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One-year outcome of ranibizumab for neovascular age-related macular degeneration: A thorough analysis in a real-world clinical setting

机译:雷尼单抗治疗新生血管性年龄相关性黄斑变性的一年结果:在现实世界中的临床分析

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Purpose: To verify the safety and efficacy of ranibizumab in neovascular age-related macular degeneration (nAMD) and factors influencing the outcome in a real-world setting. Methods: Retrospective 12-month follow-up analysis of 100 naive nAMD eyes treated with as-needed ranibizumab. Changes in best-corrected visual acuity (BCVA), central retinal thickness (CRT), lesion, and leakage size were recorded. Type and characteristics of lesions and indicators of protocol adherence were analyzed. Results: Mean BCVA at baseline was 61.6 ± 14.8 Early Treatment Diabetic Retinopathy Study letters and 59.6 ± 16 at 12 months. Sixty-three eyes maintained or improved BCVA; the number of injections and follow-up visits were 4.8 and 5.1, respectively. First injection and pro re nata retreatments were administered 22.7 and 20.5 days after prescription, respectively. Seventy-two eyes received 3 initial monthly injections. Patients were not reinjected despite BCVA loss 5 letters one or more times in 37% of cases. No adverse events were reported. The CRT diminished by 26 ± 101 μm; choroidal neovascularization size and leakage area increased by 0.53 ± 1.31 mm2 and 0.34 ± 1.33 mm2, respectively. The BCVA gain was correlated with CRT reduction (ρ = 0.24, p = 0.016), mean baseline BCVA (ρ =-0.25, p = 0.01), age (ρ = -0.25, p = 0.01), and decrease in CNV size and leakage area (ρ= 0.56 and ρ = 0.59, respectively, p0.001). Conclusions: Our results compare unfavorably with those of controlled trials. Treatment and followup regimens in real-world settings seem to have a major role in determining outcome. Lower age and BCVA at baseline were associated with better response to treatment.
机译:目的:验证雷珠单抗在新生血管性年龄相关性黄斑变性(nAMD)中的安全性和有效性,以及在现实环境中影响预后的因素。方法:回顾性分析12个月的100例接受兰尼单抗单药治疗的幼稚nAMD眼睛。记录最佳矫正视力(BCVA),视网膜中央厚度(CRT),病变和渗漏大小的变化。分析了病变的类型和特征以及协议遵守的指标。结果:基线时的平均BCVA为61.6±14.8早期治疗糖尿病视网膜病变研究信,在12个月时为59.6±16。六十三只眼保持或改善了BCVA;注射次数和随访次数分别为4.8次和5.1次。处方后分别于22.7和20.5天进行首次注射和前列腺素再治疗。七十二只眼每月接受3次初始注射。尽管在37%的病例中BCVA丢失> 5个字母一次或多次,但仍未重新注射患者。没有不良反应的报道。 CRT减小了26±101μm;脉络膜新血管形成的大小和渗漏面积分别增加了0.53±1.31 mm2和0.34±1.33 mm2。 BCVA增益与CRT降低(ρ= 0.24,p = 0.016),平均基线BCVA(ρ= -0.25,p = 0.01),年龄(ρ= -0.25,p = 0.01)以及CNV大小的减少相关。泄漏面积(分别为ρ= 0.56和ρ= 0.59,p <0.001)。结论:我们的结果与对照试验相比不利。在现实世界中,治疗和随访方案似乎在决定结局方面起着重要作用。基线时较低的年龄和BCVA与对治疗的较好反应有关。

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