Intravitreal Corticosteroid for Macular Edema

玻璃体内皮质类固醇治疗黄斑水肿（ICME）研究是一项多中心、前瞻性、随机、 NIH定义的III期临床试验，旨在评估玻璃体内注射 曲安奈德治疗继发于糖尿病视网膜病变的黄斑水肿 视网膜静脉阻塞（CRVO）或视网膜分支静脉阻塞（BRVO）， 局灶/网格光凝（糖尿病黄斑水肿组和BRVO）或至少观察90天 （CRVO）。这些组中的患者将被随机分配至以下组之一： 1)常规治疗（观察或重复局灶性/网格光凝） 糖尿病视网膜病变或BRVO相关性黄斑水肿;观察 与CRVO相关的黄斑水肿），或 2)玻璃体内注射曲安奈德治疗 糖尿病视网膜病变组共有186名参与者，CRVO和CRVO各116名参与者。 BRVO组将在20-25家临床中心入组。患者将接受24个月的随访， 评估包括早期治疗糖尿病视网膜病变研究（ETDRS）视力评分， 立体眼底照相术、荧光素血管造影术和光学相干断层扫描， 基线和3个月和/或6个月的时间间隔至24个月。主要结果是10个字母或更多 24个月时评估ETDRS视力改善。 本申请旨在建立一个数据协调中心（DCC），该中心将提供领导和 成功实施ICME研究所需的协作。作为DCC，EMME认证 将参与ICME研究设计和管理的所有方面，包括方案 开发和实施，开发数据管理系统，确保保护人类 受试者，为数据和安全审查委员会提供研究监督支持，并提供 为传播研究结果提供统计支持。EMMES拥有广泛的经验基础， 协调多中心临床试验，我们有信心有能力协调ICME研究 根据NIH资助研究的最高标准。 地点（组织、城市、州） 马里兰州，奥克维尔， 关键人员。参见说明。根据需要使用续页，以下列格式提供所需信息。 从主要研究者开始，按字母顺序列出其他关键人员，姓在前。 名称组织机构项目 VanVeldhuisen P，aul，M.S. EMME认证主要研究者 伦纳德达利，理学硕士，《埃梅斯大学统计学家》 Entler，加里EMMESCDMA协议监视器 林德、利亚、公共卫生硕士EMME加密协议监视器 Lindblad，Anne，Ph.D. and Vice The EMMESCellation Corporation oversight 总统 Oden，Neal，博士EMMESCreenation统计员 ThotapallyK，umar TheEMMESComplification Programmer/Analyst Tomlin，Kate，文学硕士EMME认证管理协调员 WilliamsN，ikki电子邮件数据库经理 =_{_l_r_Pe_r_os_n语句。SBIR/STTROnl-y.参见_m 'asgtreu_ctzLons.I I是II否表格第2页= 编号页在整个应用程序的底部。不要使用诸如3a，3b之类的固定值。 VanVeldhuisen，Paul MS []主要研究者/项目主管（最后，第一，中间）。 主要研究者/项目负责人的姓名必须在打印页和续页的顶部提供。 研究资助 目录 页码 首页... 1 说明，

The IntravitrealCorticosteroidfor Macular Edema(ICME) Study is a multi-center,prospective, randomized, NIH-definedPhase III clinical trial designedto assess the safety and efficacy of intravitreal injection(s) of triamcinoloneacetonide in patientswith macular edema secondaryto diabetic retinopathy,central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO)who have failed to respondfavorably to focal/grid photocoagulation (diabeticmacular edema group and BRVO) or at least 90 days of observation (CRVO). Patients in each of these groupswill be randomlyassigned to one of the following: 1) conventionaltreatment (observationor repeat focal/gridphotocoagulationfor patients with macular edema associatedwith diabetic retinopathyor BRVO; observationfor patients with macular edema associatedwith CRVO),or 2) treatment with intravitreal injection(s)of triamcinoloneacetonide A total of 186participants inthe diabetic retinopathygroup and 116 participantsin each of the CRVO and BRVO groups will be enrolled at 20-25 clinical centers. Participantswill be followed for 24 months, with assessments includingEarly Treatment Diabetic RetinopathyStudy (ETDRS)visual acuity score, stereoscopicfundus photography,fluorescein angiographyand optical coherencetomography performed at baseline and at 3 and/or 6 month intervalsthrough 24 months. The primary outcome is a 10 letter or more improvementin ETDRS visual acuity assessedat 24 months. This application is to establisha Data CoordinatingCenter (DCC) that will provide the leadershipand collaboration requiredto successfully implementthe ICMEstudy. As the DCC,The EMMESCorporation will be involved in all aspects of the ICMEstudy design and management,which includesprotocol development and implementation,developingdata managementsystems,ensuring protection of human subjects, providingsupport to a Data and Safety MonitoringBoardfor study oversight,and providing statistical support for the dissemination of study results. EMMEShas a broad base of experience in coordinating multi-centerclinical trials and we are confident of our ability to coordinatethe ICMEstudy according to the highest standards of NIH-sponsoredresearch. PERFORMANCESITE(S) (organization,city, state) TheEMMESCorporationR, ockville,Maryland KEY PERSONNEL. See instructions. Usecontinuationpages as neededto providethe requiredinformation in the format shown below. Startwith PrincipalInvestigator.Listall other key personnelin alphabetical order,last namefirst. Name Organization Roleon Project VanVeldhuisenP, aul,M.S. The EMMESCorporation PrincipalInvestigator Dally,Leonard,M.Sc. The EMMESCorporation Statistician Entler,Gary The EMMESCorporation ProtocolMonitor Lind,Leah,M.P.H. The EMMESCorporation ProtocolMonitor Lindblad,Anne,Ph.D.andVice The EMMESCorporation Corporateoversight President Oden,Neal,Ph.D. TheEMMESCorporation Statistician ThotapallyK, umar TheEMMESCorporation Programmer/Analyst Tomlin,Kate,M.A. TheEMMESCorporation AdministrativeCoordinator WilliamsN, ikki TheEMMESCorporation DatabaseManager =_{_l_r_Pe_r_os_n Statement. A¿pp" licableto SBIR/STTROnl-y. See _m'asgtreu_ctzLons.I I Yes II No Form Page2 = Numberpagesconsecutivelyatthebottomthroughoutheapplication.Do notusesuffixessuchas 3a, 3b. VanVeldhuisen, Paul MS [] Principal Investigator/ProgramDirector(Last,first, middle)'. The nameof the principalinvestigator/programdirector must be provided at the top of each printed page and each continuation page. RESEARCH GRANT TABLE OF CONTENTS Page Numbers Face Page ............................................................................................................................................ 1 Description,