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首页> 外文期刊>Journal of Ophthalmology >Efficacy and Safety of an Aflibercept Treat-and-Extend Regimen in Treatment-Naïve Patients with Macular Oedema Secondary to Central Retinal Vein Occlusion (CRVO): A Prospective 12-Month, Single-Arm, Multicentre Trial
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Efficacy and Safety of an Aflibercept Treat-and-Extend Regimen in Treatment-Naïve Patients with Macular Oedema Secondary to Central Retinal Vein Occlusion (CRVO): A Prospective 12-Month, Single-Arm, Multicentre Trial

机译：Ablibercept治疗和扩展方案对未接受过治疗的视网膜中央静脉阻塞（CRVO）继发黄斑水肿的患者的疗效和安全性：一项为期12个月的单臂多中心试验

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Objectives. To evaluate efficacy and safety of an aflibercept treat-and-extend (TAE) regimen in patients with macular oedema (MO) secondary to central retinal vein occlusion (CRVO). Design, Setting, and Patients. Phase IV, prospective, open-label, single-arm trial in 11 Spanish hospitals. Treatment-na?ve patients with 6 month diagnosis of MO secondary to CRVO and best-corrected visual acuity (BCVA) of 73-24 ETDRS letters were included between 23 January 2015 and 17 March 2016. Intervention. Intravitreal aflibercept 2?mg monthly (3 months) followed by proactive individualized dosing. Main Outcomes. Mean change in BCVA after 12 months. Results. 24 eyes (24 patients) were included; mean (SD) age 62.8 (15.0) years; 54.2% male; median (IQR) time since diagnosis 7.6 (3.0, 15.2) days. Mean BCVA scores significantly improved between baseline (56.0 (16.5)) and Month 12 (74.1 (17.6)); mean (95% CI) change 14.8 (8.2, 21.4); . Twelve (50.0%) patients gained ≥15 ETDRS letters. Foveal thickness improved between baseline (mean 569.4 (216.8)?μm) and Month 12 (mean 257.4 (48.4)?μm); . At Month 12, 8.3% patients had MO. The mean (SD) number of injections 8.3 (3.0). No treatment-related AEs were reported. Five (20.8%) patients experienced ocular AEs. Two nonocular serious AEs were reported. Conclusions. An aflibercept TAE regimen improves visual acuity in patients with MO secondary to CRVO over 12 months with good tolerability.
机译：目标。评估aflibercept治疗并扩展（TAE）方案对继发于视网膜中央静脉阻塞（CRVO）的黄斑水肿（MO）患者的疗效和安全性。设计，设置和患者。第四阶段，在西班牙的11家医院进行的前瞻性开放标签单臂试验。在2015年1月23日至2016年3月17日期间，接受初治的CRVO继发MO ＜6个月的初治患者和73-24枚ETDRS字母的最佳矫正视力（BCVA）被纳入研究。玻璃体内aflibercept每月2mg（3个月），然后主动进行个性化给药。主要结果。 12个月后BCVA的平均变化。结果。纳入24只眼（24例）;平均（SD）年龄62.8（15.0）岁;男性54.2％;自诊断以来的中位数（IQR）时间为7.6（3.0，15.2）天。在基线（56.0（16.5））和第12个月（74.1（17.6））之间，平均BCVA分数显着提高;平均（95％CI）变化14.8（8.2，21.4）; 。 12名（50.0％）患者获得了≥15个ETDRS字母。在基线（平均569.4（216.8）？μm）和第12个月（平均257.4（48.4）？μm）之间，中央凹厚度得到改善; 。在第12个月，有8.3％的患者患有MO。平均（SD）注射次数8.3（3.0）。没有报道与治疗有关的不良事件。五（20.8％）例患者经历了眼部AE。据报道有两种非眼部严重不良事件。结论。 aflibercept TAE方案可在12个月内改善CRVO继发MO的患者的视力，并且具有良好的耐受性。

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