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首页> 外文期刊>Eye >A randomised prospective double-masked exploratory study comparing combination photodynamic treatment and intravitreal ranibizumab vs intravitreal ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration.
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A randomised prospective double-masked exploratory study comparing combination photodynamic treatment and intravitreal ranibizumab vs intravitreal ranibizumab monotherapy in the treatment of neovascular age-related macular degeneration.

机译：比较光动力疗法与玻璃体内雷珠单抗与玻璃体内雷珠单抗单药联合治疗新血管性年龄相关性黄斑变性的随机前瞻性双盲探索性研究。

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AIMS: The aim of this study is to evaluate the effect of standard-fluence verteporfin photodynamic therapy (PDT) delivered on the first day of a ranibizumab regimen for choroidal neovascularisation secondary to age-related macular degeneration compared with ranibizumab monotherapy. METHODS: Patients were randomised to sham or standard-fluence verteporfin PDT at baseline. The first of three monthly loading doses of ranibizumab was given on the same day, and thereafter patients received monthly treatment with ranibizumab as required. All patients underwent monthly visual acuity and OCT assessment and 3-monthly fluorescein angiography with follow-up to 1 year. RESULTS: In all, 18 patients were recruited. The PDT group gained a mean of 2.2 ETDRS letters at 1 year and the sham group gained a mean of 4.4 letters (P=0.47). Both groups required a mean of 1.3 injections of ranibizumab following the 3-month loading phase. Fluorescein angiography at 1 month demonstrated marked choroidal hypoperfusion in all patients treated with PDT with reduced choroidal perfusion persisting to month 12. This did not occur in the sham group. CONCLUSION: The addition of standard-fluence verteporfin PDT at baseline to a ranibizumab regimen conferred no benefit in terms of visual acuity or number of ranibizumab injections required at 1 year. The combination of these treatments resulted in persistent reduced choroidal perfusion, which raises potential safety concerns.
机译：目的：本研究的目的是评估与兰尼单抗单药治疗相比，兰尼单抗方案在治疗与年龄有关的黄斑变性继发的脉络膜新生血管时，使用兰尼单抗方案的第一天进行标准通量Verteporfin光动力疗法（PDT）的效果。方法：患者在基线时随机接受假手术或标准通量韦替泊芬PDT治疗。兰尼单抗的每月三个月负荷剂量中的第一个在同一天给予，此后，患者根据需要每月接受兰尼单抗的治疗。所有患者均接受每月视力和OCT评估，以及3个月的荧光素血管造影，随访期1年。结果：总共招募了18名患者。 PDT组在1年内平均获得2.2个ETDRS字母，而伪造组在1年平均获得4.4个字母（P = 0.47）。两组在3个月的加载阶段后平均需要注射1.3种兰尼单抗。在所有接受PDT治疗的患者中，荧光素血管造影在1个月时显示出明显的脉络膜灌注不足，并持续到第12个月时脉络膜灌注减少。在假手术组中未发生这种情况。结论：在兰尼单抗治疗方案的基础上添加标准通量的维替泊芬PDT在视力或兰尼单抗注射1年所需次数方面均无益处。这些治疗方法的结合导致了脉络膜灌注的持续减少，这引起了潜在的安全隐患。

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