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在 In-Eye 研究中,接受每月两次、按需治疗和按需治疗的 ranibizumab 治疗的新生血管性年龄相关性黄斑变性患者中,视网膜内和视网膜下液对临床和解剖结果的作用。

Role of intraretinal and subretinal fluid on clinical and anatomical outcomes in patients with neovascular age-related macular degeneration treated with bimonthly, treat-and-extend and as-needed ranibizumab in the In-Eye study.

机构信息

Department of Ophthalmology, Clínica Universidad de Navarra, Pamplona, Spain.

Experimental Ophthalmology Laboratory, Universidad de Navarra, Pamplona, Spain.

出版信息

Acta Ophthalmol. 2021 Dec;99(8):861-870. doi: 10.1111/aos.14786. Epub 2021 Mar 15.

Abstract

PURPOSE

To assess the effect of fluid status at baseline (BL) and at the end of the loading phase (LP) of three different ranibizumab regimens: treat-and-extend (T&E), fixed bimonthly (FBM) injections and pro re nata (PRN), in patients with neovascular age-related macular degeneration (nAMD).

DESIGN

Post hoc analysis of the In-Eye study (phase IV clinical trial).

METHODS

Patients were randomized 1:1:1 to the three study arms and were treated accordingly. The presence and type of fluid, intraretinal fluid (IRF) or subretinal fluid (SRF) and the anatomical and visual outcomes were analysed.

MAIN OUTCOME MEASURES

Best-corrected visual acuity (BCVA), the mean change from baseline BCVA (BL BCVA), and the proportion of eyes gaining more than 15 letters or losing more than five letters were analysed. Morphological characteristics including the subtype of choroidal neovascular membrane and the development of atrophy and fibrosis were also evaluated.

RESULTS

Patients with SRF at LP had better visual outcomes than patients with IRF. The persistence of SRF did not affect the mean change from BL BCVA among the three treatment regimens. However, in patients with IRF mean change from BL BCVA was significantly lower in the FBM group. The presence of IRF at BL and at the end of the loading phase was associated with the development of fibrosis at the end of the study; this result was contrary to that observed for patients with SRF.

CONCLUSIONS

While SRF is compatible with good visual and anatomical outcomes, IRF leads to worse results in patients with nAMD; our results suggest that patients with IRF have better outcomes when individualized treatment regimens are used (PRN or T&E) in contrast with a FBM regimen.

摘要

目的

评估三种不同雷珠单抗治疗方案(即按需治疗与延长治疗、固定每两个月治疗、灵活治疗)在基线(BL)和负荷期(LP)时的液体状态对新生血管性年龄相关性黄斑变性(nAMD)患者的影响。

设计

In-Eye 研究(IV 期临床试验)的事后分析。

方法

患者按 1:1:1 随机分为三组,并接受相应治疗。分析液体的存在和类型、视网膜内液(IRF)或视网膜下液(SRF)以及解剖和视觉结果。

主要观察指标

最佳矫正视力(BCVA)、BL BCVA 的平均变化(BL BCVA)以及增加超过 15 个字母或减少超过 5 个字母的眼数比例。还评估了形态学特征,包括脉络膜新生血管膜的亚型以及萎缩和纤维化的发展。

结果

LP 时有 SRF 的患者比有 IRF 的患者有更好的视力结果。在三种治疗方案中,SRF 的持续存在并不影响从 BL BCVA 的平均变化。然而,在有 IRF 的患者中,FBM 组的 BL BCVA 平均变化明显较低。BL 和负荷期结束时存在 IRF 与研究结束时纤维化的发展有关;这一结果与观察到的 SRF 患者的结果相反。

结论

虽然 SRF 与良好的视觉和解剖结果兼容,但 IRF 会导致 nAMD 患者的结果更差;我们的结果表明,与 FBM 方案相比,IRF 患者使用个体化治疗方案(PRN 或 T&E)时的结果更好。

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