Kaufmann Gabriel T, Boucher Nicholas, Sharma Chakshu, Aggarwal Nitika, Starr Matthew R
Cole Eye Institute, Cleveland Clinic (G.T.K.), Cleveland, Ohio, USA.
Vestrum Health, LLC (N.B., C.S., N.A.), Naperville, Illinois, USA.
Am J Ophthalmol. 2025 Feb;270:172-182. doi: 10.1016/j.ajo.2024.10.017. Epub 2024 Oct 23.
To examine rates of submacular hemorrhage in patients undergoing anti-vascular endothelial growth factor (VEGF) injections, comparing rates between specific anti-VEGF agents.
Retrospective clinical cohort study.
All patients in the database from January 2015 to November 2023 with a diagnosis of neovascular age-related macular degeneration and accompanying submacular hemorrhage (SMH). SMH prevalence and associated anti-VEGF injection type were analyzed in 140,915 eyes (of which 9107 had SMH) in a nationwide aggregated electronic health care database using chi-square test of proportion. Visual acuity (VA) data was assessed using 2-sample independent t-tests. The primary outcome was rate of SMH per injection type. Secondary datapoints examined were time between SMH diagnosis and last anti-VEGF injection, number of injections before SMH, treatment interval at time of SMH, VA before and at 12 months after SMH, eyes undergoing pars plana vitrectomy (PPV) within 30 days of SMH, and VA before PPV and at 12 months after PPV.
The last injection type in eyes with SMH was bevacizumab in 3430 (37.8%) eyes, brolucizumab-dbll in 46 (0.51%) eyes, aflibercept in 3221 (35.4%) eyes. Ranibizumab in 2246 (24.7%) eyes, and faricimab-svoa in 155 (1.7%) eyes. Rates of SMH were significantly higher (P ≤ .001) for last injection with bevacizumab compared to every other injection type. Rates of SMH were significantly lower (P = .0004) for last injection with faricimab-svoa or ranibizumab injections each had significantly shorter (mean and standard deviation 48.9 (27.9), P < .02; mean and standard deviation 59.6 (38.2), P = .003, respectively) mean time between SMH diagnosis and last injection than did patients undergoing any other injection. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type among all patients. The number of patients who underwent PPV were 52 (1.51%) for bevacizumab, 4 (8.7%) for brolucizumab-dbll, 58 (1.8%) for aflibercept, 41 (1.8%) for ranibizumab, and 3 (1.9%) for faricimab-svoa. Mean VA before SMH and at 12 months after SMH did not significantly differ by injection type in patients undergoing PPV.
Faricimab may be more protective than other anti-VEGF injections against SMH in patients with neovascular age-related macular degeneration.
研究接受抗血管内皮生长因子（VEGF）注射的患者黄斑下出血的发生率，并比较特定抗VEGF药物之间的发生率。
回顾性临床队列研究。
数据库中2015年1月至2023年11月期间所有诊断为新生血管性年龄相关性黄斑变性并伴有黄斑下出血（SMH）的患者。在全国汇总的电子医疗数据库中，对140,915只眼（其中9107只眼有SMH）的SMH患病率和相关抗VEGF注射类型进行分析，采用比例卡方检验。使用两样本独立t检验评估视力（VA）数据。主要结局是每种注射类型的SMH发生率。检查的次要数据点包括SMH诊断与最后一次抗VEGF注射之间的时间、SMH发生前的注射次数、SMH发生时的治疗间隔、SMH发生前和发生后12个月的视力、SMH发生后30天内接受玻璃体切割术（PPV）的眼睛，以及PPV术前和术后12个月的视力。
发生SMH的眼中，最后一次注射的药物为贝伐单抗的有3430只眼（37.8%），布罗利尤单抗-dbll的有46只眼（0.51%），阿柏西普的有3221只眼（35.4%），雷珠单抗的有2246只眼（24.7%），法西单抗-svoa的有155只眼（1.7%）。与其他每种注射类型相比，最后一次注射贝伐单抗的SMH发生率显著更高（P≤0.001）。最后一次注射法西单抗-svoa或雷珠单抗的SMH发生率显著更低（P = 0.0004），与接受其他任何注射的患者相比，法西单抗-svoa和雷珠单抗注射的SMH诊断与最后一次注射之间的平均时间显著更短（平均值和标准差分别为48.9（27.9），P < 0.02；平均值和标准差为59.6（38.2），P = 0.003）。在所有患者中，不同注射类型的SMH发生前和发生后12个月的平均视力无显著差异。接受PPV的患者中，贝伐单抗组有52例（1.51%），布罗利尤单抗-dbll组有4例（8.7%），阿柏西普组有58例（1.8%），雷珠单抗组有41例（1.8%），法西单抗-svoa组有3例（1.9%）。接受PPV的患者中，不同注射类型的SMH发生前和发生后12个月的平均视力无显著差异。
在新生血管性年龄相关性黄斑变性患者中，法西单抗可能比其他抗VEGF注射剂对SMH具有更强的保护作用。
