{
  "FullStudy":{
    "Rank":218087,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01512901",
          "OrgStudyIdInfo":{
            "OrgStudyId":"01021104"
          },
          "Organization":{
            "OrgFullName":"Santen Pharmaceutical Co., Ltd.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion (HIKARI)",
          "OfficialTitle":"A Randomized, Sham Controlled, Multicenter, Double-Masked, Phase 2/3 Study Assessing Efficacy and Safety of Betamethasone Microsphere in Patients With Macular Edema Following Branch Retinal Vein Occlusion"
        },
        "StatusModule":{
          "StatusVerifiedDate":"July 2014",
          "OverallStatus":"Completed",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StudyFirstSubmitDate":"January 15, 2012",
          "StudyFirstSubmitQCDate":"January 15, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 19, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"July 17, 2014",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"July 21, 2014",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Santen Pharmaceutical Co., Ltd.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{},
        "DescriptionModule":{
          "BriefSummary":"This study will evaluate the efficacy and safety of Betamethasone Microsphere (DE-102) for macular edema following branch retinal vein occlusion"
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Macular Edema Following Branch Retinal Vein Occlusion"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Phase 2",
              "Phase 3"
            ]
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"1",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Betamethasone Microsphere (DE-102） Low Dose"
                  ]
                }
              },{
                "ArmGroupLabel":"2",
                "ArmGroupType":"Experimental",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Betamethasone Microsphere (DE-102） High Dose"
                  ]
                }
              },{
                "ArmGroupLabel":"3",
                "ArmGroupType":"Sham Comparator",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Drug: Sham"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Drug",
                "InterventionName":"Betamethasone Microsphere (DE-102） Low Dose",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "1"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Betamethasone Microsphere (DE-102） High Dose",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "2"
                  ]
                }
              },{
                "InterventionType":"Drug",
                "InterventionName":"Sham",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "3"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Change from baseline of Best Corrected Visual Acuity(BCVA) in ETDRS letter score"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Change in retinal thickness from baseline"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\n20 years of age or older\nDiagnosis of macular edema following branch retinal vein occlusion\n\nExclusion Criteria:\n\nBCVA ETDRS letter score in non-study eye < 35\nKnown steroid-responder",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"20 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Santen study sites",
                "LocationCity":"Osaka",
                "LocationCountry":"Japan"
              },{
                "LocationFacility":"Santen study sites",
                "LocationCity":"Seoul",
                "LocationCountry":"Korea, Republic of"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "InterventionBrowseModule":{
          "InterventionMeshList":{
            "InterventionMesh":[
              {
                "InterventionMeshId":"D000001623",
                "InterventionMeshTerm":"Betamethasone"
              },{
                "InterventionMeshId":"D000001624",
                "InterventionMeshTerm":"Betamethasone Valerate"
              },{
                "InterventionMeshId":"C000011175",
                "InterventionMeshTerm":"Betamethasone-17,21-dipropionate"
              },{
                "InterventionMeshId":"C000015706",
                "InterventionMeshTerm":"Betamethasone benzoate"
              },{
                "InterventionMeshId":"C000028994",
                "InterventionMeshTerm":"Betamethasone sodium phosphate"
              }
            ]
          },
          "InterventionAncestorList":{
            "InterventionAncestor":[
              {
                "InterventionAncestorId":"D000000893",
                "InterventionAncestorTerm":"Anti-Inflammatory Agents"
              },{
                "InterventionAncestorId":"D000005938",
                "InterventionAncestorTerm":"Glucocorticoids"
              },{
                "InterventionAncestorId":"D000006728",
                "InterventionAncestorTerm":"Hormones"
              },{
                "InterventionAncestorId":"D000006730",
                "InterventionAncestorTerm":"Hormones, Hormone Substitutes, and Hormone Antagonists"
              },{
                "InterventionAncestorId":"D000045505",
                "InterventionAncestorTerm":"Physiological Effects of Drugs"
              },{
                "InterventionAncestorId":"D000018927",
