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、 美国国立卫生研究院定义的第三阶段临床试验旨在评估玻璃体腔注射(S)的安全性和有效性 曲安奈德治疗糖尿病视网膜中央病变继发黄斑水肿 静脉阻塞(CRVO)或视网膜分支静脉阻塞(BRVO)对 局灶性/网格状光凝(糖尿病黄斑水肿组和BRVO)或至少观察90天 (CRVO)。这些组中的每一组的患者将随机分配到以下组之一： 1)常规治疗(观察或重复局部/网格光凝治疗 黄斑水肿与糖尿病视网膜病变或BRVO相关；观察 与CRVO相关的黄斑水肿)，或 2)玻璃体内注射曲安奈德(S)治疗 糖尿病视网膜病变组共有186名参与者，CRVO和CRVO各有116名参与者 BRVO小组将在20-25个临床中心登记。参赛者将被跟踪24个月， 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、荧光素血管造影术和光学相干断层造影术在 基线，每隔3个月和/或6个月至24个月。主要结果是10个字母或更多 术后24个月观察ETDRS视力改善情况。 此应用程序旨在建立一个数据协调中心(DCC)，该中心将提供领导和 需要合作才能成功实施ICME研究。作为DCC，EMMES公司 将参与ICME研究设计和管理的方方面面，包括协议 开发和实施，开发数据管理系统，确保保护人 受试者，为数据和安全监测委员会提供支持，以进行研究监督，并提供 为研究结果的传播提供统计支持。EMMES在以下方面拥有广泛的经验 协调多中心临床试验，我们有信心有能力协调ICME研究 根据美国国立卫生研究院发起的研究的最高标准。 Performmanceite(S)(组织、市、州) The EMMESC公司R，马里兰州洛克维尔 关键人员。请参阅说明。根据需要使用第二页，以如下所示的格式提供所需信息。 从首席调查员开始。按字母顺序列出其他关键人员，姓氏在前。 名称组织角色项目 VanVeldhuisenP，AUL，M.S.EMMES首席调查员 戴利，伦纳德，M.Sc。EMMESCORANCE统计学家 Entler，Gary The EMMESCorporation ProtocolMonitor 琳德、利亚、M.P.H.《EMMESCoration ProtocolMonitor》 Lindblad，Anne，Ph.D.和EMME公司副主管 总统 奥登，尼尔，博士，EMMESC统计学家 ThotapallyK，Umar TheEMMESC公司程序员/分析师 Tomlin，Kate，M.A.EMMES公司行政协调员 威廉姆斯，Ikki TheEMMESCorporation数据库经理 =_{_L_r_Pe_r_os_n声明。A？pp“许可SBIR/STTROnl-y。请参阅_m‘asgtreu_ctz Lons.I I Yes II No Form page2= Numberpagesconsecutivelyatthebottomthroughoutheapplication.Do不使用3a、3b。 范·维尔德怀森，保罗·马歇尔 []首席调查员/方案主任(最后、第一、中间)‘。 必须在每张打印页和每张续页的顶部提供首席调查员/方案主任的姓名。 研究补助金 目录 页码 主页.......................................................................................................................1 描述，

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,