Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity.
Efficacy of intravitreal bevacizumab for stage 3+ retinopathy of prematurity.
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DOI：
10.1056/nejmoa1007374
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发表时间：
2011-02-17
期刊：
影响因子：
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通讯作者：
BEAT-ROP Cooperative Group
中科院分区：
文献类型：
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作者：
Mintz-Hittner HA;Kennedy KA;Chuang AZ;BEAT-ROP Cooperative Group
早产儿视网膜病变是全世界儿童失明的主要原因。常规(融合式)激光周边视网膜切除术是破坏性的，会导致并发症，而且不能防止所有视力丧失，特别是在早产儿视网膜病变影响到眼睛的I区的情况下。接受血管内皮生长因子抑制剂治疗的患者的病例系列表明，这些药物可能对治疗早产儿视网膜病变有用。我们进行了一项前瞻性、对照、随机、分层的多中心试验，以评估玻璃体腔内贝伐单抗治疗早产儿后3+区(即3期)早产儿视网膜病变的疗效。婴儿被随机分配到玻璃体内接受贝伐单抗(0.625毫克在0.025毫升溶液中)或常规激光治疗，双侧。主要的眼部结果是在月经后54周之前需要再次治疗的一只或双眼早产儿视网膜病变复发。我们招募了150名婴儿(总样本300只眼)；143名婴儿存活到54周后，7名死亡的婴儿不包括在主要结局分析中。贝伐单抗组有4例(4%)早产儿视网膜病变复发，激光治疗组有19例(32眼)复发，P=0.002。对早产儿I区视网膜病变有显著疗效(P=0.003.0 5)，对II区视网膜病变无明显疗效(P=0.2 7)。与传统激光治疗相比，玻璃体腔内贝伐单抗治疗早产儿3+期视网膜病变对I区视网膜病变有显著疗效，但对II区视网膜病变无明显益处。玻璃体内注射贝伐单抗后，周边视网膜血管继续发育，但常规激光治疗会导致周边视网膜的永久性破坏。这项试验规模太小，无法评估安全性。
Retinopathy of prematurity is a leading cause of childhood blindness worldwide. Peripheral retinal ablation with conventional (confluent) laser therapy is destructive, causes complications, and does not prevent all vision loss, especially in cases of retinopathy of prematurity affecting zone I of the eye. Case series in which patients were treated with vascular endothelial growth factor inhibitors suggest that these agents may be useful in treating retinopathy of prematurity. We conducted a prospective, controlled, randomized, stratified, multicenter trial to assess intravitreal bevacizumab monotherapy for zone I or zone II posterior stage 3+ (i.e., stage 3 with plus disease) retinopathy of prematurity. Infants were randomly assigned to receive intravitreal bevacizumab (0.625 mg in 0.025 ml of solution) or conventional laser therapy, bilaterally. The primary ocular outcome was recurrence of retinopathy of prematurity in one or both eyes requiring retreatment before 54 weeks’ postmenstrual age. We enrolled 150 infants (total sample of 300 eyes); 143 infants survived to 54 weeks’ postmenstrual age, and the 7 infants who died were not included in the primary-outcome analyses. Retinopathy of prematurity recurred in 4 infants in the bevacizumab group (6 of 140 eyes [4%]) and 19 infants in the laser-therapy group (32 of 146 eyes [22%], P = 0.002). A significant treatment effect was found for zone I retinopathy of prematurity (P = 0.003) but not for zone II disease (P = 0.27). Intravitreal bevacizumab monotherapy, as compared with conventional laser therapy, in infants with stage 3+ retinopathy of prematurity showed a significant benefit for zone I but not zone II disease. Development of peripheral retinal vessels continued after treatment with intravitreal bevacizumab, but conventional laser therapy led to permanent destruction of the peripheral retina. This trial was too small to assess safety.