一项针对中国患者的48周随机4期研究（STAR研究）的结果：玻璃体内注射康柏西普治疗息肉样脉络膜血管病变的两种不同策略的比较。
The comparison of two different strategies of intravitreal conbercept for polypoidal choroidal vasculopathy in Chinese patients results from a 48-week randomized phase 4 study: STAR study.
作者信息
Li Xiaoxin, Qu Jinfeng, Su Guanfang, Yu Suqin, Zhang Yongjin, Sadda Srini Vas
机构信息
Xiamen Eye Center of Xiamen University, Xiamen, China.
Department of Ophthalmology, Peking University People's Hospital, Beijing, China.
出版信息
Acta Ophthalmol. 2023 May;101(3):e327-e337. doi: 10.1111/aos.15272. Epub 2022 Oct 18.
PURPOSE
To compare a treat-and-extend (TAE) strategy with a fixed dosing regimen of intravitreal conbercept (IVC) for the management of treatment-naïve polypoidal choroidal vasculopathy (PCV) patients.
METHODS
249 patients with treatment-naïve PCV were randomized 1:1 to fixed dosing regimen with injections every 12 weeks (3 + Q12W) group or treat-and-extend regimen(3 + TAE) group. Patients received 3 monthly intravitreal injections of 0.5 mg conbercept as loading dose in both groups. The 3 + Q12W patients were monitored monthly and received mandated injections every 12 weeks; the 3 + TAE patients were monitored and treated monthly until the resolution of exudative disease activity; the interval between visits was then individualized according to study protocol. Visual and anatomical outcomes were compared between the two groups.
RESULTS
At 48 weeks, there was no significant difference between the 3 + Q12W group and 3 + TAE group in mean BCVA improvement (p = 0.421), mean changes in central retinal thickness (CRT) (p = 0.818), maximum retinal thickness (MRT) (p = 0.448), pigment epithelial detachment (PED) height (p = 0.221), PED volume (p = 0.076), branching vascular network (BVN) area (p = 0.615), polypoidal lesion number (p = 0.701), polypoidal lesion area (p = 0.424), rates of patients who avoided vision loss of ≥15 ETDRS letters (p = 0.397) or complete polypoidal lesion regression rate (43.8% vs. 41.8%, p = 0.814). The 3 + Q12W group had more decreased retinal haemorrhage area (p = 0.014) and fewer mean numbers of injections comparing with 3 + TAE group (6.6 vs. 9.4, p < 0.001). Mean maximum extension interval between injections after loading injections was 9.6 ± 2.0 weeks for 3 + TAE group, with 27.8% of patients achieving an extension interval of 12 weeks and 61.1% patients 8 weeks or more.
CONCLUSIONS
Both 3 + Q12W and 3 + TAE regimens of IVC could result in improvement in visual and anatomical outcomes in PCV patients.
目的
比较治疗并延长（TAE）策略与玻璃体内注射康柏西普（IVC）固定给药方案在初治息肉状脉络膜血管病变（PCV）患者管理中的效果。
方法
249例初治PCV患者按1:1随机分为每12周注射一次的固定给药方案组（3+Q12W）或治疗并延长方案组（3+TAE）。两组患者均接受3次每月一次的0.5mg康柏西普玻璃体内注射作为负荷剂量。3+Q12W组患者每月监测一次，每12周接受规定注射；3+TAE组患者每月监测并治疗，直至渗出性疾病活动消退；然后根据研究方案对就诊间隔进行个体化调整。比较两组的视力和解剖学结果。
结果
在48周时，3+Q12W组和3+TAE组在平均最佳矫正视力改善（p=0.421）、视网膜中央厚度（CRT）平均变化（p=0.818）、最大视网膜厚度（MRT）（p=0.448）、色素上皮脱离（PED）高度（p=0.221）、PED体积（p=0.076）、分支血管网络（BVN）面积（p=0.615）、息肉样病变数量（p=0.701）、息肉样病变面积（p=0.424）、避免视力丧失≥15个ETDRS字母的患者比例（p=0.397）或息肉样病变完全消退率（43.8%对41.8%，p=0.814）方面无显著差异。与3+TAE组相比，3+Q12W组视网膜出血面积减少更多（p=0.014），平均注射次数更少（6.6次对9.4次，p<0.001）。3+TAE组负荷注射后平均最大注射间隔为9.6±2.0周，27.8%的患者达到12周的延长间隔，61.1%的患者达到8周或更长。
结论
IVC的3+Q12W和3+TAE方案均可使PCV患者的视力和解剖学结果得到改善。
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