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真实世界中玻璃体内注射阿柏西普治疗糖尿病黄斑水肿:36 个月视力和解剖学结局。

Intravitreal aflibercept for diabetic macular oedema in real-world: 36-month visual acuity and anatomical outcomes.

机构信息

NIHR Biomedical Research Centre, 4960Moorfields Eye Hospital NHS Foundation Trust and UCL Institute of Ophthalmology, London, UK.

出版信息

Eur J Ophthalmol. 2021 May;31(3):1201-1207. doi: 10.1177/1120672120925034. Epub 2020 May 19.

Abstract

BACKGROUND/AIMS: To assess structural and functional outcomes of treatment with intravitreal aflibercept (®Eylea) for diabetic macular oedema in treatment-naïve patients.

METHODS

Sixty-four eyes receiving intravitreal anti-vascular endothelial growth factor therapy were included in the data analysis of this retrospective, real-life study which follow-up was 3 years. Each patient had corrected visual acuity in Early Treatment Diabetic Retinopathy Study letters and optical coherence tomography central foveal thickness and macular volume performed at baseline, 12, 24 and 36 months. Patients were initiated on a loading phase of five 1-monthly intravitreal aflibercept injections, followed by injections if needed as per clinicians' discretion.

RESULTS

The mean number of aflibercept injections received over 3 years was 12.59. At baseline, the mean visual acuity (standard deviation) (Snellen) was 61.45 (16.30) (20/63) Early Treatment Diabetic Retinopathy Study letters, the mean central foveal thickness (standard deviation) was 422 (138) µm, while the mean macular volume (standard deviation) was 9.51 (2.01) mm. At 36 months, the mean visual acuity (standard deviation) (Snellen) was 68.34 (13.66) (20/50) Early Treatment Diabetic Retinopathy Study letters (p = .0003). Mean central foveal thickness (standard deviation) was 303 (106) µm (p < .0001) and mean macular volume (standard deviation) was 8.35 (1.62) mm (p = .0022) at 36 months. Sixteen (25%) eyes gained ≥15 ETDRS letters at month 36, and 33 (52%) eyes had a decrease in central foveal thickness of ≥ 100 µm at the same time.

CONCLUSION

There was a significant improvement in visual acuity and in anatomical outcomes in aflibercept-treated eyes at 36 months after commencing treatment for diabetic macular oedema in real-life settings. The good vision and anatomical outcomes were maintained over second and third year of treatment with mean 2.93 and 2.57 intravitreal injections, respectively.

摘要

背景/目的:评估玻璃体内注射阿柏西普(®Eylea)治疗初治糖尿病黄斑水肿的结构和功能结果。

方法

本回顾性真实世界研究共纳入 64 只接受玻璃体内抗血管内皮生长因子治疗的眼,随访 3 年。每位患者在基线、12、24 和 36 个月时均进行最佳矫正视力(早期糖尿病视网膜病变研究字母)和光学相干断层扫描中心凹视网膜厚度和黄斑体积检查。患者接受了 5 个 1 个月的玻璃体内阿柏西普负荷期治疗,然后根据临床医生的判断进行注射。

结果

3 年内平均接受阿柏西普注射 12.59 次。基线时,平均视力(标准差)(Snellen)为 61.45(16.30)(20/63)早期糖尿病视网膜病变研究字母,平均中心凹视网膜厚度(标准差)为 422(138)µm,平均黄斑体积(标准差)为 9.51(2.01)mm。36 个月时,平均视力(标准差)(Snellen)为 68.34(13.66)(20/50)早期糖尿病视网膜病变研究字母(p=0.0003)。平均中心凹视网膜厚度(标准差)为 303(106)µm(p<0.0001),平均黄斑体积(标准差)为 8.35(1.62)mm(p=0.0022),36 个月时。16 只(25%)眼在第 36 个月时获得≥15 个 ETDRS 字母,33 只(52%)眼中心凹视网膜厚度减少≥100µm。

结论

在现实环境中开始治疗糖尿病黄斑水肿后 36 个月,阿柏西普治疗眼的视力和解剖学结果均有显著改善。在第二年和第三年的治疗中,分别平均注射 2.93 次和 2.57 次,视力和解剖学结果保持良好。

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