                "InterventionAncestorTerm":"Anti-Asthmatic Agents"
              },{
                "InterventionAncestorId":"D000019141",
                "InterventionAncestorTerm":"Respiratory System Agents"
              }
            ]
          },
          "InterventionBrowseLeafList":{
            "InterventionBrowseLeaf":[
              {
                "InterventionBrowseLeafId":"M3490",
                "InterventionBrowseLeafName":"Betamethasone",
                "InterventionBrowseLeafAsFound":"Betamethasone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M3491",
                "InterventionBrowseLeafName":"Betamethasone Valerate",
                "InterventionBrowseLeafAsFound":"Betamethasone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M237044",
                "InterventionBrowseLeafName":"Betamethasone-17,21-dipropionate",
                "InterventionBrowseLeafAsFound":"Betamethasone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M268151",
                "InterventionBrowseLeafName":"Betamethasone benzoate",
                "InterventionBrowseLeafAsFound":"Betamethasone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M257068",
                "InterventionBrowseLeafName":"Betamethasone sodium phosphate",
                "InterventionBrowseLeafAsFound":"Betamethasone",
                "InterventionBrowseLeafRelevance":"high"
              },{
                "InterventionBrowseLeafId":"M2798",
                "InterventionBrowseLeafName":"Anti-Inflammatory Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M7630",
                "InterventionBrowseLeafName":"Glucocorticoids",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8372",
                "InterventionBrowseLeafName":"Hormones",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M8371",
                "InterventionBrowseLeafName":"Hormone Antagonists",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19547",
                "InterventionBrowseLeafName":"Anti-Asthmatic Agents",
                "InterventionBrowseLeafRelevance":"low"
              },{
                "InterventionBrowseLeafId":"M19721",
                "InterventionBrowseLeafName":"Respiratory System Agents",
                "InterventionBrowseLeafRelevance":"low"
              }
            ]
          },
          "InterventionBrowseBranchList":{
            "InterventionBrowseBranch":[
              {
                "InterventionBrowseBranchAbbrev":"Infl",
                "InterventionBrowseBranchName":"Anti-Inflammatory Agents"
              },{
                "InterventionBrowseBranchAbbrev":"Resp",
                "InterventionBrowseBranchName":"Respiratory System Agents"
              },{
                "InterventionBrowseBranchAbbrev":"All",
                "InterventionBrowseBranchName":"All Drugs and Chemicals"
              }
            ]
          }
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008269",
                "ConditionMeshTerm":"Macular Edema"
              },{
                "ConditionMeshId":"D000012170",
                "ConditionMeshTerm":"Retinal Vein Occlusion"
              },{
                "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"
              },{
                "ConditionAncestorId":"D000020246",
                "ConditionAncestorTerm":"Venous Thrombosis"
              },{
                "ConditionAncestorId":"D000013927",
                "ConditionAncestorTerm":"Thrombosis"
              },{
                "ConditionAncestorId":"D000016769",
                "ConditionAncestorTerm":"Embolism and Thrombosis"
              },{
                "ConditionAncestorId":"D000014652",
                "ConditionAncestorTerm":"Vascular Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9844",
                "ConditionBrowseLeafName":"Macular Edema",
                "ConditionBrowseLeafAsFound":"Macular Edema",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M6240",
                "ConditionBrowseLeafName":"Edema",
                "ConditionBrowseLeafAsFound":"Edema",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M13588",
                "ConditionBrowseLeafName":"Retinal Vein Occlusion",
                "ConditionBrowseLeafAsFound":"Retinal Vein Occlusion",
                "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"
              },{
                "ConditionBrowseLeafId":"M15269",
                "ConditionBrowseLeafName":"Thrombosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M20655",
                "ConditionBrowseLeafName":"Venous Thrombosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M6367",
                "ConditionBrowseLeafName":"Embolism",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M17711",
                "ConditionBrowseLeafName":"Embolism and Thrombosis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafRelevance":"low"
              }
            ]
          },
          "ConditionBrowseBranchList":{
            "ConditionBrowseBranch":[
              {
                "ConditionBrowseBranchAbbrev":"BC11",
                "ConditionBrowseBranchName":"Eye Diseases"
              },{
                "ConditionBrowseBranchAbbrev":"All",
                "ConditionBrowseBranchName":"All Conditions"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}