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Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice.
JAMA Ophthalmol. 2016 Jan; 134(1):95-9.JO

Abstract

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.

Authors+Show Affiliations

Ophthalmic Consultants of Boston, Boston, Massachusetts.Wilmer Eye Institute, The Johns Hopkins University School of Medicine, Baltimore, Maryland3Editor, JAMA Ophthalmology.California Retina Consultants, Santa Barbara.Mayo Clinic, Rochester, Minnesota.Retina Vitreous Associates Medical Group, Keck School of Medicine of University of Southern California, Los Angeles.Retina Consultants of Houston, Baylor College of Medicine, Houston, Texas.Retinal Consultants of Arizona, Phoenix9University of Southern California Eye Institute, Keck School of Medicine of University of Southern California, Los Angeles.Vitreous-Retina-Macula Consultants of New York, New York University School of Medicine, New York.Jaeb Center for Health Research, Tampa, Florida.Medical College of Wisconsin, Milwaukee.Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.Illinois Retina Associates, Chicago15Department of Ophthalmology, Rush University Medical Center, Chicago, Illinois.Wills Eye Hospital Retina Service and Mid Atlantic Retina, Philadelphia, Pennsylvania17Department of Ophthalmology, Thomas Jefferson University, Philadelphia, Pennsylvania.Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Miami, Florida.Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio.Palmetto Retina Center, West Columbia, South Carolina.No affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

26512939

Citation

Heier, Jeffrey S., et al. "Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice." JAMA Ophthalmology, vol. 134, no. 1, 2016, pp. 95-9.
Heier JS, Bressler NM, Avery RL, et al. Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice. JAMA Ophthalmol. 2016;134(1):95-9.
Heier, J. S., Bressler, N. M., Avery, R. L., Bakri, S. J., Boyer, D. S., Brown, D. M., Dugel, P. U., Freund, K. B., Glassman, A. R., Kim, J. E., Martin, D. F., Pollack, J. S., Regillo, C. D., Rosenfeld, P. J., Schachat, A. P., & Wells, J. A. (2016). Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice. JAMA Ophthalmology, 134(1), 95-9. https://doi.org/10.1001/jamaophthalmol.2015.4110
Heier JS, et al. Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice. JAMA Ophthalmol. 2016;134(1):95-9. PubMed PMID: 26512939.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Comparison of Aflibercept, Bevacizumab, and Ranibizumab for Treatment of Diabetic Macular Edema: Extrapolation of Data to Clinical Practice. AU - Heier,Jeffrey S, AU - Bressler,Neil M, AU - Avery,Robert L, AU - Bakri,Sophie J, AU - Boyer,David S, AU - Brown,David M, AU - Dugel,Pravin U, AU - Freund,K Bailey, AU - Glassman,Adam R, AU - Kim,Judy E, AU - Martin,Daniel F, AU - Pollack,John S, AU - Regillo,Carl D, AU - Rosenfeld,Philip J, AU - Schachat,Andrew P, AU - Wells,John A,3rd AU - ,, PY - 2015/10/30/entrez PY - 2015/10/30/pubmed PY - 2016/6/21/medline SP - 95 EP - 9 JF - JAMA ophthalmology JO - JAMA Ophthalmol VL - 134 IS - 1 N2 - 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. SN - 2168-6173 UR - https://www.unboundmedicine.com/medline/citation/26512939/Comparison_of_Aflibercept_Bevacizumab_and_Ranibizumab_for_Treatment_of_Diabetic_Macular_Edema:_Extrapolation_of_Data_to_Clinical_Practice_ L2 - https://jamanetwork.com/journals/jamaophthalmology/fullarticle/10.1001/jamaophthalmol.2015.4110 DB - PRIME DP - Unbound Medicine ER -