MUST Competitive Renewal
MUST Competitive Renewal
批准号:
8655155
负责人:
MICHAEL M ALTAWEEL
金额:
$21.24万
依托单位国家:
美国
项目类别:
财政年份:
2004
资助国家:
美国
项目状态:
已结题
起止时间:
2004-07-15 至 2017-04-30
关键词:
Adrenal Cortex HormonesAdverse effectsAngiographyAutoimmune ProcessBlindnessCataractCharacteristicsChoroidal NeovascularizationChronicChronic DiseaseClinicalClinical ManagementClinical ResearchClinical TrialsClinical Trials NetworkCollaborationsColorDataDevelopmentDiseaseEffectivenessEpidemiologic StudiesEpiretinal MembraneEvaluationEye diseasesFDA approvedFeedbackFluocinolone AcetonideFluoresceinFluorescein AngiographyFundingFundusFundus photographyGlaucomaGoalsGroup StructureHumiraImageImage AnalysisImaging TechniquesImmunosuppressionImmunosuppressive AgentsImplantInflammationInflammatoryInstructionLaboratoriesLeadershipLocal TherapyLucentisModalityMonitorMonoclonal AntibodiesMorbidity - disease rateOptical Coherence TomographyOralOutcomeOutcomes ResearchPanuveitisPatient AgentsPatientsPharmaceutical PreparationsPharmacotherapyPhasePilot ProjectsPreparationPrincipal InvestigatorProceduresProcessProtocols documentationPublicationsRandomized Controlled Clinical TrialsReactionReadingRelative (related person)ReportingResearchResearch PersonnelResourcesRetinalRetinal NeovascularizationSafetySan FranciscoScanningSeriesSeveritiesSteroidsSystemic TherapyTrainingTriamcinoloneTriamcinolone AcetonideTumor Necrosis Factor-alphaUnited StatesUniversitiesUveitisVascular DiseasesVascular Endothelial Growth FactorsVisionVisualVisual impairmentWisconsinadalimumabage relatedcohortcomparative efficacycomparative trialcompare effectivenessdesigneffective therapyevidence basefollow-uphigh riskhuman monoclonal antibodiesimprovedinhibitor/antagonistlensmacular edemanovelrandomized trialranibizumabresearch studystandard carestereoscopictherapy designtreatment trialtrial comparingyoung adult
中文摘要
在美国,中间、后部和全葡萄膜炎是导致视力丧失和失明的主要原因。
由于发病高峰在青壮年,葡萄膜炎导致的视力丧失将对
与年龄相关的眼病相比,每个病例的潜在视力损失更多。这些疾病大多是慢性的,需要
长期治疗。目前的治疗方法通常包括使用口服皮质类固醇,辅以
在特定情况下使用免疫抑制药物。北极星!资助的必选试验正在比较疗效和
与标准治疗相比,使用氟康奈德眼内植入物的发病率
这类患者的全身皮质类固醇和免疫抑制药物。有价值的数据
聚集在一起将影响治疗选择。必须2号试验将跟随这组人再进行6年,
提供有关严重葡萄膜炎的长期视觉和形态影响的客观信息
关于慢性疾病的最佳治疗的进一步指导。阿达利单抗,一种肿瘤坏死因子抑制剂,
抑制炎症性疾病的炎症反应,提供了一种新的潜在有效的方法
葡萄膜炎的处理方法。一项方案将比较两种药物的疗效和发病率(眼部和全身)。
阿达利单抗与皮质类固醇和标准免疫抑制药物治疗严重葡萄膜炎。一个共同的原因
葡萄膜炎中的视力丧失是黄斑水肿的发展过程。发现对视网膜有效的治疗方法
血管疾病已被应用于葡萄膜炎相关性黄斑水肿的治疗,但没有
足够的证据支持它们的继续使用或有关安全性的长期数据。两次试验将
评价玻璃体腔内注射曲安奈德(曲安奈德)的疗效和安全性
曲安奈德、雷尼比单抗玻璃体腔内注射与曲安奈德玻璃体腔注射治疗葡萄膜炎黄斑水肿。
这将是第一个正确指导我们对这种常见临床的进一步治疗的随机试验。
实体。该应用程序支持创建学习网络,该网络包括一个阅读中心,能够
客观评价葡萄膜炎及其并发症引起的眼部形态改变。这个资源中心
将参与网络研究的设计、实施、分析和报告。
相关性(请参阅说明):
葡萄膜炎是视力受损的一个主要原因,需要用全身和/或眼科疗法进行慢性治疗。
这可能会导致严重的发病率。旨在改善结果的新疗法,同时限制不良反应
作用包括氟西酮植入剂、玻璃体内类固醇、玻璃体内雷尼比单抗和阿达利单抗。
支持这种疗法的证据有限。随机试验将阐明适当的处理方法。
英文摘要
intermediate, posterior, and panuveitis are major causes of vision loss and blindness in the United States.
