Abstract：
OBJECTIVE: To determine the proportion and characteristics of eyes with neovascular age-related macular degeneration (nAMD) treated with the Port Delivery System (PDS) with ranibizumab that receive supplemental intravitreal ranibizumab injections because of changes in best-corrected visual acuity (BCVA) or central subfield thickness (CST), or both, and to investigate the safety and efficacy of supplemental injections in eyes with the PDS.
METHODS: Post hoc analyses of data from the phase III, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934).
METHODS: Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-VEGF therapy.
METHODS: Four hundred eighteen patients were randomized to the PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab 0.5 mg for 96 weeks.
RESULTS: Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6%-98.4%) did not receive supplemental treatment during each retreatment interval, with 87.4% not receiving supplemental treatment at any point during the trial. Of the 31 eyes receiving supplemental treatment, 58.1% received 1 injection and 32.3% received 2. At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST, 370.5μm vs. 304.4μm; P = 0.0001), subretinal fluid (54.8% vs. 21.2%; P < 0.0001), and larger pigment epithelial detachment height (215.7 μm vs. 175.9 μm; P = 0.003). These features have previously been associated with difficult-to-treat nAMD. Although BCVA and CST generally remained constant throughout the trial in eyes without supplemental treatment, the small number of eyes receiving supplemental treatment on average lost 1 line of vision from baseline to week 96 (mean, -5.7 ETDRS score letters) and CST continued to increase over time. Absolute BCVA at week 96 was similar irrespective of supplemental treatment status (71.1 and 73.7 letters). Best-corrected visual acuity and CST generally improved within 28 days of supplemental treatment.
CONCLUSIONS: Although the PDS Q24W effectively maintains vision and retinal stability in most eyes with nAMD, a small proportion of patients with features of difficult-to-treat nAMD may benefit from supplemental intravitreal anti-VEGF injections and initial close monitoring is recommended.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
METHODS: Post hoc analyses of data from the phase III, randomized, multicenter, open-label, active-comparator Archway trial (NCT03677934).
METHODS: Adults with nAMD diagnosed within 9 months of screening previously responsive to anti-VEGF therapy.
METHODS: Four hundred eighteen patients were randomized to the PDS with ranibizumab 100 mg/ml with fixed refill-exchanges every 24 weeks (Q24W) or monthly intravitreal ranibizumab 0.5 mg for 96 weeks.
RESULTS: Of the 246 eyes treated with the PDS Q24W and assessed for supplemental treatment criteria, the vast majority (94.6%-98.4%) did not receive supplemental treatment during each retreatment interval, with 87.4% not receiving supplemental treatment at any point during the trial. Of the 31 eyes receiving supplemental treatment, 58.1% received 1 injection and 32.3% received 2. At baseline, eyes receiving supplemental treatment were significantly more likely to have thicker retinas (mean CST, 370.5μm vs. 304.4μm; P = 0.0001), subretinal fluid (54.8% vs. 21.2%; P < 0.0001), and larger pigment epithelial detachment height (215.7 μm vs. 175.9 μm; P = 0.003). These features have previously been associated with difficult-to-treat nAMD. Although BCVA and CST generally remained constant throughout the trial in eyes without supplemental treatment, the small number of eyes receiving supplemental treatment on average lost 1 line of vision from baseline to week 96 (mean, -5.7 ETDRS score letters) and CST continued to increase over time. Absolute BCVA at week 96 was similar irrespective of supplemental treatment status (71.1 and 73.7 letters). Best-corrected visual acuity and CST generally improved within 28 days of supplemental treatment.
CONCLUSIONS: Although the PDS Q24W effectively maintains vision and retinal stability in most eyes with nAMD, a small proportion of patients with features of difficult-to-treat nAMD may benefit from supplemental intravitreal anti-VEGF injections and initial close monitoring is recommended.
BACKGROUND: Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.
