{
  "FullStudy":{
    "Rank":217829,
    "Study":{
      "ProtocolSection":{
        "IdentificationModule":{
          "NCTId":"NCT01516294",
          "OrgStudyIdInfo":{
            "OrgStudyId":"CLH004"
          },
          "Organization":{
            "OrgFullName":"Oraya Therapeutics, Inc.",
            "OrgClass":"INDUSTRY"
          },
          "BriefTitle":"IRay to Treat Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD",
          "OfficialTitle":"A Pilot, Single-center, Interventional Clinical Trial in Which Subjects With Polypoidal Choroidal Vasculopathy (PCV) Secondary to Age-Related Macular Degeneration (AMD) Will Receive Low Voltage Stereotactic Radiotherapy (IRay®) Treatment and Lucentis® Treatment as Needed."
        },
        "StatusModule":{
          "StatusVerifiedDate":"October 2012",
          "OverallStatus":"Unknown status",
          "LastKnownStatus":"Active, not recruiting",
          "ExpandedAccessInfo":{
            "HasExpandedAccess":"No"
          },
          "StartDateStruct":{
            "StartDate":"January 2012"
          },
          "PrimaryCompletionDateStruct":{
            "PrimaryCompletionDate":"March 2013",
            "PrimaryCompletionDateType":"Anticipated"
          },
          "CompletionDateStruct":{
            "CompletionDate":"March 2014",
            "CompletionDateType":"Anticipated"
          },
          "StudyFirstSubmitDate":"January 19, 2012",
          "StudyFirstSubmitQCDate":"January 23, 2012",
          "StudyFirstPostDateStruct":{
            "StudyFirstPostDate":"January 24, 2012",
            "StudyFirstPostDateType":"Estimate"
          },
          "LastUpdateSubmitDate":"October 31, 2012",
          "LastUpdatePostDateStruct":{
            "LastUpdatePostDate":"November 1, 2012",
            "LastUpdatePostDateType":"Estimate"
          }
        },
        "SponsorCollaboratorsModule":{
          "ResponsibleParty":{
            "ResponsiblePartyType":"Sponsor"
          },
          "LeadSponsor":{
            "LeadSponsorName":"Oraya Therapeutics, Inc.",
            "LeadSponsorClass":"INDUSTRY"
          }
        },
        "OversightModule":{
          "OversightHasDMC":"Yes"
        },
        "DescriptionModule":{
          "BriefSummary":"This study will evaluate the efficacy of IRay treatment in patients with Polypoidal Choroidal Vasculopathy (PCV)secondary to AMD as determined by the change in the proportion of lesion activity and lesion size at 12 months.",
          "DetailedDescription":"This is a single-center, interventional clinical trial in which subjects will receive 16 Gy of IRay treatment and Lucentis, followed by Lucentis treatment as needed to evaluate the efficacy of IRay treatment in patients with PCV as determined by the change in the proportion of lesion activity and lesion size at 12 months."
        },
        "ConditionsModule":{
          "ConditionList":{
            "Condition":[
              "Polypoidal Chorodial Vasculopathy",
              "Age Related Macular Degeneration"
            ]
          },
          "KeywordList":{
            "Keyword":[
              "AMD",
              "PCV",
              "Iray",
              "radiation",
              "retina",
              "macula",
              "radiotherapy"
            ]
          }
        },
        "DesignModule":{
          "StudyType":"Interventional",
          "PhaseList":{
            "Phase":[
              "Not Applicable"
            ]
          },
          "DesignInfo":{
            "DesignInterventionModel":"Single Group Assignment",
            "DesignPrimaryPurpose":"Treatment",
            "DesignMaskingInfo":{
              "DesignMasking":"None (Open Label)"
            }
          },
          "EnrollmentInfo":{
            "EnrollmentCount":"12",
            "EnrollmentType":"Anticipated"
          }
        },
        "ArmsInterventionsModule":{
          "ArmGroupList":{
            "ArmGroup":[
              {
                "ArmGroupLabel":"Iray plus Lucentis",
                "ArmGroupType":"Experimental",
                "ArmGroupDescription":"open label arm in which all subjects recieve a single 16 gy dose of radiation plus an injection of Lucentis.",
                "ArmGroupInterventionList":{
                  "ArmGroupInterventionName":[
                    "Radiation: Iray"
                  ]
                }
              }
            ]
          },
          "InterventionList":{
            "Intervention":[
              {
                "InterventionType":"Radiation",
                "InterventionName":"Iray",
