Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema

作者：Wells, John A.; Glassman, Adam R.^*; Ayala, Allison R.; Jampol, Lee M.; Aiello, Lloyd Paul; Antoszyk, Andrew N.; Arnold-Bush, Bambi; Baker, Carl W.; Bressler, Neil M.; Browning, David J.; Elman, Michael J.; Ferris, Frederick L.; Friedman, Scott M.; Melia, Michele; Pieramici, Dante J.; Sun, Jennifer K.; Beck, Roy W.

来源：New England Journal of Medicine, 2015, 372(13): 1193-1203.

DOI：10.1056/NEJMoa1414264

• ENDOTHELIAL GROWTH-FACTOR
• RETINA STUDY-GROUP
• INTRAVITREAL BEVACIZUMAB
• RETINOPATHY
• PREVALENCE
• RISK

BACKGROUND @@@ The relative efficacy and safety of intravitreous aflibercept, bevacizumab, and ranibizumab in the treatment of diabetic macular edema are unknown. @@@ METHODS @@@ At 89 clinical sites, we randomly assigned 660 adults (mean age, 61 +/- 10 years) with diabetic macular edema involving the macular center to receive intravitreous aflibercept at a dose of 2.0 mg (224 participants), bevacizumab at a dose of 1.25 mg (218 participants), or ranibizumab at a dose of 0.3 mg (218 participants). The study drugs were administered as often as every 4 weeks, according to a protocol-specified algorithm. The primary outcome was the mean change in visual acuity at 1 year. @@@ RESULTS @@@ From baseline to 1 year, the mean visual-acuity letter score (range, 0 to 100, with higher scores indicating better visual acuity; a score of 85 is approximately 20/20) improved by 13.3 with aflibercept, by 9.7 with bevacizumab, and by 11.2 with ranibizumab. Although the improvement was greater with aflibercept than with the other two drugs (P<0.001 for aflibercept vs. bevacizumab and P = 0.03 for aflibercept vs. ranibizumab), it was not clinically meaningful, because the difference was driven by the eyes with worse visual acuity at baseline (P<0.001 for interaction). When the initial visual-acuity letter score was 78 to 69 (equivalent to approximately 20/32 to 20/40) (51% of participants), the mean improvement was 8.0 with aflibercept, 7.5 with bevacizumab, and 8.3 with ranibizumab (P>0.50 for each pairwise comparison). When the initial letter score was less than 69 (approximately 20/50 or worse), the mean improvement was 18.9 with aflibercept, 11.8 with bevacizumab, and 14.2 with ranibizumab (P<0.001 for aflibercept vs. bevacizumab, P = 0.003 for aflibercept vs. ranibizumab, and P = 0.21 for ranibizumab vs. bevacizumab). There were no significant differences among the study groups in the rates of serious adverse events (P = 0.40), hospitalization (P = 0.51), death (P = 0.72), or major cardiovascular events (P = 0.56). @@@ CONCLUSIONS @@@ Intravitreous aflibercept, bevacizumab, or ranibizumab improved vision in eyes with center-involved diabetic macular edema, but the relative effect depended on baseline visual acuity. When the initial visual-acuity loss was mild, there were no apparent differences, on average, among study groups. At worse levels of initial visual acuity, aflibercept was more effective at improving vision.

• 出版日期2015-3-26
• 单位西北大学