{
  "FullStudy":{
    "Rank":218082,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512966",
          "OrgStudyIdInfo":{
            "OrgStudyId":"15657"
          },
          "Organization":{
            "OrgFullName":"Bayer",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Japanese Safety Study of VEGF Trap-Eye in DME (Diabetic Macular Edema)",
          "OfficialTitle":"An Open-label Phase III Study Evaluating the Safety and Tolerability of Repeated Doses of Intravitreal VEGF Trap-Eye in Japanese Subjects With Diabetic Macular Edema",
          "Acronym":"VIVID-Japan"
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"September 2013",
            "PrimaryCompletionDateType":"Actual"
          },
          "CompletionDateStruct":{
            "CompletionDate":"September 2013",
            "CompletionDateType":"Actual"
          },
          "StudyFirstSubmitDate":"January 16, 2012",
          "StudyFirstSubmitQCDate":"January 16, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 20, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 8, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"October 9, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Bayer",
            "LeadSponsorClass":"INDUSTRY"
          },
          "CollaboratorList":{
            "Collaborator":[
              {
                "CollaboratorName":"Regeneron Pharmaceuticals",
                "CollaboratorClass":"INDUSTRY"
              }
            ]
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This study will assess the safety and tolerability of intravitreally (IVT) administered VEGF Trap-Eye in Japanese subjects with diabetic macular edema (DME) over the period of one year."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Macular Edema"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "Diabetic Macular Edema",
              "DME",
              "VEGF Trap-Eye",
              "best-corrected visual acuity (BCVA)"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 3"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"73",
            "EnrollmentType":"Actual"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"VTE 2Q4 first, then VTE 2Q8",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"VEGF Trap-Eye [BAY86-5321; EYLEA (aflibercept) Injection] 2 mg Q4 (VTE 2Q4) administered every 4 weeks from Week 0 to Week 16, followed by every 8 weeks until Week 48 (2Q8)",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Biological: VEGF Trap-Eye (BAY86-5321)"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Biological",
                "InterventionName":"VEGF Trap-Eye (BAY86-5321)",
                "InterventionDescription":"Subjects in the VEGF Trap-Eye group will receive intravitreal injections every 8 weeks following a loading phase with injections given every 4 weeks. The overall treatment period is 48 weeks.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "VTE 2Q4 first, then VTE 2Q8"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Adverse Event collection",
                "PrimaryOutcomeTimeFrame":"Week 52"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change from baseline in BCVA (best corrected visual acuity) letter score",
                "SecondaryOutcomeTimeFrame":"Week 52"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nAdults ≥ 18 years with type 1 or 2 diabetes mellitus\nSubjects with DME (diabetic macular edema) secondary to diabetes mellitus involving the center of the macula in the study eye\nBCVA (best-corrected visual acuity) ETDRS (Early Treatment Diabetic Retinopathy Study) letter score of 73 to 24 (20/40 to 20/320) in the study eye\n\nExclusion Criteria:\n\nActive proliferative diabetic retinopathy (PDR) in the study eye\nUncontrolled diabetes mellitus, as defined by HbA1c >12%\nOnly 1 functional eye even if that eye is otherwise eligible for the study",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"18 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "OverallOfficialList":{
            "OverallOfficial":[
              {
                "OverallOfficialName":"Bayer Study Director",
                "OverallOfficialAffiliation":"Bayer",
                "OverallOfficialRole":"Study Director"
              }
            ]
          },
          "LocationList":{
            "Location":[
              {
                "LocationCity":"Matsuyama",
                "LocationState":"Ehime",
                "LocationZip":"790-8524",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Maebashi",
                "LocationState":"Gunma",
                "LocationZip":"371-8511",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kobe",
                "LocationState":"Hyogo",
                "LocationZip":"650-0017",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Mito",
                "LocationState":"Ibaraki",
                "LocationZip":"310-0015",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kita",
                "LocationState":"Kagawa",
                "LocationZip":"761-0793",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kawasaki",
                "LocationState":"Kanagawa",
                "LocationZip":"216-8511",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Sendai",
                "LocationState":"Miyagi",
                "LocationZip":"984-8560",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kashihara",
                "LocationState":"Nara",
                "LocationZip":"634-8522",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Suita",
                "LocationState":"Osaka",
                "LocationZip":"565-0871",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Otsu",
                "LocationState":"Shiga",
                "LocationZip":"520-2192",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Shimotsuke",
                "LocationState":"Tochigi",
                "LocationZip":"329-0498",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kagoshima",
                "LocationZip":"890-8520",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Kyoto",
                "LocationZip":"606-8507",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Okayama",
                "LocationZip":"700-8558",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Osaka",
                "LocationZip":"537-0025",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Osaka",
                "LocationZip":"558-8558",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Saga",
                "LocationZip":"840-8571",
                "LocationCountry":"Japan"
              },{
                "LocationCity":"Wakayama",
                "LocationZip":"641-8510",
                "LocationCountry":"Japan"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008269",
                "ConditionMeshTerm":"Macular Edema"
              },{
                "ConditionMeshId":"D000004487",
                "ConditionMeshTerm":"Edema"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012816",
                "ConditionAncestorTerm":"Signs and Symptoms"
              },{
                "ConditionAncestorId":"D000008268",
                "ConditionAncestorTerm":"Macular Degeneration"
              },{
                "ConditionAncestorId":"D000012162",
                "ConditionAncestorTerm":"Retinal Degeneration"
              },{
                "ConditionAncestorId":"D000012164",
                "ConditionAncestorTerm":"Retinal Diseases"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9844",
                "ConditionBrowseLeafName":"Macular Edema",
                "ConditionBrowseLeafAsFound":"Macular Edema",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6240",
                "ConditionBrowseLeafName":"Edema",
                "ConditionBrowseLeafAsFound":"Edema",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M9843",
                "ConditionBrowseLeafName":"Macular Degeneration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13580",
                "ConditionBrowseLeafName":"Retinal Degeneration",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M13582",
                "ConditionBrowseLeafName":"Retinal Diseases",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6854",
                "ConditionBrowseLeafName":"Eye Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              }
            ]
          }
        }
      }
    }
  }
}