Abstract：
OBJECTIVE: This study aimed to report the visual and anatomical outcomes of intravitreal anti-VEGF treatment for diabetic macular edema (DME) in a real-world clinical setting from Turkey over 36 months.
METHODS: This is a retrospective, multicenter (7 sites) study. The medical records of 1072 eyes (both previously treated and naive eyes) of 706 consecutive patients with visual impairment due to center-involving DME treated with intravitreal anti-VEGF injections between April 2007 and February 2017 were reviewed. The eyes were divided into mutually exclusive three groups based on the duration of follow-up (12, 24, or 36 months). Primary outcome measures were changes in visual acuity (VA) and central macular thickness (CMT) from baseline to final visit in each cohort, frequency of visits and intravitreal anti-VEGF injections. As secondary endpoints, VA outcomes were assessed in subgroups stratified by baseline VA [<70 ETDRS letters and ≥70 ETDRS letters] and loading dose status of anti-VEGF injections.
RESULTS: VA increased by a mean of 8.2 letters (12-month cohort, p < 0.001), 5.3 letters (24-month cohort, p < 0.001), and 4.4 letters (36-month cohort, p = 0.017) at final visits. The eyes with <70 VA letters achieved more significant VA improvement at final visits in all cohorts compared with eyes with >70 VA letters (p < 0.001). The mean decreases in CMT from baseline to last visits at 12-, 24-, and 36- month cohorts were -100.5 µm, -107.7 µm, and -114.3 µm, respectively (p < 0.001). The mean number of injections given were 4.6, 2.3, and 1.8 during years 1 to 3, respectively. Patients who received loading dose showed greater VA gains than those who did not in all follow-up cohorts.
CONCLUSIONS: Our study revealed that anti-VEGF treatment improved VA and CMT over a follow-up of 36 months. Although these real-life VA outcomes following anti-VEGF therapy for DME were similar to other real-life studies, they were inferior to those noted in randomized controlled trials, mainly due to undertreatment.
METHODS: This is a retrospective, multicenter (7 sites) study. The medical records of 1072 eyes (both previously treated and naive eyes) of 706 consecutive patients with visual impairment due to center-involving DME treated with intravitreal anti-VEGF injections between April 2007 and February 2017 were reviewed. The eyes were divided into mutually exclusive three groups based on the duration of follow-up (12, 24, or 36 months). Primary outcome measures were changes in visual acuity (VA) and central macular thickness (CMT) from baseline to final visit in each cohort, frequency of visits and intravitreal anti-VEGF injections. As secondary endpoints, VA outcomes were assessed in subgroups stratified by baseline VA [<70 ETDRS letters and ≥70 ETDRS letters] and loading dose status of anti-VEGF injections.
RESULTS: VA increased by a mean of 8.2 letters (12-month cohort, p < 0.001), 5.3 letters (24-month cohort, p < 0.001), and 4.4 letters (36-month cohort, p = 0.017) at final visits. The eyes with <70 VA letters achieved more significant VA improvement at final visits in all cohorts compared with eyes with >70 VA letters (p < 0.001). The mean decreases in CMT from baseline to last visits at 12-, 24-, and 36- month cohorts were -100.5 µm, -107.7 µm, and -114.3 µm, respectively (p < 0.001). The mean number of injections given were 4.6, 2.3, and 1.8 during years 1 to 3, respectively. Patients who received loading dose showed greater VA gains than those who did not in all follow-up cohorts.
CONCLUSIONS: Our study revealed that anti-VEGF treatment improved VA and CMT over a follow-up of 36 months. Although these real-life VA outcomes following anti-VEGF therapy for DME were similar to other real-life studies, they were inferior to those noted in randomized controlled trials, mainly due to undertreatment.
摘要：
目的：本研究旨在报告在土耳其超过36个月的真实世界临床环境中，玻璃体内抗VEGF治疗糖尿病性黄斑水肿（DME）的视觉和解剖学结果。
方法：这是一个回顾性研究，多中心（7个站点）研究。回顾了2007年4月至2017年2月期间，由于涉及中心的DME接受玻璃体内抗VEGF注射治疗而出现视力障碍的706例连续患者的1072只眼（以前治疗过的和幼稚的眼睛）的医疗记录。根据随访时间（12、24或36个月），将眼睛分为互斥的三组。主要结局指标为每个队列中从基线到最终就诊的视力（VA）和中央黄斑厚度（CMT）的变化。就诊频率和玻璃体内注射抗VEGF。作为次要终点，通过基线VA[<70ETDRS字母和≥70ETDRS字母]和抗VEGF注射的负荷剂量状态对亚组的VA结果进行分层。
结果：VA平均增加8.2个字母（12个月队列，p<0.001)，5.3个字母（24个月队列，p<0.001)，和4.4个字母(36个月的队列，p=0.017）。与具有>70个VA字母的眼睛相比，在所有队列中，具有<70个VA字母的眼睛在最终就诊时实现了更显着的VA改善（p<0.001）。CMT从基线到最后一次就诊的平均下降时间为12-，24-,36个月的队列为-100.5µm，-107.7µm,和-114.3µm，分别(p<0.001)。在第1至3年期间，平均注射次数分别为4.6、2.3和1.8。在所有随访队列中，接受负荷剂量的患者比没有接受负荷剂量的患者显示出更大的VA增加。
结论：我们的研究表明，抗VEGF治疗在36个月的随访中改善了VA和CMT。尽管抗VEGF治疗DME后这些现实生活中的VA结果与其他现实生活中的研究相似，它们不如随机对照试验中提到的那些，主要是由于治疗不足。
方法：这是一个回顾性研究，多中心（7个站点）研究。回顾了2007年4月至2017年2月期间，由于涉及中心的DME接受玻璃体内抗VEGF注射治疗而出现视力障碍的706例连续患者的1072只眼（以前治疗过的和幼稚的眼睛）的医疗记录。根据随访时间（12、24或36个月），将眼睛分为互斥的三组。主要结局指标为每个队列中从基线到最终就诊的视力（VA）和中央黄斑厚度（CMT）的变化。就诊频率和玻璃体内注射抗VEGF。作为次要终点，通过基线VA[<70ETDRS字母和≥70ETDRS字母]和抗VEGF注射的负荷剂量状态对亚组的VA结果进行分层。
结果：VA平均增加8.2个字母（12个月队列，p<0.001)，5.3个字母（24个月队列，p<0.001)，和4.4个字母(36个月的队列，p=0.017）。与具有>70个VA字母的眼睛相比，在所有队列中，具有<70个VA字母的眼睛在最终就诊时实现了更显着的VA改善（p<0.001）。CMT从基线到最后一次就诊的平均下降时间为12-，24-,36个月的队列为-100.5µm，-107.7µm,和-114.3µm，分别(p<0.001)。在第1至3年期间，平均注射次数分别为4.6、2.3和1.8。在所有随访队列中，接受负荷剂量的患者比没有接受负荷剂量的患者显示出更大的VA增加。
结论：我们的研究表明，抗VEGF治疗在36个月的随访中改善了VA和CMT。尽管抗VEGF治疗DME后这些现实生活中的VA结果与其他现实生活中的研究相似，它们不如随机对照试验中提到的那些，主要是由于治疗不足。
