Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age-related macular degeneration
Randomized multicenter trial of more intense and standard early verteporfin treatment of neovascular age-related macular degeneration
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DOI：
10.1016/j.ophtha.2007.02.033
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发表时间：
2008-01-01
期刊：
影响因子：
13.7
通讯作者：
Sacu, Stefan
中科院分区：
文献类型：
--
作者：
Schmidt-Erfurth, Ursula;Sacu, Stefan
目的：在维替泊芬治疗（VT）的早期，比较一种更强的治疗方案与一种标准治疗方案对新生血管性年龄相关性黄斑变性（AMD）再治疗的有效性和安全性。设计：前瞻性、随机、多中心临床试验。参与者：203例继发于AMD的典型脉络膜新生血管（CNV）患者。方法：在VT的前6个月，患者每2个月（A组）或3个月（B组）接受一次再治疗。6个月后，两组患者每3个月进行一次再治疗，直到记录到CNV活动。每6个月测量一次的最佳矫正视力（BCVA），24个月随访期间每例患者的平均治疗次数，每组中视力丧失至少3行或增加至少1行的患者比例，每6个月通过荧光素血管造影记录病变的最大线性尺寸（GLD），以及初始病变大小与BCVA之间的关系。结果：在所有随访时间，A组和B组的平均BCVA相似。两组的光动力疗法治疗的平均次数相似（4.07 vs. 4.36; P = 0.451，配对t检验）。A组中24个月时至少丧失3条视力的患者比例较低（51.9% vs 56.7%）。A组和B组从基线至24个月的平均病变大小增加相似（2104 - 3056 μ m和2179 - 3020 μ m）。24个月时，A组基线病变GLD为2000 μ m的患者（P = 0.032）; A组GLD为
Purpose: To compare efficacy and safety of a more intense regimen versus a standard one for retreatment of neovascular age-related macular degeneration (AMD) during the early period of verteporfin therapy (VT).Design: Prospective, randomized, multicenter clinical trial.Participants: Two hundred three patients with predominantly classic choroidal neovascularization (CNV) secondary to AMD.Methods: During the first 6 months of VT, patients underwent retreatment every 2 (group A) or 3 (group B) months. After 6 months, both groups underwent retreatment every 3 months for as long as CNV activity was documented.Main Outcome Measures: Best-corrected visual acuity (BCVA) measured every 6 months, mean number of treatments per patient during 24 months' follow-up, proportions of patients in each group losing at least 3 lines of vision or gaining at least 1 line, greatest linear dimension (GLD) of the lesion as documented by fluorescein angiography every 6 months, and relationship between initial lesion size and BCVA.Results: At all follow-up times, mean BCVAs were similar for groups A and B. Mean numbers of photodynamic therapy treatments were similar for both groups (4.07 vs. 4.36; P = 0.451, paired t test). A lower proportion (51.9% vs. 56.7%) of patients in group A had lost at least 3 lines of vision at 24 months. Groups A and B had similar increases in mean lesion size from baseline to 24 months (2104-3056 mu m and 2179-3020 mu m). At 24 months, patients in group A with a baseline lesion GLD of :2000 mu m (P = 0.032); differences also were significant for group A with GLD of