Intravitreal Corticosteroid for Macular Edema

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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,