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首页> 外文期刊>American Journal of Ophthalmology: The International Journal of Ophthalmology >Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results.
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Ranibizumab combined with verteporfin photodynamic therapy in neovascular age-related macular degeneration (FOCUS): year 2 results.

机译：雷尼单抗联合维替泊芬光动力疗法治疗新生血管性年龄相关性黄斑变性（FOCUS）：第2年结果。

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PURPOSE: To assess the efficacy and adverse-events profile of combined treatment with ranibizumab and verteporfin photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization (CNV) secondary to neovascular age-related macular degeneration. DESIGN: Two-year, multicenter, randomized, single-masked, controlled study. METHODS: Patients received monthly intravitreal injections of ranibizumab 0.5 mg (n = 106) or sham injections (n = 56). All patients received PDT on day zero, then quarterly as needed. Efficacy assessment included changes in visual acuity (VA) and lesion characteristics and PDT frequency. Adverse events were summarized by incidence and severity. RESULTS: At month 24, 88% of ranibizumab + PDT patients had lost <15 letters from baseline VA (vs 75% for PDT alone), 25% had gained >or=15 letters (vs 7% for PDT alone), and the two treatment arms differed by 12.4 letters in mean VA change (P < .05 for all between-group differences). The VA benefit of adding ranibizumab to PDT in year one persisted through year two. On average, ranibizumab + PDT patients exhibited less lesion growth and greater reduction of CNV leakage and subretinal fluid accumulation, and required fewer PDT retreatments, than PDT-alone patients (mean = 0.4 vs 3.0 PDT retreatments). Endophthalmitis and serious intraocular inflammation occurred, respectively, in 2.9% and 12.4% of ranibizumab + PDT patients and 0% of PDT-alone patients. Incidences of serious nonocular adverse events were similar in the two treatment groups. CONCLUSIONS: Through two years, ranibizumab + PDT was more effective than PDT alone and had a low rate of associated adverse events.
机译：目的：评估兰尼单抗与维替泊芬光动力疗法（PDT）联合治疗对继发于新生血管性年龄相关性黄斑变性的经典脉络膜新生血管（CNV）患者的疗效和不良事件。设计：两年，多中心，随机，单掩蔽，对照研究。方法：患者每月接受玻璃体内注射雷珠单抗0.5 mg（n = 106）或假注射（n = 56）。所有患者均在第0天接受PDT，然后根据需要每季度接受一次。疗效评估包括视力（VA），病变特征和PDT频率的变化。不良事件通过发生率和严重性进行了总结。结果：在第24个月，兰尼单抗+ PDT患者从基线VA丢失<15个字母（单独PDT为75％），25％≥15个字母（单独PDT为7％），并且两个治疗臂的平均VA变化相差12.4个字母（对于所有组间差异，P <.05）。在第一年中将兰尼单抗添加到PDT中的VA利益持续到第二年。平均而言，与单独使用PDT的患者相比，兰尼单抗+ PDT患者表现出更少的病灶增长，更大的CNV渗漏减少和视网膜下积液减少，并且需要更少的PDT重新治疗（平均= 0.4 vs 3.0 PDT再治疗）。兰尼单抗+ PDT患者和单独使用PDT的患者分别发生2.9％和12.4％的眼内炎和严重眼内炎症。在两个治疗组中，严重的非眼部不良事件的发生率相似。结论：两年来，兰尼单抗+ PDT比单独使用PDT更有效，并且相关不良事件发生率低。

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