Purpose

To report practice patterns of intravitreal injections of anti-VEGF for retinopathy of prematurity (ROP) and outcomes data with a focus on retreatments and complications.

Design

Multicenter, international, retrospective, consecutive series.

Subjects

Patients with ROP treated with anti-VEGF injections from 2007 to 2021.

Methods

Twenfty-three sites (16 United States [US] and 7 non-US) participated. Data collected included demographics, birth characteristics, examination findings, and methods of injections. Comparisons between US and non-US sites were made.

Main Outcome Measures

Primary outcomes included number and types of retreatments as well as complications. Secondary outcomes included specifics of the injection protocols, including types of medication, doses, distance from limbus, use of antibiotics, and quadrants where injections were delivered.

Results

A total of 1677 eyes of 918 patients (43% female, 57% male) were included. Mean gestational age was 25.7 weeks (range, 21.2–41.5 weeks), and mean birth weight was 787 g (range, 300–2700 g). Overall, a 30-gauge needle was most commonly used (51%), and the quadrant injected was most frequently the inferior-temporal (51.3%). The distance from the limbus ranged from 0.75 to 2 mm, with 1 mm being the most common (65%). Bevacizumab was the most common anti-VEGF (71.4%), with a dose of 0.625 mg in 64% of cases. Overall, 604 (36%) eyes required retreatment. Of those, 79.8% were retreated with laser alone, 10.6% with anti-VEGF injection alone, and 9.6% with combined laser and injection. Complications after anti-VEGF injections occurred in 15 (0.9%) eyes, and no cases of endophthalmitis were reported. Patients in the United States had lower birth weights and gestational ages (665.6 g and 24.5 weeks, respectively) compared with non-US patients (912.7 g and 26.9 weeks, respectively) (P < 0.0001). Retreatment with reinjection and laser was significantly more common in the US compared with the non-US group (8.5% vs. 4.7% [P = 0.0016] and 55% vs. 7.2% [P < 0.001], respectively). There was no difference in the incidence of complications between the 2 geographic subgroups.

Conclusions

Anti-VEGF injections for ROP were safe and well tolerated despite a variance in practice patterns. Infants with ROP receiving injections in the US tended to be younger and smaller, and they were treated earlier with more retreatments than non-US neonates with ROP.

中文翻译：

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玻璃体内注射抗 VEGF 治疗早产儿视网膜病变的实践模式和结果

目的

报告玻璃体内注射抗 VEGF 治疗早产儿视网膜病变(ROP) 的实践模式和结果数据，重点是再治疗和并发症。

设计

多中心、国际、回顾性、连续系列。

科目

2007 年至 2021 年接受抗 VEGF 注射治疗的 ROP 患者。

方法

23 个地点（16 个美国 [US] 和 7 个非美国）参与。收集的数据包括人口统计学、出生特征、检查结果和注射方法。对美国和非美国网站进行了比较。

主要观察指标

主要结果包括再治疗的次数和类型以及并发症。次要结果包括注射方案的细节，包括药物类型、剂量、与角膜缘的距离、抗生素的使用以及注射的象限。

结果

共纳入 918 名患者（43% 女性，57% 男性）的 1677 只眼。平均胎龄为 25.7 周（范围，21.2-41.5 周），平均出生体重为 787 克（范围，300-2700 克）。总体而言，最常用的是 30 号针头 (51%)，并且注射最频繁的象限是颞下 (51.3%)。距角膜缘的距离范围为 0.75 至 2 毫米，最常见的是 1 毫米 (65%)。贝伐单抗是最常见的抗 VEGF (71.4%)，在 64% 的病例中剂量为 0.625 mg。总体而言，604 (36%) 只眼睛需要再治疗。其中，79.8% 接受单独激光治疗，10.6% 接受单独抗 VEGF 注射治疗，9.6% 接受联合激光治疗和注射治疗。15 只眼 (0.9%) 发生抗 VEGF 注射后的并发症，无报告了眼内炎。美国患者的出生体重和胎龄（分别为 665.6 克和 24.5 周）低于非美国患者（分别为 912.7 克和 26.9 周）（P < 0.0001）。与非美国组相比，使用再注射和激光进行再治疗在美国更为常见（分别为 8.5% 对 4.7% [ P  = 0.0016] 和 55% 对 7.2% [ P < 0.001]）。2 个地理亚组之间的并发症发生率没有差异。

结论

尽管实践模式存在差异，但 ROP 的抗 VEGF 注射是安全且耐受性良好的。在美国接受注射的 ROP 婴儿往往更年轻、更小，并且与非美国 ROP 新生儿相比，他们更早接受更多的再治疗。