This application is for a five-year extension of funding for the Diabetic Retinopathy Clinical Research Network (DRCR.net) Coordinating Center. The DRCR.net is dedicated to support multicenter clinical research of diabetic retinopathy, macular edema and associated conditions through a collaborative network utilizing specialized infrastructure resources that include a Coordination Center and Network Chair's office. The Network's primary goal is to identify, create, conduct, analyze and report high quality clinical tral protocols that lead to a better understanding of diabetic retinopathy, advance its treatment, and improve the lives of individuals with diabetes. The uniqueness of the Network and its efficiencies of scale allow the performance of protocols using money from the NIH, industry, and foundations. These protocols often involve trials that would not be done by industry and would not be feasible with solely NIH funding. These trials include comparative effectiveness studies, new indications of approved drugs, and the testing of new therapies, including Phase I and 11 clinical trials. The general goals of the DRCR.net over the next 5 year period include 1) continuing to develop protocols in a rapid and efficient manner while maintaining absolute scientific rigor and integrity, 2) continuously identifying and focusing upcoming studies on the most important medical and public health diabetes ophthalmic issues of the day and 3) continuing the legacy of innovative novel approaches to clinical trial design &implementation, network structure, and education. During the next funding cycle, the Network proposes to complete 6-8 protocols that are expected to be in progress at the time the funding period begins, initiate 10-15 new protocols (including 1-2 new major protocols per year) in diabetic retinopathy, diabetic macular edema and associated conditions, continue to expand the DRCR.net by soliciting the participation of new sites, continue to educate the DRCR.net investigators on the principles of clinical research, and mentor selected retina specialists to be leaders in clinical trials with specific reference to diabetic retinopathy.

Public Health Relevance

The prevalence of diabetes continues to grow in epidemic proportions in the U.S. and the rest of the world. As such, the most feared complication, vision loss from diabetic retinopathy, remains a significant public health problem. The DRCR Network represents a novel approach to facilitating research in this area which already has had a profound effect on the management of diabetic retinopathy, including diabetic macular edema

Agency
National Institute of Health (NIH)
Institute
National Eye Institute (NEI)
Type
Cooperative Clinical Research--Cooperative Agreements (U10)
Project #
2U10EY014231-13
Application #
8474276
Study Section
Special Emphasis Panel (ZEY1-VSN (05))
Program Officer
Schron, Eleanor
Project Start
2002-09-30
Project End
2018-12-31
Budget Start
2014-01-01
Budget End
2014-12-31
Support Year
13
Fiscal Year
2014
Total Cost
$4,500,000
Indirect Cost
$938,928
Name
Jaeb Center for Health Research, Inc.
Department
Type
DUNS #
957043193
City
Tampa
State
FL
Country
United States
Zip Code
33647
Jampol, Lee M; Bressler, Neil M; Glassman, Adam R (2014) Revolution to a new standard treatment of diabetic macular edema. JAMA 311:2269-70
Diabetic Retinopathy Clinical Research Network Writing Committee; Bressler, Susan B; Edwards, Allison R et al. (2014) Reproducibility of spectral-domain optical coherence tomography retinal thickness measurements and conversion to equivalent time-domain metrics in diabetic macular edema. JAMA Ophthalmol 132:1113-22
Diabetic Retinopathy Clinical Research Network Authors/Writing Committee; Bressler, Susan B; Baker, Carl W et al. (2014) Pilot study of individuals with diabetic macular edema undergoing cataract surgery. JAMA Ophthalmol 132:224-6
Bressler, Susan B; Almukhtar, Talat; Aiello, Lloyd P et al. (2013) Green or yellow laser treatment for diabetic macular edema: exploratory assessment within the Diabetic Retinopathy Clinical Research Network. Retina 33:2080-8
Diabetic Retinopathy Clinical Research Network Authors/Writing Committee; Baker, Carl W; Almukhtar, Talat et al. (2013) Macular edema after cataract surgery in eyes without preoperative central-involved diabetic macular edema. JAMA Ophthalmol 131:870-9
Diabetic Retinopathy Clinical Research Network* (2013) Randomized clinical trial evaluating intravitreal ranibizumab or saline for vitreous hemorrhage from proliferative diabetic retinopathy. JAMA Ophthalmol 131:283-93
Bressler, Susan B; Qin, Haijing; Melia, Michele et al. (2013) Exploratory analysis of the effect of intravitreal ranibizumab or triamcinolone on worsening of diabetic retinopathy in a randomized clinical trial. JAMA Ophthalmol 131:1033-40
Glassman, Adam R; Stockdale, Cynthia R; Beck, Roy W et al. (2012) Evaluation of masking study participants to intravitreal injections in a randomized clinical trial. Arch Ophthalmol 130:190-4
Sun, Jennifer K; Qin, Haijing; Aiello, Lloyd Paul et al. (2012) Evaluation of visual acuity measurements after autorefraction vs manual refraction in eyes with and without diabetic macular edema. Arch Ophthalmol 130:470-9
Elman, Michael J; Bressler, Neil M; Qin, Haijing et al. (2011) Expanded 2-year follow-up of ranibizumab plus prompt or deferred laser or triamcinolone plus prompt laser for diabetic macular edema. Ophthalmology 118:609-14

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