Aflibercept, Bevacizumab, or Ranibizumab for Diabetic Macular Edema

Abstract

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. (Funded by the National Institutes of Health; ClinicalTrials.gov number, NCT01627249.)

Bevacizumab in diabetic macular edema. A retrospective analysis of the efficacy of treatment in a group of 100 patients

“…Extracting data or drawing conclusions for a shorter period of observation is not always possible. The three-month outcome of this study was slightly worse than described in the Diabetic Retinopathy Clinical Research Network study [10]. One of the reasons might be that the baseline BCVA was higher in our study 63.8 (± 26.2) vs. 56.6 (± 10.6).…”

“…Similar results have been found in our study. The safety of anti-VEGF drugs is confirmed by studies conducted on large groups of patients suffering from age-related macular disease and DME [10][11][12][19][20][21].…”

“…Most of the studies report the results after long-term treatment, i.e. 6, 12, 18, or 24 months [10][11][12]. Extracting data or drawing conclusions for a shorter period of observation is not always possible.…”

Minimally Invasive Microincision Vitrectomy Surgery with an Intraoperative Dexamethasone Implant for Refractory Diabetic Macular Edema

“…Several anti-VEGF agents, including bevacizumab, ranibizumab, and aflibercept, have become first-line therapies for DME, especially in cases that are phakic [10]. In previous phase III clinical studies, ranibizumab (RISE and RIDE) [11] and aflibercept (VISTA and VIVID) [12] demonstrated their effectiveness in the treatment of center-involving DME.…”

Intraocular Pressure Spikes after Aflibercept Intravitreal Injections

“…The repercussions on the visual field of patients who underwent many IVIs in wet ARMD or diabetic macular edema (mean of 12.6 ± 6.6 IVIs in 2 years for the as-needed group treated with ranibizumab for ARMD in the CATT Study and a median of 15 IVIs over the 2 years in the ranibizumab group for diabetic macular edema in the protocol T of the DRCR.net) remain unknown to date [4,5]. …”