玻璃体内注射阿柏西普治疗渗出型年龄相关性黄斑变性患者的眼内液与视力的关系：来自 ALTAIR 研究的亚组和事后分析。

Relationship between retinal fluid and visual acuity in patients with exudative age-related macular degeneration treated with intravitreal aflibercept using a treat-and-extend regimen: subgroup and post-hoc analyses from the ALTAIR study.

机构信息

Department of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.

Department of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan.

出版信息

Graefes Arch Clin Exp Ophthalmol. 2021 Dec;259(12):3637-3647. doi: 10.1007/s00417-021-05293-y. Epub 2021 Jul 20.

PURPOSE

To explore the relationship between retinal fluid status and best-corrected visual acuity (BCVA) in patients treated with intravitreal aflibercept (IVT-AFL) treat-and-extend (T&E) in the ALTAIR study.

METHODS

Outcomes were investigated according to overall fluid status at week 16 (predefined) and the relationship between any fluid, intraretinal fluid (IRF), subretinal fluid (SRF), or pigment epithelial detachment with BCVA at baseline, and weeks 16, 52, and 96 (post-hoc). The analyses involved treatment-naïve patients (N = 246) with exudative age-related macular degeneration (AMD), aged ≥ 50 years with BCVA of 73-25 Early Treatment Diabetic Retinopathy Study letters, who participated in the ALTAIR study.

RESULTS

The mean (standard deviation) change in BCVA from baseline to week 52 was + 10.6 (10.9) and + 6.5 (16.0) letters in patients without and with fluid at week 16, respectively; and to week 96 was + 9.1 (14.3) and + 4.3 (16.1) letters in patients without and with fluid at week 16, respectively. The last injection interval was 16 weeks in 33.6% and 2.0% (week 52), and 62.9% and 17.6% (week 96) of patients without or with fluid at week 16, respectively. At baseline, 35.7% of patients had IRF and 85.2% of patients had SRF, which decreased to 11.8% (IRF) and 31.7% (SRF) of patients, 8.5% (IRF) and 18.7% (SRF), and 6.5% (IRF) and 20.7% (SRF) at weeks 16, 52, and 96, respectively. Presence of IRF at all timepoints was associated with poorer BCVA than if IRF was absent, while the presence of SRF was not associated with poorer BCVA compared with the absence of SRF.

CONCLUSION

IVT-AFL T&E dosing was effective at clearing fluid regardless of fluid type in ~ 80% of patients with exudative AMD. Patients without fluid at week 16 had numerically better BCVA than those with fluid at week 16. Over 60% of patients without fluid at week 16 achieved the maximum treatment interval of 16 weeks by study end, compared with < 20% of patients with fluid at week 16. IRF (weeks 16, 52, 96), although evident in a small number of patients, was associated with poorer BCVA, whereas SRF was not.

TRIAL REGISTRATION

ClinicalTrials.gov Identifier: NCT02305238.

目的

在 ALTAIR 研究中，探讨玻璃体内注射阿柏西普（IVT-AFL）治疗和延长（T&E）治疗的患者中视网膜液状态与最佳矫正视力（BCVA）之间的关系。

方法

根据第 16 周（预先定义）的总体液体状态和基线时任何液体、视网膜内液（IRF）、视网膜下液（SRF）或色素上皮脱离与 BCVA 的关系，对结果进行了评估，以及第 16、52 和 96 周（事后）。该分析涉及无治疗的渗出性年龄相关性黄斑变性（AMD）患者（N=246），年龄≥50 岁，BCVA 为 73-25 个早期治疗糖尿病视网膜病变研究字母，参加了 ALTAIR 研究。

结果

从基线到第 52 周，无液体患者的 BCVA 平均（标准差）变化为+10.6（10.9）和+6.5（16.0）个字母，而有液体的患者分别为+9.1（14.3）和+4.3（16.1）个字母；无液体患者至第 96 周的最后一次注射间隔为 16 周，分别为 33.6%和 2.0%（第 52 周），有液体患者至第 96 周的最后一次注射间隔为 62.9%和 17.6%（第 96 周）。基线时，35.7%的患者有 IRF，85.2%的患者有 SRF，分别减少到第 16、52 和 96 周时的 11.8%（IRF）和 31.7%（SRF）、8.5%（IRF）和 18.7%（SRF）和 6.5%（IRF）和 20.7%（SRF）。所有时间点存在 IRF 与不存在 IRF 相比，BCVA 较差，而存在 SRF 与不存在 SRF 相比，BCVA 无差异。

结论

IVT-AFL T&E 给药可有效清除液体，无论渗出性 AMD 患者的液体类型如何，约 80%的患者有效。第 16 周无液体的患者的 BCVA 好于第 16 周有液体的患者。到研究结束时，60%以上的第 16 周无液体的患者达到了 16 周的最大治疗间隔，而第 16 周有液体的患者不到 20%。IRF（第 16、52、96 周）尽管在少数患者中明显存在，但与较差的 BCVA 相关，而 SRF 则没有。