                "InterventionDescription":"The Oraya IRay stereotactic radiotherapy device will be used to deliver a 16 Gy dose of radiation to the macula. The radiotherapy will be delivered in a single session utilizing three sequential beams, each depositing 5.3 Gy at the macula through calculated scleral entry points, crossing the pars plana region of the eye, and overlapping at the same region of the macula.",
                "InterventionArmGroupLabelList":{
                  "InterventionArmGroupLabel":[
                    "Iray plus Lucentis"
                  ]
                }
              }
            ]
          }
        },
        "OutcomesModule":{
          "PrimaryOutcomeList":{
            "PrimaryOutcome":[
              {
                "PrimaryOutcomeMeasure":"Lesion change as measured with fluorescein angiography.",
                "PrimaryOutcomeDescription":"Change in the proportion of the lesion which is active at 12 months.",
                "PrimaryOutcomeTimeFrame":"Baseline and 12 months"
              }
            ]
          },
          "SecondaryOutcomeList":{
            "SecondaryOutcome":[
              {
                "SecondaryOutcomeMeasure":"Number of Lucentis injections",
                "SecondaryOutcomeDescription":"Number of Lucentis injections during 12 months",
                "SecondaryOutcomeTimeFrame":"baseline and 12 months"
              },{
                "SecondaryOutcomeMeasure":"Visual Acuity change",
                "SecondaryOutcomeDescription":"Mean change in visual acuity",
                "SecondaryOutcomeTimeFrame":"Baseline and 12 months"
              },{
                "SecondaryOutcomeMeasure":"Polyp changes",
                "SecondaryOutcomeDescription":"Change in total lesion and polyp size & number of polyps",
                "SecondaryOutcomeTimeFrame":"Baseline and 12 months"
              }
            ]
          }
        },
        "EligibilityModule":{
          "EligibilityCriteria":"Inclusion Criteria:\n\nPatients with PCV, naïve or previously treated with Lucentis injections and Photodynamic therapy (PDT) using Visudyne.\nMust have a total lesion size of <12 disc areas and a PCV lesion with the greatest linear dimension of <6 mm, but not greater than 3 mm from the center of the fovea to the furthest point on lesion perimeter (determined by ICG).\nThe distance from the center of the fovea to the nearest edge of the optic disc should be not less than 3 mm. (This distance is confirmed by Oraya software prior to treatment.).\nMust have provided informed consent, documented it in writing, and have been given a copy of the signed informed consent form.\nMust be willing and able to return for scheduled visits for the 2-year duration of the study.\nMust be at least 50 years of age.\nWomen must be post-menopausal ≥1 year or surgically sterilized, or a pregnancy screen must be performed prior to the study and a reliable form of contraception, approved by the investigator, must be maintained during the study.\nMust have best corrected visual acuity of 75 to 25 letters (inclusive) in the study eye and at least 20 letters in the fellow eye (if both eyes meet all the study criteria, then the eye with the worst vision should be selected as the study eye).\n\nExclusion Criteria:\n\nCNV due to causes other than AMD or PCV, including ocular histoplasmosis syndrome, angioid streaks, multifocal choroiditis, choroidal rupture, or pathologic myopia (spherical equivalent -8 diopters).\nA globe axial length of <20 mm or >26 mm.\nEvidence of diabetes or with retinal findings consistent with diabetic retinopathy or retinopathy for any other cause.\nHypertension that is not controlled with anti-hypertensive medication.\nPrior or concurrent therapies for age related macular degeneration or PCV, including submacular surgery, subfoveal thermal laser photocoagulation (with or without photographic evidence), or transpupillary thermotherapy (TTT).\nHistory of radiation to the head in the region of the study eye.\nPrevious posterior vitrectomy at any time, YAG capsulotomy or cataract surgery within 3 months, or any other surgery in the study eye within 6 months prior to the screening visit.\nIntravitreal device in the study eye.\nConcomitant disease in the study eye which might interfere with the effect of assessment of the study treatment, including uveitis, acute ocular or periocular infection, retinal vasculopathies (including retinal vein occlusions, etc.) or intraocular pressure >30 mmHg uncontrollable with medications.\nHistory of rhegmatogenous retina detachment, optic neuritis or intraocular tumors in the study eye.\nInadequate pupillary dilation, significant media opacities, or other conditions in the study eye, including cataract, which may interfere with visual acuity or the evaluation of the posterior segment. Subjects likely to need cataract surgery during the 1 year study period should also not be enrolled.