摘要：
目的：为了确定使用雷珠单抗（PDS）的PortDelivery系统治疗的新生血管性年龄相关性黄斑变性（nAMD）的眼睛的比例和特征，由于最佳矫正视力（BCVA）和/或中央子场厚度（CST）的变化，接受补充玻璃体内注射雷珠单抗。并研究PDS补充注射的安全性和有效性。
方法：对3期随机，多中心，开放标签，主动比较器Archway试验(NCT03677934)。
方法：在筛选之前对抗血管内皮生长因子（抗VEGF）治疗有反应的9个月内诊断出患有nAMD的成年人。
方法：418例患者被随机分配至PDS，使用雷珠单抗100mg/mL，每24周（Q24W）或每月玻璃体内注射雷珠单抗0.5mg，持续96周。
结果：在接受PDSQ24W治疗并评估补充治疗标准的246只眼中，绝大多数（94.6%-98.4%）在每个再治疗间隔期间没有接受补充治疗，87.4%的患者在试验期间的任何时候都没有接受补充治疗。在接受补充治疗的31只眼睛中，58.1%接受1次注射，32.3%接受2次注射。在基线,接受补充治疗的眼睛更可能有更厚的视网膜(平均CST370.5μmvs304.4μm;P=0.0001)，视网膜下液（54.8%vs21.2%；P<0.0001），色素上皮脱离高度较大（215.7μm对175.9μm；P=0.003）。这些特征以前与难以治疗的nAMD有关。而BCVA和CST在没有补充治疗的情况下在整个试验中通常保持不变，从基线至第96周,接受补充治疗的少量眼睛平均失去1行视力(平均-5.7早期治疗糖尿病视网膜病变研究评分字母),CST随时间持续增加.无论补充治疗状态如何，第96周的绝对BCVA相似（71.1和73.7字母）。BCVA和CST通常在补充治疗的28天内得到改善。
结论：尽管PDSQ24W能有效维持大多数nAMD患者的视力和视网膜稳定性，一小部分具有难以治疗的nAMD特征的患者可能会从玻璃体内注射抗VEGF的补充治疗中获益,因此建议进行早期密切监测.
方法：对3期随机，多中心，开放标签，主动比较器Archway试验(NCT03677934)。
方法：在筛选之前对抗血管内皮生长因子（抗VEGF）治疗有反应的9个月内诊断出患有nAMD的成年人。
方法：418例患者被随机分配至PDS，使用雷珠单抗100mg/mL，每24周（Q24W）或每月玻璃体内注射雷珠单抗0.5mg，持续96周。
结果：在接受PDSQ24W治疗并评估补充治疗标准的246只眼中，绝大多数（94.6%-98.4%）在每个再治疗间隔期间没有接受补充治疗，87.4%的患者在试验期间的任何时候都没有接受补充治疗。在接受补充治疗的31只眼睛中，58.1%接受1次注射，32.3%接受2次注射。在基线,接受补充治疗的眼睛更可能有更厚的视网膜(平均CST370.5μmvs304.4μm;P=0.0001)，视网膜下液（54.8%vs21.2%；P<0.0001），色素上皮脱离高度较大（215.7μm对175.9μm；P=0.003）。这些特征以前与难以治疗的nAMD有关。而BCVA和CST在没有补充治疗的情况下在整个试验中通常保持不变，从基线至第96周,接受补充治疗的少量眼睛平均失去1行视力(平均-5.7早期治疗糖尿病视网膜病变研究评分字母),CST随时间持续增加.无论补充治疗状态如何，第96周的绝对BCVA相似（71.1和73.7字母）。BCVA和CST通常在补充治疗的28天内得到改善。
结论：尽管PDSQ24W能有效维持大多数nAMD患者的视力和视网膜稳定性，一小部分具有难以治疗的nAMD特征的患者可能会从玻璃体内注射抗VEGF的补充治疗中获益,因此建议进行早期密切监测.
