Vascular disrupting agent for neovascular age related macular degeneration a pilot study of the safety and efficacy of intravenous combretastatin a-4 phosphate 英文参考文献.docVIP

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Vascular disrupting agent for neovascular age related macular degeneration a pilot study of the safety and efficacy of intravenous combretastatin a-4 phosphate 英文参考文献.doc

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Vascular disrupting agent for neovascular age related macular degeneration a pilot study of the safety and efficacy of intravenous combretastatin a-4 phosphate 英文参考文献

Ibrahimetal.BMCPharmacologyandToxicology2013,14:7 /bmcpharmacoltoxicol/2050-6511/14/1/7 RESEARCH ARTICLE OpenAccess Vasculardisruptingagentforneovascularage relatedmaculardegeneration:apilotstudyofthe safetyandefficacyofintravenouscombretastatin a-4phosphate MohamedAIbrahim1,DianaVDo1,6,YasirJSepah1,SyedMShah1,ElizabethVanAnden1,GulnarHafiz1, JKevinDonahue2,3,RichardRivers4,JaiBalkissoon5,JamesTHanda1,PeterACampochiaro1 andQuanDongNguyen1,6* Abstract Background:Thisstudywasdesignedtoassessthesafety,tolerability,andefficacyofintravenousinfusionofCA4P inpatientswithneovascularage-relatedmaculardegeneration(AMD). Methods:Prospective,interventional,dose-escalationclinicaltrial.EightpatientswithneovascularAMDrefractoryto atleast2sessionsofphotodynamictherapyreceivedCA4Patadoseof27or36mg/m2asweeklyintravenous infusionfor4consecutiveweeks.Safetywasmonitoredbyvitalsigns,ocularandphysicalexaminations, electrocardiogram,routinelaboratorytests,andcollectionofadverseevents.Efficacywasassessedusingretinal fluoresceinangiography,opticalcoherencetomography,andbestcorrectedvisualacuity(BCVA). Results:Themostcommonadverseeventswereelevatedbloodpressure(46.7%),QTcprolongation(23.3%), elevatedtemperature(13.3%),andheadache(10%),followedbynauseaandeyeinjection(6.7%).Therewereno adverseeventsthatwereconsideredsevereinintensityandnoneresultedindiscontinuationoftreatment.There wasreductionoftheexcessfovealthicknessby24.15%atendoftreatmentperiodandby43.75%atendofthe two-monthfollow-up(p=0.674and0.161,respectively).BCVAremainedstablethroughoutthetreatmentand follow-upperiods. Conclusions:ThesafetyprofileofintravenousCA4PwasconsistentwiththatreportedinoncologytrialsofCA4P andwiththeclasseffectsofvasculardisruptiveagents;however,thefrequencyofadverseeventswasdifferent. ThereareevidencestosuggestpotentialefficacyofCA4PinneovascularAMD.However,thelevelofsystemic safetyandefficacyindicatesthatsystemicCA4Pmaynotbesuitableasanalternativemonotherapytocurrent standard-of-caretherapy. Trialregistr