Purpose: 

To evaluate the mean change in visual acuity at 52 weeks in patients with idiopathic choroidal neovascularization treated with aflibercept.

Methods: 

We conducted a prospective noncomparative open-label Phase-II trial. The dosage regimen evaluated in this study was structured into two periods: (1) from inclusion to 20 weeks: a treat-and-extend period composed of three mandatory intravitreal injections, and complementary intravitreal injections performed if needed; (2) from 21 weeks to 52 weeks: a pro re nata period composed of intravitreal injections performed only if needed.

Results: 

A total of 19 patients were included, and 16 completed the 52-week study. At baseline, the mean best corrected visual acuity was 66.56 (±20.72) letters (≈20/50 Snellen equivalent), and the mean central retinal thickness was 376.74 µm (±93.77). At 52 weeks, the mean change in the best-corrected visual acuity was +19.50 (±19.36) letters [95% confidence interval = +9.18 to +29.82]. None of the patients included lost ≥15 letters at 24 weeks or 52 weeks. The mean change in central retinal thickness was −96.78 µm (±104.29) at 24 weeks and −86.22 µm (±112.27) at 52 weeks. The mean number of intravitreal injections was 5.4 (±3.0) at 52-weeks. No ocular serious adverse events related to the treatment were reported.

Conclusion: 

The present analysis shows clinically significant functional and anatomical treatment effect of aflibercept in case of idiopathic choroidal neovascularization. The treat-and-extend regimen proposed after the first injection seems adequate to treat most neovessels.

中文翻译：

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阿柏西普治疗年轻患者特发性脉络膜新生血管的疗效和安全性：直觉研究

目的： 

评估接受阿柏西普治疗的特发性脉络膜新生血管患者 52 周时视力的平均变化。

方法： 

我们进行了一项前瞻性非比较开放标签二期试验。本研究评估的剂量方案分为两个阶段：（1）从纳入到20周：治疗和延长期由三次强制玻璃体内注射组成，如果需要则进行补充玻璃体内注射；(2)21周至52周：预产期，仅在需要时进行玻璃体内注射。

结果： 

总共纳入了 19 名患者，其中 16 名患者完成了为期 52 周的研究。基线时，平均最佳矫正视力为 66.56 (±20.72) 个字母（约 20/50 Snellen 等效值），平均中央视网膜厚度为 376.74 µm (±93.77)。52 周时，最佳矫正视力的平均变化为 +19.50 (±19.36) 个字母 [95% 置信区间 = +9.18 至 +29.82]。所有患者在 24 周或 52 周时均未丢失 ≥15 个字母。24周时中央视网膜厚度的平均变化为-96.78μm （ ±104.29），52周时为-86.22μm（±112.27）。52 周时玻璃体内注射的平均次数为 5.4 (±3.0) 次。没有报告与治疗相关的眼部严重不良事件。

结论： 

本分析显示阿柏西普在特发性脉络膜新生血管形成中具有临床显着的功能和解剖学治疗效果。第一次注射后提出的治疗和延长方案似乎足以治疗大多数新生血管。