The primary objective ofthe activities proposed in this appHcation is to provide optical coherence tomography (OCT) Reading Center support to the Comparison of Age Related Macular Degeneration Treatment trial (CATT) duringthe conclusion of the CATT rsndomized clinical trial phase, and for the subsequent 3-year follow-up phase. The long term goals of this project, that will be accomplished through conduct of CATT are 1) to identify by OCT those eyes that are most likely to benefit from treatment in eyes with AMD, 2) to determine by OCT when treatment is effective or re-treatment is required and 3) to standardize OCT protocols and grading methods in eyes with AMD. 4) To determine OCT parameters that reflect long-term safety and efficacy ofAMD treatment as administered in CATT. The primary objective will be accomplished through the following specific aims:
SPECIFIC AIM 1 : Provide the infrastructure to process OCT images that will be submitted by CATT study sites to the CATT OCT Reading Center during the remainder of the randomized clinical trial and follow-up phase SPECIFIC AIM 2: Certify and train CATT study personnel during the remainder of the randomized clinical trial and follow-up phase.
SPECIFIC AIM 3 : Provide Reliable, Timely, Reproducible, and Systematic Grading of Submitted OCT Material during the remainder ofthe clinical trial and follow-up phase. To achieve these aims, The OCT Reading Center will use a custom, stand-alone web-based system that we have developed to establish and implement secure methods for electronic time-domain and spectral-domain OCT data submission from the CATT clinical study sites to the CATT OCT Reading Center, and to store and back-up submitted data. We will use secure methods to transmit data from the OCT Reading Center to the Coordinating Center. We will develop custom software to quantify retinal and sub-retinal lesion area to monitor thickness changes over time. The Reading Center will also implement materials and methods for reader, OCT technician, clinical coordinator and ophthalmologist certification training, and will support study goals as an image resource for recruitment. Study Group meetings, presentations and pulications.

Public Health Relevance

; The funds requested in this application will allow successful completion of the randomiszed clinical trial phase of CATT, and will provide critical safety and efficacy information during the follow-up phase. Results from this trial, which will affect hundreds of thousands of patients with neovascular age-related macular degeneration, will provide the basis for doctors and patients to choose between two different drugs and treatment nians DeDendina on the results. Medicare could save more than $1 billion per vear.

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
5U10EY017825-08
Application #
8415891
Study Section
Special Emphasis Panel (ZEY1-VSN (01))
Program Officer
Redford, Maryann
Project Start
2006-09-30
Project End
2013-08-31
Budget Start
2013-02-01
Budget End
2013-08-31
Support Year
8
Fiscal Year
2013
Total Cost
$64,511
Indirect Cost
$23,421
Name
Duke University
Department
Ophthalmology
Type
Schools of Medicine
DUNS #
044387793
City
Durham
State
NC
Country
United States
Zip Code
27705
Ying, Gui-shuang; Kim, Benjamin J; Maguire, Maureen G et al. (2014) Sustained visual acuity loss in the comparison of age-related macular degeneration treatments trials. JAMA Ophthalmol 132:915-21
Daniel, Ebenezer; Toth, Cynthia A; Grunwald, Juan E et al. (2014) Risk of scar in the comparison of age-related macular degeneration treatments trials. Ophthalmology 121:656-66
Folgar, Francisco A; Jaffe, Glenn J; Ying, Gui-Shuang et al. (2014) Comparison of optical coherence tomography assessments in the comparison of age-related macular degeneration treatments trials. Ophthalmology 121:1956-65
Hagstrom, Stephanie A; Ying, Gui-shuang; Pauer, Gayle J T et al. (2014) VEGFA and VEGFR2 gene polymorphisms and response to anti-vascular endothelial growth factor therapy: comparison of age-related macular degeneration treatments trials (CATT). JAMA Ophthalmol 132:521-7
Hagstrom, Stephanie A; Ying, Gui-Shuang; Pauer, Gayle J T et al. (2014) Endothelial PAS domain-containing protein 1 (EPAS1) gene polymorphisms and response to anti-VEGF therapy in the comparison of AMD treatments trials (CATT). Ophthalmology 121:1663-4.e1
Kim, Benjamin J; Ying, Gui-Shuang; Huang, Jiayan et al. (2014) Sporadic visual acuity loss in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol 158:128-135.e10
Gewaily, Dina Y; Grunwald, Juan E; Pistilli, Maxwell et al. (2014) Delayed patchy choroidal filling in the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT). Am J Ophthalmol 158:525-31.e2
Lee, Joo Yong; Folgar, Francisco A; Maguire, Maureen G et al. (2014) Outer retinal tubulation in the comparison of age-related macular degeneration treatments trials (CATT). Ophthalmology 121:2423-31
Hagstrom, Stephanie A; Ying, Gui-Shuang; Pauer, Gayle J T et al. (2013) Pharmacogenetics for genes associated with age-related macular degeneration in the Comparison of AMD Treatments Trials (CATT). Ophthalmology 120:593-9
Jaffe, Glenn J; Martin, Daniel F; Toth, Cynthia A et al. (2013) Macular morphology and visual acuity in the comparison of age-related macular degeneration treatments trials. Ophthalmology 120:1860-70

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