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光学相干断层扫描在葡萄膜炎性黄斑水肿中的解剖和时间生物标志物。

Optical Coherence Tomography Anatomic and Temporal Biomarkers in Uveitic Macular Edema.

机构信息

Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA.

Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA.

出版信息

Am J Ophthalmol. 2022 May;237:310-324. doi: 10.1016/j.ajo.2021.10.024. Epub 2021 Nov 3.

Abstract

PURPOSE

To assess the relationship between best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) features in noninfectious uveitis (NIU)-related macular edema.

DESIGN

Clinical cohort study from post hoc analysis of 2 phase 3 clinical trials.

METHODS

Correlation and longitudinal treatment analyses were performed. Of 198 patients with NIU, 134 received suprachoroidal CLS-TA (proprietary formulation of a triamcinolone acetonide injectable suspension), and 64 received sham, with 12.9% and 72%, respectively, receiving rescue therapy.

RESULTS

At baseline, mean BCVA progressively worsened with each ordinal drop in central subfield ellipsoid zone (EZ) integrity. Eyes with normal baseline EZ experienced greater 24-week change in BCVA versus those with some degree of baseline EZ disruption (11.9 vs 9.4 letters, P = .006). In contrast, eyes with baseline central subfield cystoid spaces and/or subretinal fluid showed more improvement (13.7 or 17.2 letters, respectively) at 24 weeks, versus those without such findings (5.5 [P = .012] or 9.5 letters [P < .001], respectively). Longitudinal modeling for CLS-TA-treated eyes showed that central subfield thickness (CST) reached 90% of maximal improvement by week 3, whereas 90% maximal response in BCVA was not reached until week 9. CLS-TA-treated eyes that showed CST reduction of ≥50 µm at 4 weeks experienced a greater 24-week improvement in BCVA versus those without such an early response (14.6 vs 6.5 letters, P = .006 for difference).

CONCLUSIONS

Pretreatment EZ integrity and the presence of central subfield cystoid spaces or subretinal fluid each predict improved therapeutic response to treatment in eyes with NIU. In CLS-TA treated eyes, longitudinal modeling shows CST improvement preceding BCVA improvement.

摘要

目的

评估非感染性葡萄膜炎(NIU)相关黄斑水肿患者最佳矫正视力(BCVA)与光学相干断层扫描(OCT)特征的关系。

设计

对 2 项 3 期临床试验的事后分析进行临床队列研究。

方法

进行相关性和纵向治疗分析。198 例 NIU 患者中,134 例接受脉络膜上腔 CLS-TA(曲安奈德注射混悬剂的专有配方)治疗,64 例接受假治疗,分别有 12.9%和 72%的患者接受了挽救性治疗。

结果

在基线时,中央子场椭圆区(EZ)完整性每降低一个等级,平均 BCVA 逐渐恶化。基线时 EZ 正常的眼比基线时 EZ 有一定程度破坏的眼 24 周时 BCVA 变化更大(11.9 比 9.4 个字母,P=0.006)。相比之下,基线时有中央子场囊样空间和/或视网膜下液的眼在 24 周时有更多的改善(分别为 13.7 或 17.2 个字母),而无这些发现的眼则分别为 5.5(P=0.012)或 9.5 个字母(P<0.001)。CLS-TA 治疗眼的纵向模型显示,中央子场厚度(CST)在第 3 周时达到最大改善的 90%,而 BCVA 的最大反应在第 9 周时才达到。在第 4 周 CST 减少≥50 μm的 CLS-TA 治疗眼在 24 周时的 BCVA 改善程度大于无此早期反应的眼(14.6 比 6.5 个字母,P=0.006)。

结论

治疗前 EZ 完整性以及中央子场囊样空间或视网膜下液的存在均可预测 NIU 患者对治疗的反应改善。在 CLS-TA 治疗眼,纵向模型显示 CST 改善先于 BCVA 改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/9fb9/10919549/aa529e719c1d/nihms-1957975-f0001.jpg

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