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眼内阿柏西普治疗伴脉络膜血管样条纹的脉络膜新生血管:意大利 EYLEA-STRIE 研究。

Intravitreal aflibercept for management of choroidal neovascularization secondary to angioid streaks : The Italian EYLEA-STRIE study.

机构信息

San Raffaele Scientific Institute, Milano, Italy.

Universita Vita-Salute San Raffaele, Milano, Italy.

出版信息

Eur J Ophthalmol. 2021 May;31(3):1146-1153. doi: 10.1177/1120672120928305. Epub 2020 Jun 2.

Abstract

PURPOSE

To investigate the effect and the safety of intravitreal aflibercept in patients affected by choroidal neovascularization secondary to angioid streaks with a long-term follow-up.

METHODS

Multicentre, open-label, phase IIb study (EYLEA-STRIE, EudraCT Number 2014-000986-30) involving four Italian centres (IRCCS Ospedale San Raffaele (Milano), Fondazione G.B. Bietti (Roma), Policlinico (Milano), Ospedale Luigi Sacco (Milano)). Patients with active choroidal neovascularization secondary to angioid streaks with foveal involvement were prospectively enrolled and followed for 18 months. All the patients received intravitreal 2 mg/0.05 mL aflibercept at the time of enrolment, followed by a regimen for 48 weeks. Best-corrected visual acuity and central macular thickness were measured monthly. Adverse events were monitored at each visit.

RESULTS

Twenty-three eyes of 20 patients were analysed. Mean number of injections per patient was 4.30 ± 1.2. At week 48, the best-corrected visual acuity was 0.42 ± 0.40 LogMAR (p = 0.6 from baseline) and 18 eyes (81.8%) featured stability within 15 letters. The central macular thickness significantly reduced (p = 0.03). Eleven ocular non-serious adverse events and two serious adverse events were observed (one case of endophthalmitis and one case of acute gastritis were reported).

CONCLUSION

Intravitreal aflibercept represents a valid option for the management of choroidal neovascularization complicating angioid streaks. Further studies with longer follow-up and different therapeutic regimens are warranted to ascertain the best control of the disease.

摘要

目的

研究玻璃体内注射阿柏西普治疗伴有长期随访的脉络膜新生血管(CNV)的变性条纹的安全性和疗效。

方法

这是一项多中心、开放标签、Ⅱb 期临床试验(EYLEA-STRIE,EudraCT 编号 2014-000986-30),纳入了意大利的 4 个中心(米兰的圣拉斐尔研究所医院(IRCCS Ospedale San Raffaele)、罗马的比埃蒂基金会(Fondazione G.B. Bietti)、米兰的 Policlinico 医院、米兰的 Luigi Sacco 医院)。前瞻性纳入伴有黄斑受累的活动性 CNV 的变性条纹患者,并随访 18 个月。所有患者在入组时接受玻璃体内注射 2mg/0.05ml 的阿柏西普,随后进行 48 周的治疗方案。每月测量最佳矫正视力和中心黄斑厚度。每次就诊时监测不良事件。

结果

20 例患者的 23 只眼纳入分析。每位患者的平均注射次数为 4.30±1.2。在第 48 周,最佳矫正视力为 0.42±0.40 LogMAR(与基线相比无统计学差异,p=0.6),18 只眼(81.8%)视力稳定在 15 个字母内。中心黄斑厚度显著降低(p=0.03)。观察到 11 例眼部非严重不良事件和 2 例严重不良事件(报告了 1 例眼内炎和 1 例急性胃炎)。

结论

玻璃体内注射阿柏西普是治疗变性条纹合并脉络膜新生血管的有效选择。需要进一步进行具有更长随访时间和不同治疗方案的研究,以确定对疾病的最佳控制。

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