Visual acuity outcomes and anti-VEGF therapy intensity in diabetic macular oedema: a real-world analysis of 28 658 patient eyes

Abstract

Background/AimTo assess visual acuity (VA) outcomes and antivascular endothelial growth factor (anti-VEGF) treatment intensity in diabetic macular oedema (DMO).MethodsRetrospective analysis was performed in treatment-naïve patients with DMO from 2013 to 2018 using a database of aggregated de-identified electronic medical records (Vestrum Health).ResultsAt 1 year, 28 658 patient eyes underwent a mean of 6.4 anti-VEGF injections, gaining a mean of +4.2 letters (95% confidence interval for mean gain: +4.0 to +4.5 letters, p<0.001). When stratified by anti-VEGF medication and by years 2013–2018, no clinically meaningful differences in injection frequency or 1-year VA change resulted. At 1 year, 50% of eyes received ≤6 injections, while <20% received 10–13 injections, representing monthly treatment. Mean letters gained at 1 year generally showed a linear relationship with mean number of anti-VEGF injections, beyond two injections. Eyes with good baseline VA (≥20/40) generally were at risk of VA loss at 1 year; those with moderately severe baseline impairment (20/70 to 20/200) who received ≥10 injections improved by a mean of +10.3 letters.ConclusionIn clinical practice, patients with DMO undergo fewer anti-VEGF injections and exhibit worse visual gains compared with patients in randomised clinical trials. Visual outcomes correlate with treatment intensity at 1 year, with ceiling effects related to baseline VA.

Visual acuity outcomes and anti-VEGF therapy intensity in macular oedema due to retinal vein occlusion: a real-world analysis of 15 613 patient eyes

“…4 Similarly, a recent real-world study with corresponding eligibility criteria in 28 658 patient eyes with DME demonstrated a mean gain of 4.2 letters after a mean of 6.4 anti-VEGF injections in 1 year. 5 Nonetheless, while real-world patients with RVO-related ME show greater 1-year visual gains than real-world patients with nAMD and DME, they experience a larger gap in visual gain when compared with corresponding RCTs. In particular, for BRVO-related and CRVO-related ME, the aforementioned registration trials demonstrate an average 1-year BCVA improvement of 17.7 letters and 15.7 letters, respectively.…”

“…Analysis methods were similar to previous studies, which facilitated comparison of anti-VEGF treatment outcomes in RVOrelated ME with those previously described in other disease states using the same database. [2][3][4][5] Outcomes were analysed at the patient eye level, separately for branch retinal vein occlusion (BRVO)related ME and central retinal vein occlusion (CRVO)-related ME. As a sensitivity analysis, main outcome measures were assessed, excluding patients with RVO-related ME who underwent bilateral anti-VEGF treatment during the study period.…”

“…The database has been described in prior publications. [2][3][4][5] The Vestrum Health Retina Database holds de-identified visit data from approximately 1.5 million unique patients with over 11 million encounters. The panel of 350 US retina specialists are diversified geographically in the Southeast (24%), Mid-Atlantic (24%), West (20%), Southwest (12%), Northeast (8%), Great Lakes (7%) and North Central (4%) regions.…”

“…These outcomes in RVO-related ME were also compared with those previously described in neovascular age-related macular degeneration (nAMD) and diabetic macular oedema (DME), using the same database and similar analysis methodology. [2][3][4][5]…”

Managing Diabetic Macular Edema in Clinical Practice: Systematic Review and Meta-Analysis of Current Strategies and Treatment Options

“…Specifically, patients with DME experienced a mean 1-year BCVA gain of approximately +5 letters in a clinical setting, while in the DRCR.net Protocol T trial, vision improved by a mean of +13.3, +9.7 and +11.2 at 1 year for eyes treated with aflibercept, bevacizumab and ranibizumab, respectively. 9 , 19 , 80–82 …”