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Special Communication |

Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema Extrapolation of Data to Clinical Practice

Jeffrey S. Heier, MD1; Neil M. Bressler, MD2,3; Robert L. Avery, MD4; Sophie J. Bakri, MD5; David S. Boyer, MD6; David M. Brown, MD7; Pravin U. Dugel, MD8,9; K. Bailey Freund, MD10; Adam R. Glassman, MS11; Judy E. Kim, MD12; Daniel F. Martin, MD13; John S. Pollack, MD14,15; Carl D. Regillo, MD16,17; Philip J. Rosenfeld, MD, PhD18; Andrew P. Schachat, MD13; John A. Wells III, MD19 ; for the American Society of Retina Specialists Anti-VEGF for Diabetic Macular Edema Comparative Effectiveness Panel
[+] Author Affiliations
1Ophthalmic Consultants of Boston, Boston, Massachusetts
2Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland
3Editor, JAMA Ophthalmology
4California Retina Consultants, Santa Barbara
5Mayo Clinic, Rochester, Minnesota
6Retina Vitreous Associates Medical Group, Keck School of Medicine of University of Southern California, Los Angeles
7Retina Consultants of Houston, Baylor College of Medicine, Houston, Texas
8Retinal Consultants of Arizona, Phoenix
9University of Southern California Eye Institute, Keck School of Medicine of University of Southern California, Los Angeles
10Vitreous-Retina-Macula Consultants of New York, New York University School of Medicine, New York
11Jaeb Center for Health Research, Tampa, Florida
12Medical College of Wisconsin, Milwaukee
13Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio
14Illinois Retina Associates, Chicago
15Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois
16Wills Eye Hospital Retina Service and Mid Atlantic Retina, Philadelphia, Pennsylvania
17Department of Ophthalmology, Thomas Jefferson University, Philadelphia, Pennsylvania
18Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida
19Palmetto Retina Center, West Columbia, South Carolina
JAMA Ophthalmol. 2016;134(1):95-99. doi:10.1001/jamaophthalmol.2015.4110.
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Importance  The Diabetic Retinopathy Clinical Research Network (DRCR Network), sponsored by the National Eye Institute, reported the results of a comparative effectiveness randomized clinical trial (RCT) evaluating the 3 anti–vascular endothelial growth factor (anti-VEGF) agents aflibercept (2.0 mg), bevacizumab (1.25 mg), and ranibizumab (0.3 mg) for treatment of diabetic macular edema (DME) involving the center of the retina and associated with visual acuity loss. The many important findings of the RCT prompted the American Society of Retina Specialists to convene a group of experts to provide their perspective regarding clinically relevant findings of the study.

Objectives  To describe specific outcomes of the RCT judged worthy of highlighting, to discuss how these and other clinically relevant results should be considered by specialists treating DME, and to identify unanswered questions that merit consideration before treatment.

Evidence Review  The DRCR Network–authored publication on primary outcomes of the comparative effectiveness RCT at 89 sites in the United States. The study period of the RCT was August 22, 2012, to August 28, 2013.

Findings  On average, all 3 anti-VEGF agents led to improved visual acuity in eyes with DME involving the center of the retina and with visual acuity impairment, including mean (SD) improvements by +13.3 (11.1) letters with aflibercept vs +9.7 (10.1) letters with bevacizumab (P < .001) and +11.2 (9.4) letters with ranibizumab (P = .03). Worse visual acuity when initiating therapy was associated with greater visual acuity benefit of aflibercept (+18.9 [11.5]) over bevacizumab (+11.8 [12.0]) or ranibizumab (14.2 [10.6]) 1 year later (P < .001 for interaction with visual acuity as a continuous variable, and P = .002 for interaction with visual acuity as a categorical variable). It is unknown whether different visual acuity outcomes associated with the use of the 3 anti-VEGF agents would be noted with other treatment regimens or with adequately repackaged bevacizumab, as well as in patients with criteria that excluded them from the RCT, such as persistent DME despite recent anti-VEGF treatment.

Conclusions and Relevance  On average, all 3 anti-VEGF agents led to improved visual acuity in eyes with DME involving the center of the retina and visual acuity impairment. Worse visual acuity when initiating therapy was associated with greater visual acuity benefit of aflibercept over bevacizumab or ranibizumab 1 year later. Care needs to be taken when attempting to extrapolate outcomes of this RCT to differing treatment regimens. With access to adequately repackaged bevacizumab, many specialists might initiate therapy with bevacizumab when visual acuity is good (ie, 20/32 to 20/40 as measured in the DRCR Network), recognizing that the cost-effectiveness of bevacizumab outweighs that of aflibercept or ranibizumab.

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