Department of Ophthalmology, Stanford University School of Medicine, California Pacific Medical Center, Stanford, California, USA.
Ophthalmology. 2011 Dec;118(12):2447-52. doi: 10.1016/j.ophtha.2011.05.026. Epub 2011 Aug 27.
To explore the association between treatment for neovascular age-related macular degeneration (AMD) and incidence and timing of retinal pigment epithelium (RPE) tears in ranibizumab-treated patients versus control treatment.
Results from 3 phase III clinical trials (ANti-VEGF antibody for the treatment of predominantly classic CHORoidal neovascularization in age-related macular degeneration [ANCHOR], Minimally classic/occult trial of the Anti-VEGF antibody Ranibizumab In the treatment of Neovascular Age-related macular degeneration [MARINA], and A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovascularization [CNV] with or without Classic CNV Secondary to Age-Related Macular Degeneration [PIER]) were retrospectively reviewed to identify patients who developed RPE tears during the study period, detected on fluorescein angiography performed at prespecified intervals.
Patients with baseline and post-baseline angiographic assessments.
Patients received intravitreal ranibizumab (0.3 or 0.5 mg) or control treatment (verteporfin photodynamic therapy [PDT] in ANCHOR and sham intravitreal injections in ANCHOR, MARINA, and PIER).
Incidence and timing of RPE tears during the treatment period.
Data from 1298 patients were analyzed. No statistically significant differences in RPE tear incidence were observed. The pooled rate of RPE tears was 1.8% with 0.5 mg ranibizumab, 3.0% with 0.3 mg ranibizumab, and 1.6% in the control group. Most (76%; 16/21) RPE tears in ranibizumab-treated patients were identified within 3 months of initiating treatment, whereas the majority (80%; 4/5) of late-onset RPE tears occurred in control patients. In patients who developed RPE tears, better visual acuity (VA) outcomes were observed in those treated with ranibizumab versus control treatment.
As studied in these trials, no statistically significant differences in the incidence of RPE tears within a 2-year treatment period were observed in patients who received ranibizumab (0.5 or 0.3 mg) versus control treatment, although most RPE tears with ranibizumab occurred within 3 months of initiating treatment. Mean VA was better in patients who developed RPE tears while receiving ranibizumab than in those who received control treatment, suggesting a potential benefit of continued ranibizumab therapy in patients with neovascular AMD who developed RPE tears.
FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found after the references.
探讨雷珠单抗治疗与对照治疗组新生血管性年龄相关性黄斑变性（AMD）患者中 RPE 撕裂的发生率和发生时间之间的关系。
回顾性分析了 3 项 III 期临床试验（治疗年龄相关性黄斑变性中主要为典型脉络膜新生血管的抗血管内皮生长因子抗体[ANCHOR]、雷珠单抗治疗新生血管性年龄相关性黄斑变性的最小典型/隐匿试验[MARINA]和 IIIb 期、多中心、随机、双盲、假注射对照研究雷珠单抗治疗伴有或不伴有年龄相关性黄斑变性继发典型脉络膜新生血管的黄斑下脉络膜新生血管的疗效和安全性[CNV]）的结果，以确定研究期间发生 RPE 撕裂的患者，并在预定间隔进行荧光素血管造影检查。
具有基线和基线后血管造影评估的患者。
患者接受玻璃体腔内雷珠单抗（0.3 或 0.5 mg）或对照治疗（在 ANCHOR 中采用维替泊芬光动力疗法[PDT]，在 ANCHOR、MARINA 和 PIER 中采用玻璃体腔内假注射）。
治疗期间 RPE 撕裂的发生率和发生时间。
对 1298 例患者的数据进行了分析。未观察到 RPE 撕裂发生率的统计学显著差异。雷珠单抗治疗组 RPE 撕裂的累积发生率为 1.8%（0.5 mg 雷珠单抗）、3.0%（0.3 mg 雷珠单抗）和对照组 1.6%。雷珠单抗治疗组的大多数（76%，16/21）RPE 撕裂发生在治疗开始后 3 个月内，而对照组的大多数（80%，4/5）迟发性 RPE 撕裂发生在对照组。在发生 RPE 撕裂的患者中，与接受对照治疗的患者相比，接受雷珠单抗治疗的患者视力（VA）结局更好。
在这些试验中，与接受对照治疗的患者相比，接受雷珠单抗（0.5 或 0.3 mg）治疗的患者在 2 年治疗期间 RPE 撕裂的发生率没有统计学显著差异，尽管大多数 RPE 撕裂发生在治疗开始后 3 个月内。与接受对照治疗的患者相比，发生 RPE 撕裂但接受雷珠单抗治疗的患者的平均 VA 更好，这表明对于发生 RPE 撕裂的新生血管性 AMD 患者，继续接受雷珠单抗治疗可能有潜在益处。
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