Johns Hopkins University School of Medicine, Baltimore, Maryland.
Editor, JAMA Ophthalmology.
JAMA Ophthalmol. 2024 Aug 1;142(8):772-776. doi: 10.1001/jamaophthalmol.2024.2061.
Intraocular pressure (IOP) elevations of clinical relevance have been observed after the commonly used 0.05-mL volume for intravitreous injections. However, more recently approved intravitreous agents involve volumes from 0.07 to 0.1 mL. It is not well established whether repeated 0.1-mL intravitreous injections may result in IOP-related complications.
To investigate the effect of 1 year of repeated 0.1-mL intravitreous injections on IOP outcomes.
DESIGN, SETTING, AND PARTICIPANTS: This study was a post hoc analysis of 2 clinical trials investigating the IOP safety of intravitreous lampalizumab on geographic atrophy secondary to age-related macular degeneration. Both trials were conducted between 2014 and 2018 and recruited participants who were 50 years or older and had bilateral geographic atrophy. This post hoc analysis was performed between 2018 and 2022.
Intravitreous lampalizumab, 0.1 mL, every 4 weeks; lampalizumab, 0.1 mL, every 6 weeks; or sham procedure every 4 weeks or 6 weeks for 48 weeks.
IOP changes in the 4-week-frequency study arms and ocular adverse events to week 48 in all arms. The hypothesis for this analysis was formulated after data collection.
Among a total of 1851 participants, there was no change in mean pre-injection IOP values through 48 weeks in either arm. The adverse events glaucoma and ocular hypertension were reported for 1.8% of participants treated with lampalizumab and 1.6% of those in the sham arm.
Over 1 year, IOP increases were rare and did not affect treated participants more frequently than sham arm participants. These findings support the low risk of persistent IOP increases, on average, of intravitreous 0.1-mL injection volumes administered for 1 year in a manner similar to that performed in these clinical trials. These results may be valuable in the design of future therapeutic trials considering this volume for injections particularly as more recently approved agents use volumes of 0.07 to 0.1 mL.
ClinicalTrials.gov Identifiers: NCT02247479 and NCT02247531.
在常用的 0.05 毫升体积进行玻璃体腔内注射后，观察到具有临床相关性的眼内压升高。然而，最近批准的玻璃体腔内药物涉及 0.07 至 0.1 毫升的体积。目前尚不清楚重复 0.1 毫升玻璃体腔内注射是否会导致与眼压相关的并发症。
研究 1 年重复 0.1 毫升玻璃体腔内注射对眼压结果的影响。
设计、地点和参与者：本研究是对 2 项临床试验的事后分析，该研究调查了玻璃体腔内 lampalizumab 治疗与年龄相关性黄斑变性相关的地图状萎缩的眼压安全性。这两项试验均于 2014 年至 2018 年进行，招募了年龄在 50 岁或以上且双侧地图状萎缩的参与者。这项事后分析于 2018 年至 2022 年进行。
玻璃体腔内 lampalizumab，0.1 毫升，每 4 周；lampalizumab，0.1 毫升，每 6 周；或 sham 程序，每 4 周或 6 周，共 48 周。
4 周频率研究臂的眼压变化和所有臂的第 48 周眼部不良事件。本分析的假设是在数据收集后制定的。
在总共 1851 名参与者中，无论是在哪个治疗臂，在 48 周内，平均预注射眼压值均无变化。接受 lampalizumab 治疗的参与者中有 1.8%和 sham 臂参与者中有 1.6%报告了青光眼和眼压升高这两种眼部不良事件。
在 1 年以上的时间里，眼压升高很少见，且在接受治疗的参与者中并不比 sham 臂参与者更频繁地发生。这些发现支持在这些临床试验中以类似方式给药 1 年的玻璃体腔内 0.1 毫升注射体积平均眼压升高风险低。这些结果在设计考虑该体积注射的未来治疗试验时可能具有重要意义，特别是因为最近批准的药物使用 0.07 至 0.1 毫升的体积。
ClinicalTrials.gov 标识符：NCT02247479 和 NCT02247531。
