Retinal Diagnostic Center, Campbell, California.
JAMA Ophthalmol. 2023 Nov 1;141(11):1062-1065. doi: 10.1001/jamaophthalmol.2023.4326.
Recently, intravitreal pegcetacoplan became the first drug to gain US Food and Drug Administration approval for the treatment of geographic atrophy associated with nonexudative age-related macular degeneration, but the administration of this medication may be associated with unanticipated posttreatment complications.
To assess the prevalence of presumed silicone oil droplets in the vitreous cavity after intravitreal injection of pegcetacoplan.
DESIGN, SETTING, AND PARTICIPANTS: This case series study involved a retrospective record review of all 55 patients treated with intravitreal pegcetacoplan, 0.1 mL in 150-mg/mL solution, between March 24 and June 5, 2023, at a single specialty retina practice. All injections were done using needles from the kit supplied by Apellis Pharmaceuticals on a 1-mL McKesson Luer lock syringe.
The presence or absence of presumed silicone bubbles detected during dilated biomicroscopic fundus examination and/or on color fundus photographs, the presence or absence of symptoms, change in visual acuity, and/or increase in intraocular pressure.
A total of 62 intravitreal pegcetacoplan injections were given to 55 patients (mean [SD] age, 83.8 [7.8] years; 33 women [60%]) from March 24 to June 5, 2023. Of the 55 patients, 16 (29%; mean [SD] age, 83.8 [7.4] years; 9 women [56%]) had presumed intravitreal silicone droplets discovered 2 to 4 weeks after treatment, 3 of which were documented on color fundus photographs. Of the 16 patients, 14 (88%) were symptomatic for new floaters that they described as persistent, while 2 (13%) were asymptomatic. There were no signs of inflammation or infection, no increases in intraocular pressure, and no changes in visual acuity for all 16 patients.
A substantial percentage of patients had symptomatic floaters from presumed intravitreal silicone oil droplets after injections of pegcetacoplan using a McKesson 1-mL Luer lock syringe. These findings support consideration of informing patients of this potential adverse effect, avoiding use of the McKesson syringe, and considering use of silicone-free syringes for pegcetacoplan injections.
最近，玻璃体腔内注射培戈西他滨成为首个获得美国食品和药物管理局批准用于治疗非渗出性年龄相关性黄斑变性相关地理萎缩的药物，但这种药物的使用可能与治疗后出现的意外并发症有关。
评估培戈西他滨玻璃体腔内注射后玻璃体腔中疑似硅油滴的发生率。
设计、设置和参与者：这项病例系列研究回顾性分析了 2023 年 3 月 24 日至 6 月 5 日期间，在一家专业的视网膜科诊所，对 55 例接受培戈西他滨（150mg/ml 溶液，0.1ml）玻璃体腔内注射的患者进行了记录。所有注射均使用 Apellis 制药公司试剂盒中的针头，通过 McKesson Luer 锁注射器 1ml 进行。
通过散瞳后生物显微镜眼底检查和/或彩色眼底照片检查发现的疑似硅油气泡的存在或不存在、症状、视力变化和/或眼压升高的存在或不存在。
2023 年 3 月 24 日至 6 月 5 日，对 55 例（平均[标准差]年龄 83.8[7.8]岁；33 例女性[60%]）患者共进行了 62 次培戈西他滨玻璃体腔内注射。在 55 例患者中，16 例（29%；平均[标准差]年龄 83.8[7.4]岁；9 例女性[56%]）在治疗后 2 至 4 周发现疑似玻璃体硅油滴，其中 3 例有彩色眼底照片记录。在 16 例患者中，14 例（88%）出现新的漂浮物症状，他们描述为持续存在，而 2 例（13%）无症状。所有 16 例患者均无炎症或感染迹象，眼压无升高，视力无变化。
使用 McKesson 1ml Luer 锁注射器进行培戈西他滨玻璃体注射后，相当一部分患者出现了疑似玻璃体硅油滴导致的有症状的漂浮物。这些发现支持向患者告知这种潜在的不良反应，避免使用 McKesson 注射器，并考虑使用不含硅的注射器进行培戈西他滨注射。
