Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA.
Clearside Biomedical, Inc (T.A.C., B.K.), Alpharetta, Georgia, USA.
Am J Ophthalmol. 2022 May;237:310-324. doi: 10.1016/j.ajo.2021.10.024. Epub 2021 Nov 3.
To assess the relationship between best-corrected visual acuity (BCVA) and optical coherence tomography (OCT) features in noninfectious uveitis (NIU)-related macular edema.
Clinical cohort study from post hoc analysis of 2 phase 3 clinical trials.
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.
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).
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.
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。
对 2 项 3 期临床试验的事后分析进行临床队列研究。
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。
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)。
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。