Department of Ophthalmology, Duke University Medical Center, Durham, North Carolina.
Jaeb Center for Health Research, Tampa, Florida.
Ophthalmology. 2022 Oct;129(10):1120-1128. doi: 10.1016/j.ophtha.2022.05.019. Epub 2022 Jun 1.
Low-dose and very low-dose intravitreal bevacizumab (IVB) have been reported to be successful in short-term treatment of type 1 retinopathy of prematurity (ROP), down to an initial dose of 0.004 mg. We now report 12-month outcomes for these infants.
Masked, multicenter, dose de-escalation study.
One hundred twenty prematurely born infants with type 1 ROP.
A cohort of 120 infants with type 1 ROP in at least 1 eye from 2 sequential dose de-escalation studies of low-dose IVB (0.25 mg, 0.125 mg, 0.063 mg, and 0.031 mg) or very low-dose IVB (0.016 mg, 0.008 mg, 0.004 mg, and 0.002 mg) to the study eye; the fellow eye (if also type 1) received 1 dose level higher of IVB. After primary success or failure at 4 weeks, clinical management was at investigator discretion, including all additional treatment.
Reactivation of severe ROP by 6 months corrected age, additional treatments, retinal and other ocular structural outcomes, and refractive error at 12 months corrected age.
Sixty-two of 113 study eyes (55%) and 55 of 98 fellow eyes (56%) received additional treatment. Of the study eyes, 31 (27%) received additional ROP treatment, and 31 (27%) received prophylactic laser therapy for persistent avascular retina. No trend toward a higher risk of additional ROP treatment related to initial IVB doses was found. However, time to reactivation among study eyes was shorter in eyes that received very low-dose IVB (mean, 76.4 days) than in those that received low-dose IVB (mean, 85.7 days). At 12 months, poor retinal outcomes and anterior segment abnormalities both were uncommon (3% and 5%, respectively), optic atrophy was noted in 10%, median refraction was mildly myopic (-0.31 diopter), and strabismus was present in 29% of infants.
Retinal structural outcomes were very good after low- and very low-dose IVB as initial treatment for type 1 ROP, although many eyes received additional treatment. The rate of reactivation of severe ROP was not associated with dose; however, a post hoc data-driven analysis suggested that reactivation was sooner with very low doses.
低剂量和超低剂量玻璃体内注射贝伐单抗（IVB）已被报道在治疗 1 型早产儿视网膜病变（ROP）方面取得了短期成功，初始剂量低至 0.004mg。我们现在报告这些婴儿的 12 个月结果。
盲法、多中心、剂量递减研究。
120 名早产儿患有 1 型 ROP。
对来自 2 项低剂量 IVB（0.25mg、0.125mg、0.063mg 和 0.031mg）或超低剂量 IVB（0.016mg、0.008mg、0.004mg 和 0.002mg）的 1 型 ROP 进行了 120 例连续剂量递减研究的 1 只眼的队列；对侧眼（如果也为 1 型）接受了 1 个较高剂量水平的 IVB。在 4 周时原发性成功或失败后，临床管理由研究者自行决定，包括所有其他治疗。
6 个月矫正年龄时严重 ROP 的再激活、其他治疗、视网膜和其他眼部结构结果以及 12 个月矫正年龄时的屈光不正。
113 只研究眼中有 62 只（55%）和 98 只对侧眼中有 55 只（56%）接受了额外治疗。在研究眼中，31 只（27%）接受了额外的 ROP 治疗，31 只（27%）接受了预防性激光治疗以保持无血管视网膜。没有发现初始 IVB 剂量与额外 ROP 治疗风险增加之间的趋势。然而，接受超低剂量 IVB 的研究眼的再激活时间较短（平均 76.4 天），而接受低剂量 IVB 的研究眼再激活时间较长（平均 85.7 天）。在 12 个月时，视网膜结果和前段异常均不常见（分别为 3%和 5%），10%的眼出现视神经萎缩，中位数屈光度为轻度近视（-0.31 屈光度），29%的婴儿存在斜视。
作为 1 型 ROP 的初始治疗，低剂量和超低剂量 IVB 的视网膜结构结果非常好，尽管许多眼接受了额外的治疗。严重 ROP 再激活的发生率与剂量无关；然而，事后数据驱动分析表明，低剂量时再激活更快。
