一项为期2年的玻璃体腔内注射贝伐单抗或激光治疗（BOLT）糖尿病性黄斑水肿的前瞻性随机对照试验：24个月数据：报告3

A 2-year prospective randomized controlled trial of intravitreal bevacizumab or laser therapy (BOLT) in the management of diabetic macular edema: 24-month data: report 3.

作者信息

Rajendram Ranjan, Fraser-Bell Samantha, Kaines Andrew, Michaelides Michel, Hamilton Robin D, Esposti Simona Degli, Peto Tunde, Egan Catherine, Bunce Catey, Leslie Richard David, Hykin Philip G

机构信息

Department of Medical Retina, Moorfields Eye Hospital, 162 City Rd, London EC1V 2PD, England, UK.

出版信息

Arch Ophthalmol. 2012 Aug;130(8):972-9. doi: 10.1001/archophthalmol.2012.393.

DOI:10.1001/archophthalmol.2012.393

PMID:22491395

Abstract

OBJECTIVE

To report the 2-year outcomes of the BOLT study, a prospective randomized controlled trial evaluating intravitreous bevacizumab and modified Early Treatment Diabetic Retinopathy Study (ETDRS) macular laser therapy (MLT) in patients with persistent clinically significant macular edema (CSME).

METHODS

In a 2-year, single-center, randomized controlled trial, 80 patients with center-involving CSME and visual acuity of 20/40 to 20/320 were randomized to receive either bevacizumab or MLT.

PRIMARY OUTCOME

difference in ETDRS best-corrected visual acuity (BCVA) between arms.

SECONDARY OUTCOMES

mean change in BCVA, proportion gaining at least 15 and at least 10 ETDRS letters, losing fewer than 15 and at least 30 letters, change in central macular thickness, ETDRS retinopathy severity, and safety outcomes.

RESULTS

At 2 years, mean (SD) ETDRS BCVA was 64.4 (13.3) (ETDRS equivalent Snellen fraction: 20/50) in the bevacizumab arm and 54.8 (12.6) (20/80) in the MLT arm (P=.005). The bevacizumab arm gained a median of 9 ETDRS letters vs 2.5 letters for MLT (P=.005), with a mean gain of 8.6 letters for bevacizumab vs amean loss of 0.5 letters for MLT. Forty-nine percent of patients gained 10 or more letters (P=.001) and 32% gained at least 15 letters (P=.004) for bevacizumab vs 7% and 4% for MLT. Percentage who lost fewer than 15 letters in the MLT arm was 86% vs 100% for bevacizumab (P=.03). Mean reduction in central macular thickness was 146 μm in the bevacizumab arm vs 118 μm in the MLT arm. The median number of treatments over 24 months was 13 for bevacizumab and 4 for MLT.

CONCLUSIONS

This study provides evidence supporting longer-term use of intravitreous bevacizumab for persistent center-involving CSME.

APPLICATION TO CLINICAL PRACTICE

Improvements in BCVA and central macular thickness seen with bevacizumab at 1 year were maintained over the second year with a mean of 4 injections.

TRIAL REGISTRATION

eudract.ema.europa.eu Identifier: 2007-000847-89

摘要

目的

报告BOLT研究的2年结果，这是一项前瞻性随机对照试验，评估玻璃体内注射贝伐单抗和改良早期糖尿病性视网膜病变研究（ETDRS）黄斑激光治疗（MLT）对持续性临床显著性黄斑水肿（CSME）患者的疗效。

方法

在一项为期2年的单中心随机对照试验中，80例累及黄斑中心凹的CSME患者，视力在20/40至20/320之间，被随机分为接受贝伐单抗或MLT治疗。

主要结局

两组间ETDRS最佳矫正视力（BCVA）的差异。

次要结局

BCVA的平均变化、至少提高15个和至少10个ETDRS字母的患者比例、视力下降少于15个和至少30个字母的患者比例、中心黄斑厚度的变化、视网膜病变严重程度以及安全性结局。

结果

2年后，贝伐单抗组的平均（标准差）ETDRS BCVA为64.4（13.3）（ETDRS等效Snellen视力分数：20/50），MLT组为54.8（12.6）（20/80）（P = 0.005）。贝伐单抗组ETDRS字母数中位数增加9个，而MLT组增加2.5个（P = 0.005），贝伐单抗组平均增加8.6个字母，而MLT组平均下降0.5个字母。贝伐单抗组49%的患者视力提高10个或更多字母（P = 0.001），32%的患者至少提高15个字母（P = 0.004），而MLT组分别为7%和4%。MLT组视力下降少于15个字母的患者比例为86%，而贝伐单抗组为100%（P = 0.03）。贝伐单抗组中心黄斑厚度平均减少146μm，MLT组减少118μm。24个月内贝伐单抗治疗的中位数为13次，MLT为4次。