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Abstract：
BACKGROUND: Anti-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.
METHODS: A 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 (≤ 7% vs. > 7%) and GFR (> vs. ≤ 60 ml/min/m2 at 24 months were assessed.
RESULTS: The multivariate adjusted mean improvement in BCVA at 24 months of treatment was + 5.2 and + 6.8 letters in subgroups with baseline HbA1c level ≤ 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 m2, respectively (p = 0.852). The multivariate adjusted mean CST reduction was - 89.9 and - 76.4 µm in subgroups with baseline HbA1c level ≤ 7% and > 7%, respectively (p = 0.505), and - 85 and - 115 µm in subgroups with baseline GFR > 60 and ≤ 60 ml/min/1.73 m2, respectively (p = 0.130).
CONCLUSIONS: These 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.
Our 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.
METHODS: A 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 (≤ 7% vs. > 7%) and GFR (> vs. ≤ 60 ml/min/m2 at 24 months were assessed.
RESULTS: The multivariate adjusted mean improvement in BCVA at 24 months of treatment was + 5.2 and + 6.8 letters in subgroups with baseline HbA1c level ≤ 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 m2, respectively (p = 0.852). The multivariate adjusted mean CST reduction was - 89.9 and - 76.4 µm in subgroups with baseline HbA1c level ≤ 7% and > 7%, respectively (p = 0.505), and - 85 and - 115 µm in subgroups with baseline GFR > 60 and ≤ 60 ml/min/1.73 m2, respectively (p = 0.130).
CONCLUSIONS: These 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.
Our 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.
摘要：
背景：抗血管内皮生长因子（VEGF）治疗是糖尿病性黄斑水肿（DME）的一线治疗。我们调查了在常规临床实践中接受抗VEGF注射的DME患者的初始糖化血红蛋白（HbA1c）水平和肾小球滤过率（GFR）对治疗结果的影响。
方法：对来自前瞻性，多中心,观察性视网膜失明！进行登记。从2010年1月1日至2019年3月31日，共178只接受抗VEGF药物（雷珠单抗或阿柏西普）治疗的DME眼睛纳入分析。与长期的研究允许长达24个月的随访。眼睛的数据在抗击视网膜失明！注册表中进行了跟踪，使用本地软件收集临床参数。视力变化（最佳矫正视力[BCVA]，以字母表示)和解剖结果(中心子场厚度[CST]，根据基线HbA1c水平（≤7%vs.>7%)和GFR(>vs.在24个月时评估≤60ml/min/m2。
结果：在基线HbA1c水平≤7%和>7%的亚组中，治疗24个月时BCVA的多变量校正平均改善为+5.2和+6.8字母，分别(p=0.541)，GFR>60和<60ml/min/1.73m2的亚组分别为+6.9和+6.4个字母（p=0.852）。在基线HbA1c水平≤7%和>7%的亚组中，多变量校正平均CST降低为-89.9和-76.4µm，分别(p=0.505)，基线GFR>60和≤60ml/min/1.73m2的亚组分别为-85和-115µm（p=0.130）。
结论：这些结果似乎表明，接受玻璃体内VEGF抑制剂治疗DME的患者的视觉和解剖学改善与基线HbA1c水平和GFR无关，得出的结论是，在常规临床实践中，高HbA1c水平或低GFR不应决定注射时机。这项研究为眼科医生提供了有价值的见解，实现个性化治疗方法并优化DME患者预后。
我们的研究调查了糖化血红蛋白（HbA1c）和肾小球滤过率（GFR）的初始水平如何影响糖尿病性黄斑水肿（DME）的治疗结果。DME是以视网膜肿胀和视力问题为特征的糖尿病并发症。我们分析了DME患者的数据，这些患者接受了玻璃体内注射药物以减轻肿胀。我们的研究包括178只在常规临床实践中接受抗血管内皮生长因子（抗VEGF）注射的眼睛。结果表明，基线时的初始HbA1c水平和GFR对治疗24个月后DME患者的视觉和解剖学改善没有显着影响。提示HbA1c水平和肾功能不应成为确定常规临床实践中注射时机的主要因素.这些发现强调了个性化治疗方法的重要性，该方法考虑了HbA1c水平和肾功能以外的个体患者因素，以优化DME患者的预后。这些信息可以指导眼科医生对DME患者的注射时间和频率做出明智的决定。
方法：对来自前瞻性，多中心,观察性视网膜失明！进行登记。从2010年1月1日至2019年3月31日，共178只接受抗VEGF药物（雷珠单抗或阿柏西普）治疗的DME眼睛纳入分析。与长期的研究允许长达24个月的随访。眼睛的数据在抗击视网膜失明！注册表中进行了跟踪，使用本地软件收集临床参数。视力变化（最佳矫正视力[BCVA]，以字母表示)和解剖结果(中心子场厚度[CST]，根据基线HbA1c水平（≤7%vs.>7%)和GFR(>vs.在24个月时评估≤60ml/min/m2。
结果：在基线HbA1c水平≤7%和>7%的亚组中，治疗24个月时BCVA的多变量校正平均改善为+5.2和+6.8字母，分别(p=0.541)，GFR>60和<60ml/min/1.73m2的亚组分别为+6.9和+6.4个字母（p=0.852）。在基线HbA1c水平≤7%和>7%的亚组中，多变量校正平均CST降低为-89.9和-76.4µm，分别(p=0.505)，基线GFR>60和≤60ml/min/1.73m2的亚组分别为-85和-115µm（p=0.130）。
结论：这些结果似乎表明，接受玻璃体内VEGF抑制剂治疗DME的患者的视觉和解剖学改善与基线HbA1c水平和GFR无关，得出的结论是，在常规临床实践中，高HbA1c水平或低GFR不应决定注射时机。这项研究为眼科医生提供了有价值的见解，实现个性化治疗方法并优化DME患者预后。
我们的研究调查了糖化血红蛋白（HbA1c）和肾小球滤过率（GFR）的初始水平如何影响糖尿病性黄斑水肿（DME）的治疗结果。DME是以视网膜肿胀和视力问题为特征的糖尿病并发症。我们分析了DME患者的数据，这些患者接受了玻璃体内注射药物以减轻肿胀。我们的研究包括178只在常规临床实践中接受抗血管内皮生长因子（抗VEGF）注射的眼睛。结果表明，基线时的初始HbA1c水平和GFR对治疗24个月后DME患者的视觉和解剖学改善没有显着影响。提示HbA1c水平和肾功能不应成为确定常规临床实践中注射时机的主要因素.这些发现强调了个性化治疗方法的重要性，该方法考虑了HbA1c水平和肾功能以外的个体患者因素，以优化DME患者的预后。这些信息可以指导眼科医生对DME患者的注射时间和频率做出明智的决定。
