The Intravitreal Corticosteroid for Macular Edema (ICME) Study is a multi-center, prospective, randomized, NIH-defined Phase III clinical trial designed to assess the safety and efficacy of intravitreal injection(s) of triamcinolone acetonide in patients with macular edema secondary to diabetic retinopathy, central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO) who have failed to respond favorably to focal/grid photocoagulation (diabetic macular edema group and BRVO) or at least 90 days of observation (CRVO). Patients in each of these groups will be randomly assigned to one of the following: 1) conventional treatment (observation or repeat focal/grid photocoagulation for patients with macular edema associated with diabetic retinopathy or BRVO; observation for patients with macular edema associated with CRVO), or 2) treatment with intravitreal injection(s) of triamcinolone acetonide A total of 186 participants in the diabetic retinopathy group and 116 participants in each of the CRVO and BRVO groups will be enrolled at 20-25 clinical centers. Participants will be followed for 24 months, with assessments including Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity score, stereoscopic fundus photography, fluorescein angiography and optical coherence tomography performed at baseline and at 3 and/or 6 month intervals through 24 months. The primary outcome is a 10 letter or more improvement in ETDRS visual acuity assessed at 24 months. This application is to establish a Data Coordinating Center (DCC) that will provide the leadership and collaboration required to successfully implement the ICME study. As the DCC, The EMMES Corporation will be involved in all aspects of the ICME study design and management, which includes protocol development and implementation, developing data management systems, ensuring protection of human subjects, providing support to a Data and Safety Monitoring Board for study oversight, and providing statistical support for the dissemination of study results. EMMES has a broad base of experience in coordinating multi-center clinical trials and we are confident of our ability to coordinate the ICME study according to the hi hest standards of NIH-sponsored research.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY014404-03
Application #
6901852
Study Section
Special Emphasis Panel (ZEY1-VSN (03))
Program Officer
Redford, Maryann
Project Start
2003-05-01
Project End
2008-04-30
Budget Start
2005-05-01
Budget End
2007-04-30
Support Year
3
Fiscal Year
2005
Total Cost
$923,949
Indirect Cost
Name
Emmes Corporation
Department
Type
DUNS #
096360284
City
Rockville
State
MD
Country
United States
Zip Code
20850
Aref, Ahmad A; Scott, Ingrid U; Oden, Neal L et al. (2015) Incidence, Risk Factors, and Timing of Elevated Intraocular Pressure After Intravitreal Triamcinolone Acetonide Injection for Macular Edema Secondary to Retinal Vein Occlusion: SCORE Study Report 15. JAMA Ophthalmol 133:1022-9
Weinberg, David V; Wahle, Aimee E; Ip, Michael S et al. (2013) Score Study Report 12: Development of venous collaterals in the Score Study. Retina 33:287-95
Scott, Ingrid U; Vanveldhuisen, Paul C; Oden, Neal L et al. (2012) Baseline characteristics and response to treatment of participants with hemiretinal compared with branch retinal or central retinal vein occlusion in the standard care vs corticosteroid for retinal vein occlusion (SCORE) study: SCORE study report 14. Arch Ophthalmol 130:1517-24
Chan, Clement K; Ip, Michael S; Vanveldhuisen, Paul C et al. (2011) SCORE Study report #11: incidences of neovascular events in eyes with retinal vein occlusion. Ophthalmology 118:1364-72
Scott, Ingrid U; VanVeldhuisen, Paul C; Oden, Neal L et al. (2011) Baseline predictors of visual acuity and retinal thickness outcomes in patients with retinal vein occlusion: Standard Care Versus COrticosteroid for REtinal Vein Occlusion Study report 10. Ophthalmology 118:345-52
Oden, Neal; Vanveldhuisen, Paul C; Scott, Ingrid U et al. (2010) SCORE Study Report 8: Closed Tests for All Pair-Wise Comparisons of Means. Drug Inf J 44:405-420
Blodi, Barbara A; Domalpally, Amitha; Scott, Ingrid U et al. (2010) Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) Study system for evaluation of stereoscopic color fundus photographs and fluorescein angiograms: SCORE Study Report 9. Arch Ophthalmol 128:1140-5
Domalpally, Amitha; Blodi, Barbara A; Scott, Ingrid U et al. (2009) The Standard Care vs Corticosteroid for Retinal Vein Occlusion (SCORE) study system for evaluation of optical coherence tomograms: SCORE study report 4. Arch Ophthalmol 127:1461-7
Ip, Michael S; Oden, Neal L; Scott, Ingrid U et al. (2009) SCORE Study report 3: study design and baseline characteristics. Ophthalmology 116:1770-1777.e1
Scott, Ingrid U; Oden, Neal L; VanVeldhuisen, Paul C et al. (2009) SCORE Study Report 7: incidence of intravitreal silicone oil droplets associated with staked-on vs luer cone syringe design. Am J Ophthalmol 148:725-732.e7

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