Subconjunctival Sirolimus in the Treatment of AMD Bilateral Geographic Atrophy
Subconjunctival Sirolimus in the Treatment of AMD Bilateral Geographic Atrophy
批准号:
8075880
负责人:
DARBY THOMPSON
金额:
$13.56万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2006
资助国家:
美国
项目状态:
已结题
起止时间:
2006-11-01 至 2011-10-31
关键词:
Acquired Immunodeficiency SyndromeAffectAge related macular degenerationAntibioticsArea AnalysesBilateralBloodBlood Chemical AnalysisBlood TestsCase-Control StudiesCellsChinClinic VisitsClinical ResearchClinical TrialsCollectionContractorContractsDataDatabasesDiabetic RetinopathyDropsEarly treatmentEconomicsEpidemiologyEvaluationExtramural ActivitiesEyeEye MovementsEye diseasesEyedropsHeadHealthcareImageInflammationInjection of therapeutic agentIntramural ResearchLightLiverLocal Anti-Infective AgentsMeasurementMeasuresMedicareMonitorNatural HistoryOphthalmic examination and evaluationOptical Coherence TomographyOutcomes ResearchParticipantPatientsPharmaceutical PreparationsPilot ProjectsPregnancy TestsProceduresPupilQuality-of-Life AssessmentRenal functionResearch DesignRestRetinaScanningSirolimusSpecific qualifier valueTestingThickUrineUveitisVisionVision DisordersVisitVisual AcuityWomanWorkcost effectivenessdata managementdesignfollow-upgeographic atrophymaculapatient safetypreclinical studypregnantpressureprevent
中文摘要
结膜下西罗莫司治疗老年性黄斑变性(AMD)伴双侧地理萎缩的初步研究
英文摘要
Pilot Study of the Evaluation of Subconjunctival Sirolimus in the Treatment of Bilateral Geographic Atrophy Associated with Age-Related Macular Degeneration (AMD)
Clinical Protocol support contract designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases.
Objective of Clinical Protocol:
This study will determine if a drug called sirolimus is safe to give to people with geographic atrophy GA and if it can help preserve vision in patients. GA is an advanced form of dry age-related macular degeneration (AMD). AMD affects the macula, the central part of the retina needed for sharp, clear vision. There are two types of AMD, wet and dry. In dry AMD, cells in the macula die.GA may at least partly be caused by inflammation. Sirolimus helps prevent inflammation and therefore may help treat GA.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
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依托单位:
海外基金