UNASSIGNED: Comparative cohort study of randomly selected patients from a multicenter, randomized controlled clinical trial.
UNASSIGNED: Thirty randomly selected patients from the EVEREST II study who were treated with combination ranibizumab and verteporfin photodynamic therapy (n = 15) or ranibizumab monotherapy (n = 15).
UNASSIGNED: All patients were randomized at baseline and treated with a standardized treatment protocol. Indocyanine green angiography (ICGA) images were graded at the central reading center at baseline and months 3, 6, 12, and 24. Polypoidal lesions present at baseline were overlaid on ICGA images at subsequent visits to determine if these remained perfused or had regressed completely. New polypoidal lesions occurring at subsequent visits were similarly tracked to detail the evolution of each polypoidal lesion.
UNASSIGNED: Complete polypoidal lesion regression over time.
UNASSIGNED: Complete polypoidal lesion regression was higher in the combination therapy group compared with the monotherapy group at all visits (month 12, 12 of 15 patients [80%] vs. 5 of 14 patients [35.7%]; P = 0.016). Persistence of baseline polypoidal lesions was lower in the combination therapy group: 1 of 15 patients (6.7%) versus 7 of 14 patients (50%) in the monotherapy group at month 12. Recurrences of polypoidal lesions that had regressed completely at an earlier time point were uncommon: 0% in the combination therapy group and 1 patient each at months 6 and 12 in the monotherapy group. Fewer new polypoidal lesions (arising after the baseline visit) were found in the combination therapy group at all visits (combination therapy: 2 of 15 [13.3%] vs. monotherapy: 4 of 14 eyes [28.6%] at month 12). Total polypoidal lesion area was significantly smaller in the combination therapy group compared with the monotherapy group throughout the study (0.013 mm2 vs. 0.110 mm2; P < 0.01 at month 12).
UNASSIGNED: Combination therapy was associated with higher rates of complete polypoidal lesion regression and fewer persistent polypoidal lesions compared with monotherapy. Closed polypoidal lesions rarely reopened, regardless of the treatment.
UNASSIGNED:多中心随机选择患者的比较队列研究,随机对照临床试验。
UNASSIGNED:从EVERESTII研究中随机选择的30名患者接受雷珠单抗和维替泊芬光动力疗法(n=15)或雷珠单抗单药疗法(n=15)联合治疗。
UNASSIGNED:所有患者在基线时进行随机分组,并采用标准化治疗方案进行治疗。在基线和第3、6、12和24个月,在中央阅读中心对吲哚菁绿血管造影(ICGA)图像进行分级。在随后的访问中将基线时存在的息肉状病变覆盖在ICGA图像上,以确定这些病变是否仍然灌注或完全消退。类似地跟踪在随后的访问中出现的新息肉状病变,以详细说明每个息肉状病变的演变。
未经证实:息肉样病变随时间完全消退。
UNASSIGNED:在所有就诊时,联合治疗组的息肉样病变完全消退高于单一治疗组(12个月,15例患者中的12例[80%]vs.14例患者中有5例[35.7%];P=0.016)。在联合治疗组中,基线息肉样病变的持续时间较低:在12个月时,15名患者中有1名(6.7%),而单药治疗组中有14名患者中有7名(50%)。在较早时间点完全消退的息肉样病变的复发并不常见:联合治疗组为0%,单一治疗组为6和12个月时各1名患者。在所有访问中,联合治疗组中发现的新息肉样病变(在基线访问后出现)较少(联合治疗:15个中的2个[13.3%]与单一疗法:14只眼中的4只眼[28.6%]在12个月时)。在整个研究过程中,与单药治疗组相比,联合治疗组的息肉状病变总面积明显较小(0.013mm2vs.0.110mm2;12个月时P<0.01)。
UNASSIGNED:与单药治疗相比,联合治疗与更高的息肉样病变完全性消退率和更少的持续性息肉样病变相关。闭合性息肉样病变很少再开放,不管治疗。