Does HbA1c Level or Glomerular Filtration Rate Affect the Clinical Response to Endothelial Growth Factor Therapy (Ranibizumab or Aflibercept) in Diabetic Macular Edema? A Real-Life Experience

IntroductionAnti-vascular endothelial growth factor (VEGF) therapy is the first-line treatment for diabetic macular edema (DME). We investigated the effect of initial glycosylated hemoglobin (HbA1c) level and glomerular filtration rate (GFR) on treatment outcomes in patients with DME receiving anti-VEGF injections in routine clinical practice.MethodsA retrospective analysis of data from the prospective, multi-center, observational Fight Retinal Blindness! registry was performed. A total of 178 eyes with DME treated with anti-VEGF agents (ranibizumab or aflibercept) from 1 January 2010 to 31 March 2019 were enrolled in the analysis, with the long study period to allow for up to 24 months of follow-up. Data for eyes were tracked in the Fight Retinal Blindness! registry, and clinical parameters were collected by using local software. Changes in visual (best-corrected visual acuity [BCVA], in letters) and anatomic outcomes (central subfield thickness [CST], in microns) between subgroups of patients according to baseline HbA1c level (& LE; 7% vs. > 7%) and GFR (> vs. & LE; 60 ml/min/m(2) at 24 months were assessed.ResultsThe multivariate adjusted mean improvement in BCVA at 24 months of treatment was + 5.2 and + 6.8 letters in subgroups with baseline HbA1c level & LE; 7% and > 7%, respectively (p = 0.541), and + 6.9 and + 6.4 letters in subgroups with GFR > 60 and < 60 ml/min/1.73 m(2), respectively (p = 0.852). The multivariate adjusted mean CST reduction was - 89.9 and - 76.4 & mu;m in subgroups with baseline HbA1c level & LE; 7% and > 7%, respectively (p = 0.505), and - 85 and - 115 & mu;m in subgroups with baseline GFR > 60 and & LE; 60 ml/min/1.73 m(2), respectively (p = 0.130).ConclusionThese results seem to indicate that visual and anatomical improvement in patients receiving intravitreal VEGF inhibitors for DME are independent of baseline HbA1c level and GFR, leading to the conclusion that high HbA1c levels or low GFR should not dictate injection timing in routine clinical practice. This study offers valuable insights for ophthalmologists, enabling a personalized treatment approach and optimizing DME patient outcomes. Plain Language SummaryOur study investigated how initial levels of glycosylated hemoglobin (HbA1c) and glomerular filtration rate (GFR) influence the treatment outcomes of diabetic macular edema (DME). DME is a complication of diabetes characterized by retinal swelling and vision problems. We analyzed data from a registry of DME patients who received intravitreal injections of medication to reduce swelling. Our study included 178 eyes receiving anti-vascular endothelial growth factor (anti-VEGF) injections in routine clinical practice. The results indicated that the initial HbA1c levels and GFR at baseline did not demonstrate a significant influence on the visual and anatomical improvements observed in patients with DME after 24 months of treatment, suggesting that HbA1c levels and kidney function should not be the primary factors taken into consideration in determining the timing of injections in routine clinical practice. These findings emphasize the importance of a personalized treatment approach that considers individual patient factors beyond HbA1c levels and kidney function to optimize outcomes for DME patients. This information can guide ophthalmologists in making informed decisions on the timing and frequency of injections for their patients with DME.