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阿柏西普可减少视网膜出血和玻璃体内微血管异常,但不能减少静脉珠:CLARITY 研究的二次分析。

Aflibercept Reduces Retinal Hemorrhages and Intravitreal Microvascular Abnormalities But Not Venous Beading: Secondary Analysis of the CLARITY Study.

机构信息

Moorfields Biomedical Research Centre, Moorfields Eye Hospital, London, United Kingdom.

Boehringer Ingelheim International GmBH, Ingelheim am Rhein, Germany.

出版信息

Ophthalmol Retina. 2020 Jul;4(7):689-694. doi: 10.1016/j.oret.2020.02.003. Epub 2020 Feb 11.

DOI:10.1016/j.oret.2020.02.003
PMID:32473901
Abstract

PURPOSE

Approximately 50% of patients receiving anti-vascular endothelial growth factor (VEGF) therapy show significant improvement in diabetic retinopathy severity score (DRSS), in particular at DRSS level 47 to 53 (moderately severe to severe nonproliferative diabetic retinopathy). Level 47 to 53 consists of 3 main features: deep hemorrhages (DH), venous beading (VB), and intraretinal microvascular abnormalities (IRMAs). It is unclear whether these features respond to anti-VEGF therapies differently.

DESIGN

Post hoc analysis of Intravitreal Aflibercept versus Panretinal Photocoagulation in Patients with Proliferative Diabetic Retinopathy (CLARITY) study.

PARTICIPANTS

Treatment-naïve participants randomized to intravitreal aflibercept.

METHODS

We reanalyzed the fundus images at baseline, week 12, and week 52 to assess the changes of the 3 main features in DRSS level 47 to 53 in those patients who were treatment naïve and had received aflibercept.

MAIN OUTCOME MEASURES

Changes in DH, VB, and IRMA after aflibercept therapy at weeks 12 and 52.

RESULTS

Fifty-five treatment-naïve eyes at baseline that received aflibercept were included in the study. Severe DH and severe IRMA improved in approximately 75% of eyes at week 12 and mostly remained improved at week 52; VB remained unchanged in all eyes at week 12. From 12 weeks, 32 eyes that had received injections showed improved or stable DH compared with 7 eyes that did not receive injections, and DH deteriorated in 6 eyes with no further injections compared with 4 eyes that had received more injections (P = 0.0072). Similarly, 15 eyes that continued to receive injections from week 12 showed improved or stable IRMA compared with 4 who did not receive injections (P = 0.006). Worsening of IRMA was seen in 5 eyes with no further injections compared with 4 eyes that continued to receive injections. The improvements in DH and IRMA are more likely to be maintained if less than 16 weeks have elapsed since the last anti-VEGF injection.

CONCLUSIONS

Aflibercept seems to improve DH and IRMA after just 3 injections. As soon as the frequency of injections were reduced, DH and IRMA can deteriorate again. It is unclear whether these results can be translated to patients without PDR.

摘要

目的

约 50%接受抗血管内皮生长因子(VEGF)治疗的患者的糖尿病视网膜病变严重程度评分(DRSS)有显著改善,特别是在 DRSS 47 至 53 级(中度至重度非增生性糖尿病视网膜病变)。47 至 53 级包括 3 个主要特征:深层出血(DH)、静脉串珠(VB)和视网膜内微血管异常(IRMA)。目前尚不清楚这些特征对抗 VEGF 治疗的反应是否不同。

设计

增殖性糖尿病视网膜病变患者玻璃体腔内阿柏西普与全视网膜光凝治疗的随机对照研究(CLARITY)的事后分析。

参与者

接受玻璃体腔内阿柏西普治疗的初治患者。

方法

我们重新分析了基线、12 周和 52 周的眼底图像,以评估初治且接受阿柏西普治疗的患者 DRSS 47 至 53 级中 3 个主要特征的变化。

主要观察指标

阿柏西普治疗 12 周和 52 周后 DH、VB 和 IRMA 的变化。

结果

55 只基线时初治且接受阿柏西普治疗的眼纳入研究。严重 DH 和严重 IRMA 在 12 周时约 75%的眼改善,在 52 周时大多保持改善;所有眼 VB 在 12 周时均无变化。从 12 周开始,与未注射的 7 只眼相比,32 只接受注射的眼的 DH 改善或稳定,与未接受注射的 4 只眼相比,6 只眼的 DH 恶化且未再接受注射(P = 0.0072)。同样,从 12 周开始继续接受注射的 15 只眼的 IRMA 改善或稳定,与未接受注射的 4 只眼相比(P = 0.006)。与继续接受注射的 4 只眼相比,5 只眼不再接受注射的 IRMA 恶化。如果距离最后一次抗 VEGF 注射不到 16 周,DH 和 IRMA 的改善更有可能持续。

结论

阿柏西普似乎在仅 3 次注射后即可改善 DH 和 IRMA。一旦减少注射频率,DH 和 IRMA 就可能再次恶化。目前尚不清楚这些结果是否可以转化为没有 PDR 的患者。

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