TY - JOUR
T1 - Early Response to Anti–Vascular Endothelial Growth Factor and Two-Year Outcomes Among Eyes With Diabetic Macular Edema in Protocol T
AU - Diabetic Retinopathy Clinical Research Network
AU - Bressler, Neil M.
AU - Beaulieu, Wesley T.
AU - Maguire, Maureen G.
AU - Glassman, Adam R.
AU - Blinder, Kevin J.
AU - Bressler, Susan B.
AU - Gonzalez, Victor H.
AU - Jampol, Lee M.
AU - Melia, Michele
AU - Sun, Jennifer K.
AU - Wells, John A.
N1 - Funding Information:
Funding/Support: Supported through a cooperative agreement from the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases , National Institutes of Health, U.S. Department of Health and Human Services EY14231 , EY23207 , EY18817 . The funding organization (National Institutes of Health) participated in oversight of the conduct of the study and review of the manuscript but not directly in the design or conduct of the study, nor in the collection, management, analysis, or interpretation of the data, nor in the preparation of the manuscript. Additional Contributions: Regeneron Pharmaceuticals, Inc. provided the aflibercept and Genentech, Inc (now part of F. Hoffmann-La Roche, Ltd) provided the ranibizumab for the study. Genentech, Inc also provided funding for blood pressure cuffs and the collection of serum and urine, which are not part of the study results reported herein. As per the DRCR.net Industry Collaboration Guidelines (available at www.drcr.net ), the DRCR.net had complete control over the design of the protocol, ownership of the data, and all editorial content of presentations and publications related to the protocol. Genentech, Inc has provided funds restricted to DRCR.net clinical sites. Financial Disclosures: Neil M. Bressler: Alkeus, American Medical Association, Bayer, Chiltern Intl Inc, Novartis, Roche, Samsung (Grants). Wesley T. Beaulieu: Regeneron, Genentech (Grants). Maureen G. Maguire: Genentech/Roche (honoraria). Adam R. Glassman: Regeneron, Genentech (Grants). Kevin J. Blinder: Regeneron, Allergan, Bausch & Lomb (Consultancy). Susan B. Bressler: Bayer, Boehringer Ingelheim, Novartis, Roche, Merck (Grants). Victor H. Gonzalez: Regeneron (Grants, Speaker, Consultant), Genentech (Grants, Speaker, Consultant). Lee M. Jampol: Quintiles/Stem Cell Organization (Consultancy). Jennifer K. Sun: Genenteh (Grants), OptoVUE, Inc (Other), Novo Nordisk (Travel, Metting Expenses), Kalvista (Grants), Boehringer-Ingelheim (Grants), Adaptive Sensory Technology (Other), Boston Micromachines (Other), Current Diabetes Reports (Board Membership), JAMA Ophthalmology (Board Membership, payments for manuscript preparation), Adaptive Sensory Technology (Grants). John A. Wells, III: Genentech (Consultancy, clinical or lab research grants, development of presentations). Opthea, Kalvista, Ohr Pharm, NIH (Grants). Iconic Pharm. (Consultancy); Regeneron (Grants). The following author has no financial disclosures: Michele Melia. All authors attest that they meet the current ICMJE criteria for authorship.
Publisher Copyright:
© 2018 Elsevier Inc.
PY - 2018/11
Y1 - 2018/11
N2 - Purpose: Assess associations of 2-year visual acuity (VA) outcomes with VA and optical coherence tomography central subfield thickness (CST) after 12 weeks of anti–vascular endothelial growth factor treatment for diabetic macular edema in DRCR.net Protocol T. Design: Randomized clinical trial. Methods: SETTING: Multicenter (89 U.S. sites). PATIENT POPULATION: Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3%]). INTERVENTION: Six monthly injections of 2.0 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab; subsequent injections and focal/grid laser as needed for stability. MAIN OUTCOME MEASURES: Change in VA from baseline and VA letter score at 2 years. Results: Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P <.001) but with substantial individual variability (multivariable R2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively). Among eyes with less than 5-letter gain at 12 weeks, the percentages of eyes gaining 10 or more letters from baseline at 2 years were 42% (20 of 48), 31% (21 of 68), and 47% (28 of 59), and median 2-year VA was 20/32, 20/32, and 20/25, in the aflibercept, bevacizumab, and ranibizumab groups, respectively. Twelve-week CST response was not strongly associated with 2-year outcomes. Conclusions: A suboptimal response at 12 weeks did not preclude meaningful vision improvement (ie, ≥ 10-letter gain) in many eyes at 2 years. Eyes with less than 5-letter gain at 12 weeks often had good VA at 2 years without switching therapies.
AB - Purpose: Assess associations of 2-year visual acuity (VA) outcomes with VA and optical coherence tomography central subfield thickness (CST) after 12 weeks of anti–vascular endothelial growth factor treatment for diabetic macular edema in DRCR.net Protocol T. Design: Randomized clinical trial. Methods: SETTING: Multicenter (89 U.S. sites). PATIENT POPULATION: Eyes with VA and CST data from baseline and 12-week visits (616 of 660 eyes randomized [93.3%]). INTERVENTION: Six monthly injections of 2.0 mg aflibercept, 1.25 mg bevacizumab, or 0.3 mg ranibizumab; subsequent injections and focal/grid laser as needed for stability. MAIN OUTCOME MEASURES: Change in VA from baseline and VA letter score at 2 years. Results: Twelve-week VA response was associated with 2-year change in VA and 2-year VA letter score for each drug (P <.001) but with substantial individual variability (multivariable R2 = 0.38, 0.29, and 0.26 for 2-year change with aflibercept, bevacizumab, and ranibizumab, respectively). Among eyes with less than 5-letter gain at 12 weeks, the percentages of eyes gaining 10 or more letters from baseline at 2 years were 42% (20 of 48), 31% (21 of 68), and 47% (28 of 59), and median 2-year VA was 20/32, 20/32, and 20/25, in the aflibercept, bevacizumab, and ranibizumab groups, respectively. Twelve-week CST response was not strongly associated with 2-year outcomes. Conclusions: A suboptimal response at 12 weeks did not preclude meaningful vision improvement (ie, ≥ 10-letter gain) in many eyes at 2 years. Eyes with less than 5-letter gain at 12 weeks often had good VA at 2 years without switching therapies.
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U2 - 10.1016/j.ajo.2018.07.030
DO - 10.1016/j.ajo.2018.07.030
M3 - Article
C2 - 30077569
AN - SCOPUS:85052868070
VL - 195
SP - 93
EP - 100
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
ER -