseline BCVA in the Study Eye', 'timeFrame': 'Baseline, 48 Weeks', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 2 letters or more indicates an improvement in BCVA.'}, {'measure': 'Percentage of Patients With an Increase of ≥3 Lines From Baseline BCVA in the Study Eye', 'timeFrame': 'Baseline, 48 Weeks', 'description': 'BCVA is measured in the study eye following each injection of OZURDEX® using the Snellen eye chart. BCVA measurements expressed in Snellen fractions are converted to logMAR units and the approximate ETDRS letter score is based on the formula: approximate ETDRS letters=85+50 x log10 (Snellen fraction). The converted scores are "approximate ETDRS letters" to distinguish the scores from visual acuity measurements obtained using the ETDRS chart. One line on the EDTRS equals 5 ETDRS points. The lower the number of letters read correctly on the eye chart (lower number on the decimal scale) the worse the vision (or visual acuity). An increase of 3 letters or more indicates an improvement in BCVA.'}, {'measure': 'Mean Change From Baseline in Central Retinal Thickness', 'timeFrame': 'Baseline, Week 24', 'description': 'Retinal thickness is assessed by optical coherence tomography (OCT) in the study eye. The retina is the light-sensitive part of the eye. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. A negative mean change from baseline indicates an improvement and a positive mean change from baseline indicates a worsening.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'references': [{'pmid': '25503473', 'type': 'BACKGROUND', 'citation': 'Augustin AJ, Holz FG, Haritoglou C, Mayer WJ, Bopp S, Scheuerle AF, Maier M, Sekundo W, Sandner D, Shirlaw A, Hattenbach LO. Retrospective, observational study in patients receiving a dexamethasone intravitreal implant 0.7 mg for macular oedema secondary to retinal vein occlusion. Ophthalmologica. 2015;233(1):18-26. doi: 10.1159/000368840. Epub 2014 Dec 5.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the relationship between time since onset of macular oedema symptoms and the achievement of vision gain in patients prescribed OZURDEX®. All care and diagnostic procedures provided are at the discretion of the participating physicians according to their clinical judgment and local standard of medical care.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with macular oedema due to retinal vein occlusion', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of macular edema following retinal vein occlusion\n* Prescribed OZURDEX®\n\nExclusion Criteria:\n\n* Previous treatment with OZURDEX®'}, 'identificationModule': {'nctId': 'NCT01571557', 'briefTitle': 'A Safety and Efficacy Study to Assess OZURDEX® in Patients With Macular Oedema Secondary to Retinal Vein Occlusion (RVO)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': 'MAF/AGN/OPH/RET/011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'OZURDEX®', 'description': 'OZURDEX® (dexamethasone 700 ug intravitreal implant) administered according to standard of care.', 'interventionNames': ['Drug: dexamethasone 700 ug intravitreal implant']}], 'interventions': [{'name': 'dexamethasone 700 ug intravitreal implant', 'type': 'DRUG', 'otherNames': ['OZURDEX®'], 'description': 'dexamethasone 700 ug intravitreal implant administered according to standard of care.', 'armGroupLabels': ['OZURDEX®']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Berlin', 'country': 'Germany', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}