Purpose

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

Design

Clinical cohort study from post hoc analysis of two phase 3 clinical trials’ data.

Methods

Correlation and longitudinal treatment analyses were performed. Of 198 patients with NIU, 134 received suprachoroidally administered CLS-TA (Clearside Biomedical, Inc. 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 ellipsoid zone (EZ) integrity. Eyes with normal baseline EZ experienced greater 24-week change in BCVA compared to eyes with some degree of baseline EZ disruption (11.9 vs 9.4 letters, P=0.006). In contrast, eyes without central subfield cystoid spaces and/or central subfield SRF at baseline showed less improvement (5.5 letters or 9.5 letters, respectively) at 24 weeks, compared to those eyes with such OCT findings (13.7 letters, P = 0.012 or 17.2 letter, P <0.001, respectively). Longitudinal modeling for CLS-TA treated eyes showed that central subfield thickness (CST) reached 90% of maximal improvement by week three, whereas 90% maximal response in BCVA was not reached until week nine. NIU-ME eyes receiving CLS-TA that showed a CST reduction of ≥ 50 µm at 4 weeks experienced a greater 24-week improvement in BCVA, compared to those without such an early response (14.6 vs 6.5 letters, P=0.006 for difference).

Conclusion

Pre-treatment EZ integrity and the presence of central subfield cystoid spaces or SRF each predict improved therapeutic response to treatment in eyes with NIU.

中文翻译：

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葡萄膜炎黄斑水肿的 OCT 解剖和时间生物标志物

目的

评估非感染性葡萄膜炎 (NIU) 相关黄斑水肿 (ME) 的最佳矫正视力 (BCVA) 和中心亚场光学相干断层扫描 (OCT) 特征之间的关系。

设计

对两项 3 期临床试验数据进行事后分析的临床队列研究。

方法

进行了相关性和纵向治疗分析。在 198 名 NIU 患者中，134 名接受了脉络膜上给药 CLS-TA（Clearside Biomedical, Inc. 专有配方的曲安奈德可注射混悬液），64 名接受了假手术，分别有 12.9% 和 72% 接受了抢救治疗。

结果

在基线时，平均 BCVA 会随着椭圆体区 (EZ) 完整性的每个顺序下降而逐渐恶化。与具有一定程度的基线 EZ 破坏的眼睛相比，具有正常基线 EZ 的眼睛在 24 周内的 BCVA 变化更大（11.9 对 9.4 个字母，P=0.006）。相比之下，与具有此类 OCT 发现的眼睛（13.7 个字母，P = 0.012 或 17.2字母，分别为 P <0.001）。CLS-TA 治疗眼睛的纵向模型显示，中央亚视野厚度 (CST) 到第三周达到最大改善的 90%，而 BCVA 的最大反应直到第九周才达到 90%。

结论

治疗前 EZ 完整性和中央亚场囊样空间或 SRF 的存在都预示着 NIU 眼对治疗的治疗反应得到改善。