\nKnown serious allergies to fluorescein or indocyanine green dye used in angiography.\nSubjects must not have subretinal hemorrhage or Retinal Pigment Epithelium tear involving the center of the foveal avascular zone.\nKnown sensitivity or allergy to Lucentis, or any other drug used in the study, such as topical anesthetic, cycloplegic mydriatics, or lubricating eye gel.\nContraindication or sensitivity to contact lens application (i.e. corneal dystrophies and recurrent corneal erosions). 16. Currently receiving chemotherapy, having completed a course within the 90 days preceding study enrollment, or expecting to begin chemotherapy while participating in the study.\nCurrent participation in another PCV drug or device clinical trial.\nHistory of use of drugs with known retinal toxicity, including: chloroquine (Aralen - antimalarial), hydroxychloriquine (Plaquenil - antimalarial), phenothiazines (Thorazine, Stelazine, Mellaril, Prolixin, Trilafon, etc., - tranquilizing antipsychotic medications) and these patients are exhibiting signs of retinal toxicity.\nConcurrent use of systemic anti-VEGF agents.\nAny other condition, which in the judgment of the investigator would prevent the subject from granting consent or completing the study, such as dementia, mental illness (including generalized anxiety disorder, claustrophobia, etc.), or inability to position in the device (due to musculoskeletal problems, etc.).\nHistory of other significant, uncontrolled disease including cardiovascular, nervous system, pulmonary, renal, hepatic, endocrine or gastrointestinal, metabolic dysfunction, any clinical finding giving reasonable suspicion of a disease or condition that contraindicates the use of intravitreal ranibizumab or that might affect interpretation of the results of the study or render the subject at high risk for treatment complication",
          "HealthyVolunteers":"No",
          "Gender":"All",
          "MinimumAge":"50 Years",
          "StdAgeList":{
            "StdAge":[
              "Adult",
              "Older Adult"
            ]
          }
        },
        "ContactsLocationsModule":{
          "LocationList":{
            "Location":[
              {
                "LocationFacility":"Università Vita-Salute Istituto Scientifico San Raffaele",
                "LocationCity":"Milano",
                "LocationCountry":"Italy"
              }
            ]
          }
        }
      },
      "DerivedSection":{
        "MiscInfoModule":{
          "VersionHolder":"April 22, 2020"
        },
        "ConditionBrowseModule":{
          "ConditionMeshList":{
            "ConditionMesh":[
              {
                "ConditionMeshId":"D000008268",
                "ConditionMeshTerm":"Macular Degeneration"
              },{
                "ConditionMeshId":"D000014652",
                "ConditionMeshTerm":"Vascular Diseases"
              }
            ]
          },
          "ConditionAncestorList":{
            "ConditionAncestor":[
              {
                "ConditionAncestorId":"D000012162",
                "ConditionAncestorTerm":"Retinal Degeneration"
              },{
                "ConditionAncestorId":"D000012164",
                "ConditionAncestorTerm":"Retinal Diseases"
              },{
                "ConditionAncestorId":"D000005128",
                "ConditionAncestorTerm":"Eye Diseases"
              },{
                "ConditionAncestorId":"D000002318",
                "ConditionAncestorTerm":"Cardiovascular Diseases"
              }
            ]
          },
          "ConditionBrowseLeafList":{
            "ConditionBrowseLeaf":[
              {
                "ConditionBrowseLeafId":"M9843",
                "ConditionBrowseLeafName":"Macular Degeneration",
                "ConditionBrowseLeafAsFound":"Macular Degeneration",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "ConditionBrowseLeafId":"M10890",
                "ConditionBrowseLeafName":"Neoplasm Metastasis",
                "ConditionBrowseLeafRelevance":"low"
              },{
                "ConditionBrowseLeafId":"M15983",
                "ConditionBrowseLeafName":"Vascular Diseases",
                "ConditionBrowseLeafAsFound":"Vasculopathy",
                "ConditionBrowseLeafRelevance":"high"
              },{
                "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":"BC04",
                "ConditionBrowseBranchName":"Cancers and Other Neoplasms"
              },{
                "ConditionBrowseBranchAbbrev":"BC23",
                "ConditionBrowseBranchName":"Symptoms and General Pathology"
              },{
                "ConditionBrowseBranchAbbrev":"BC14",
                "ConditionBrowseBranchName":"Heart and Blood Diseases"
              }
            ]
          }
        }
      }
    }
  }
}