A Prospective Randomized Trial of Intravitreal Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema (BOLT Study) 12-Month Data: Report 2
A Prospective Randomized Trial of Intravitreal Bevacizumab or Laser Therapy in the Management of Diabetic Macular Edema (BOLT Study) 12-Month Data: Report 2
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DOI：
10.1016/j.ophtha.2010.03.045
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发表时间：
2010-06-01
期刊：
影响因子：
13.7
通讯作者：
Hykin, Philip G.
中科院分区：
文献类型：
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作者：
Michaelides, Michel;Kaines, Andrew;Hykin, Philip G.
目的：报道一项比较反复玻璃体内注射贝伐单抗(IVB)和改良早期糖尿病视网膜病变研究(ETDRS)黄斑激光疗法(MLT)治疗持续性临床显著糖尿病黄斑水肿(CSME)患者1年的研究结果。设计：前瞻性、随机、隐蔽、单中心、2年、2臂临床试验。参与者：80例80只眼受累于CSME患者和至少1例既往MLT。方法：受试者随机分为IVB组(每周6次；前12个月最少注射3次，最多注射9次)或MLT(4个月；主要观察指标：主要终点是12个月时贝伐单抗组和激光组的ETDRS最佳矫正视力(BCVA)的差异。结果：贝伐单抗组和激光组的基线ETDRS最佳矫正视力分别为55.7+/-9.7(34-69)和54.6+/-8.6(36-68)。12个月时，贝伐单抗组平均ETDRBCVA为61.34+/-10.4(34-79)，激光组为50.0+/-16.6(8-76)(P=0.0006)。此外，贝伐单抗组获得了8个ETDRS字母的中位数，而激光组丢失了0.5ETDRS字母(P=0.0002)。贝伐单抗组在12个月内获得10个ETDRS字母的几率是激光组的5.1倍(调整后的优势比为5.1；95%可信区间为1.3-19.7；P=0.019)。12个月时，黄斑中心厚度由基线时的507+/-145微米(281-900微米)减至378+/-134微米(167-699微米)(P
Purpose: To report the findings at 1 year of a study comparing repeated intravitreal bevacizumab (ivB) and modified Early Treatment of Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant diabetic macular edema (CSME).Design: Prospective, randomized, masked, single-center, 2-year, 2-arm clinical trial.Participants: A total of 80 eyes of 80 patients with center-involving CSME and at least 1 prior MLT.Methods: Subjects were randomized to either ivB (6 weekly; minimum of 3 injections and maximum of 9 injections in the first 12 months) or MLT (4 monthly; minimum of 1 treatment and maximum of 4 treatments in the first 12 months).Main Outcome Measures: The primary end point was the difference in ETDRS best-corrected visual acuity (BCVA) at 12 months between the bevacizumab and laser arms.Results: The baseline mean ETDRS BCVA was 55.7 +/- 9.7 (range 34-69) in the bevacizumab group and 54.6 +/- 8.6 (range 36-68) in the laser arm. The mean ETDRS BCVA at 12 months was 61.3 +/- 10.4 (range 34-79) in the bevacizumab group and 50.0 +/- 16.6 (range 8-76) in the laser arm (P = 0.0006). Furthermore, the bevacizumab group gained a median of 8 ETDRS letters, whereas the laser group lost a median of 0.5 ETDRS letters (P = 0.0002). The odds of gaining >= 10 ETDRS letters over 12 months were 5.1 times greater in the bevacizumab group than in the laser group (adjusted odds ratio, 5.1; 95% confidence interval, 1.3-19.7; P = 0.019). At 12 months, central macular thickness decreased from 507 +/- 145 mu m (range 281-900 mu m) at baseline to 378 +/- 134 mu m (range 167-699 mu m) (P