With a peak onset in young adulthood, vision loss due to uveitis will have a greater impact on years of
potential vision lost per case than age-related eye diseases. Most of these diseases are chronic and require
long-term treatment. Current therapy typically involves the use of oral corticosteroids, supplemented by
immunosuppressive drugs in selected situations. The NE! funded MUST trial is comparing the efficacy and
morbidity associated with the use of fluocinolone acetonide intraocular implant versus standard therapy with
systemic corticosteroids and immunosuppressive medications for such patients. Valuable data being
gathered will influence treatment choices. The MUST 2 trial will follow this group for another 6 years,
providing objective information regarding the long-term visual and morphologic effects of severe uveitis and
further guidance regarding the best management for a chronic disorder. Adalimumab, a TNF inhibitor that
downregulates the inflammatory reaction in inflammatory diseases, provides a novel and potentially effective
approach to managing uveitis. One protocol will compare the efficacy and morbidity (ocular and systemic) of
adalimumab versus corticosteroids and standard immunosuppression for severe uveitis. A common cause of
vision loss in uveitis is the development of macular edema. Modalities of treatment found effective for retinal
vascular disease have been applied to management of uveitis-related macular edema but do not have
sufficient evidence to support their continued use or longterm data regarding safety. Two trials would
evaluate the efficacy and safety of intravitreal triamcinolone (Triessence) versus standard subtenons
triamcinolone, and intravitreal ranibizumab versus intravitreal triamcinolone for uveitic macular edema.
These would be the first randomized trials to properly direct our further management of this common clinical
entity. This application supports the creation of a study network that includes a Reading center capable of
objectively assessing morphologic ocular changes due to uveitis and it's complications. This resource center
will participate in the design, conduct, analysis and reporting of the network studies.
RELEVANCE (See instructions):
Uveitis is a major cause of visual impairment, requiring chronic treatment with systemic and/or ocular therapy
that may induce significant morbidity. Newer treatments designed to improve outcome while limiting adverse
effects include the fluocinilone implant, intravitreal steroids, intravitreal ranibizumab, and Adalimumab.
Evidence supporting such treatments is limited. Randomized trials will elucidate appropriate management.
期刊论文(0)
专著(0)
科研奖励(0)
会议论文
Macular Edema Treatment Trials Associated with MUST (META-MUST)
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批准号:9553782
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项目类别:
-
资助金额:$27.26万
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财政年份:2014
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
Macular Edema Treatment Trials Associated with MUST (META-MUST)
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批准号:9338250
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项目类别:
-
资助金额:$26.74万
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财政年份:2014
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
Macular Edema Treatment Trials Associated with MUST (META-MUST)
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批准号:8927648
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项目类别:
-
资助金额:$20.1万
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财政年份:2014
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
Macular Edema Treatment Trials Associated with MUST (META-MUST)
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批准号:8743384
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项目类别:
-
资助金额:$16.02万
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财政年份:2014
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
Macular Edema Treatment Trials Associated with MUST (META-MUST)
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批准号:9113668
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项目类别:
-
资助金额:$21.14万
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财政年份:2014
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负责人:MICHAEL M ALTAWEEL
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依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:7100212
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项目类别:
-
资助金额:$19.1万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
-
依托单位:
MUST Competitive Renewal
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批准号:8849445
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项目类别:
-
资助金额:$21.24万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
-
依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:7266841
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项目类别:
-
资助金额:$17.52万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
-
依托单位:
MUST Competitive Renewal
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批准号:8546002
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项目类别:
-
资助金额:$2.85万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
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依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:7433807
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项目类别:
-
资助金额:$23.51万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
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依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:6922759
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项目类别:
-
资助金额:$11.2万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
-
依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:6602188
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项目类别:
-
资助金额:$18.87万
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财政年份:2004
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
MUST Competitive Renewal
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批准号:8018317
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项目类别:
-
资助金额:$18.38万
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财政年份:2004
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负责人:MICHAEL M ALTAWEEL
-
依托单位:
MUST Competitive Renewal
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批准号:8459390
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项目类别:
-
资助金额:$21.24万
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财政年份:2004
-
负责人:MICHAEL M ALTAWEEL
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依托单位:
Reading Center: Multicenter Uveitis Steroid Trial
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批准号:7809032
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项目类别:
-
资助金额:$48.46万
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财政年份:2004
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负责人:MICHAEL M ALTAWEEL
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依托单位:
海外基金