Taipei City Hospital, Taipei City, Taiwan.
Institute of Public Health, National Yang Ming Chiao Tung University, Taipei City, Taiwan.
BMC Ophthalmol. 2023 Jan 27;23(1):39. doi: 10.1186/s12886-023-02780-0.
BACKGROUND: The Ranibizumab AMD Clinical Efficacy Study (RACER) conducted in treatment-naive adult Taiwanese patients with neovascular age-related macular degeneration (nAMD) suggested the importance of early and intensive dosing of ranibizumab for optimal treatment outcomes. This subgroup analysis aims to provide clinical information on treatment response that can potentially guide on maintaining the treatment or switching anti-VEGF agents in the real-world setting. METHODS: Visual acuity (VA) and central retinal thickness (CRT) were assessed in the RACER subgroup population. Subgroup analysis sets were categorised based on: (1) baseline best-corrected VA (BCVA; ≤ 48 and > 48 letters); (2) baseline CRT (≤ 325 or > 325 μm); and (3) treatment response after three monthly initial injections: < or ≥ 5-letter gain in BCVA and reduction of < or ≥ 50 μm in CRT. RESULTS: Patient age, sex, nAMD duration and number of ranibizumab injections did not differ significantly between the treatment subgroups. Poor baseline BCVA (≤ 48 letters) and baseline CRT severity (> 325 µm) were predictors of maximum BCVA gains (9.6 ± 12.9 letters [95%CI: 6.3 to 12.9] and 5.1 ± 18.3 letters [95%CI: - 0.5 to 10.8] at Months 3 and 12, respectively) and better CRT reductions (- 127.6 ± 104.2 µm and - 104.2 ± 107.4 µm at Months 3 and 12, respectively; both P < 0.001). For the subgroup showing favourable treatment improvement with BCVA gains ≥ 5 letters after three monthly initial injections, 75.6% of patients maintained follow-up at Month 12 with a mean of 6.5 ± 14.3 letter gains (95% CI: 1.2 to 11.7). The BCVA gains < 5-letter subgroup nevertheless had stable BCVA (0.4 ± 12.1 letter gains) and CRT (- 41.9 ± 61.2 µm) at Month 12, respectively. In the subgroup with ≥ 50 µm CRT reduction after three monthly initial injections, there are significantly higher BCVA improvements vs. the < 50 µm CRT reduction subgroup at Month 3 (5.0 ± 8.6 letter gains vs. 1.5 ± 11.6 letter gains, respectively; intergroup P = 0.005). CONCLUSION: Lower baseline BCVA and higher baseline CRT were associated with BCVA gains and CRT reductions throughout the 12-month study period. Early CRT improvements after three monthly initial injections were associated with BCVA gains as early as Month 3.
背景：在接受雷珠单抗 AMD 临床疗效研究（RACER）治疗的未经治疗的成年台湾新血管性年龄相关性黄斑变性（nAMD）患者中，雷珠单抗的早期和强化给药对于获得最佳治疗效果非常重要。本次亚组分析旨在提供可能有助于指导实际治疗中维持治疗或转换抗 VEGF 药物的治疗反应的临床信息。
方法：在 RACER 亚组人群中评估视力（VA）和中心视网膜厚度（CRT）。亚组分析集根据以下三个方面进行分类：（1）基线最佳矫正视力（BCVA；≤48 和>48 字母）；（2）基线 CRT（≤325 或>325 μm）；（3）三次初始每月注射后的治疗反应：BCVA 增加<5 或≥5 个字母和 CRT 减少<50 μm 或≥50 μm。
结果：治疗亚组之间患者年龄、性别、nAMD 持续时间和雷珠单抗注射次数无显著差异。基线 BCVA 较差（≤48 个字母）和基线 CRT 严重程度较高（>325 μm）是最大 BCVA 增益（第 3 个月和第 12 个月分别为 9.6±12.9 个字母[95%CI：6.3 至 12.9]和 5.1±18.3 个字母[95%CI：-0.5 至 10.8]）和 CRT 改善（第 3 个月和第 12 个月分别为-127.6±104.2 μm 和-104.2±107.4 μm；均 P<0.001）的预测因素。对于在三次初始每月注射后 BCVA 增加≥5 个字母的治疗改善亚组，75.6%的患者在第 12 个月时继续随访，平均 BCVA 增加 6.5±14.3 个字母（95%CI：1.2 至 11.7）。然而，BCVA 增加<5 个字母的亚组在第 12 个月时仍保持稳定的 BCVA（0.4±12.1 个字母增加）和 CRT（-41.9±61.2 μm）。在三次初始每月注射后 CRT 减少≥50 μm 的亚组中，与 CRT 减少<50 μm 的亚组相比，第 3 个月时 BCVA 改善更为显著（分别为 5.0±8.6 个字母增加和 1.5±11.6 个字母增加；组间 P=0.005）。
结论：较低的基线 BCVA 和较高的基线 CRT 与整个 12 个月研究期间的 BCVA 增益和 CRT 减少相关。三次初始每月注射后早期 CRT 改善与第 3 个月时的 BCVA 改善有关。
J Formos Med Assoc. 2021-12
Graefes Arch Clin Exp Ophthalmol. 2021-8
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