Department of Ophthalmology, Flor Ferenc Hospital of Pest County, Kistarcsa, Hungary.
Department of Ophthalmology, Semmelweis University, Maria u. 39, Budapest, H-1085, Hungary.
BMC Ophthalmol. 2023 Mar 17;23(1):110. doi: 10.1186/s12886-023-02843-2.
BACKGROUND: Anti-vascular endothelial growth factor (VEGF) therapy is currently the most effective therapy of exudative age-related macular degeneration (AMD). The aim of this study was to assess long-term benefits of intensive aflibercept and ranibizumab anti-VEGF therapy in patients with exudative AMD. METHODS: Two clinical trial sites recruited their original subjects for a re-evaluation 7 years after the baseline visit of the phase-3 Vascular Endothelial Growth Factor (VEGF) Trap-Eye: Investigation of Efficacy and Safety in Wet Age-Related Macular Degeneration (VIEW 2) trial. Forty-seven eyes of 47 patients with AMD originally treated with ranibizumab (14 eyes) or aflibercept (33 eyes) were included. RESULTS: Mean number of injections was 17.8 ± 3.0 during participation in the VIEW 2 trial. Fourteen of 47 (30%) eyes were given additional injections with a mean number of 5.7 ± 4.5 after the trial. At a mean follow-up time of 82 ± 5 months best corrected visual acuity (BCVA) remained stable or improved (≤ 10 letters lost) in 55% of patients in the entire study population, in 43% in the ranibizumab group and in 60% in the aflibercept group. In both groups combined mean BCVA was 54 ± 13 letters at baseline, 65 ± 17 letters at the end of the intensive phase and 45 ± 25 letters at the end of follow-up. There was no statistically significant difference in BCVA between the two groups at baseline (p = 0.88) and at the end of follow-up (p = 0.40). Macular atrophy was observed in 96% of eyes, average area was 7.22 ± 6.31 mm with no statistically significant difference between groups (p = 0.47). Correlation between BCVA at end-of-follow-up and the area of atrophy was significant (p < 0.001). At the end of follow-up, fluid was detected in 7 of 47 eyes (15%) indicating disease activity. CONCLUSION: Long-term efficacy of aflibercept and ranibizumab was largely consistent. Following a two-year intensive therapy with as-needed regimen, BCVA was maintained or improved in almost half of the patients and in the ranibizumab group and more than half of the patients in the aflibercept group with very few injections. In a remarkable proportion of eyes, BCVA declined severely which underlines the need for long-term follow-ups and may indicate a more prolonged intensive therapy. TRIAL REGISTRATIONS: VIEW 2 study: ClinicalTrials.gov ID: NCT00637377, date of registration: March 18, 2008. Long-term follow-up: IRB nr.: SE RKEB 168/2022, ClinicalTrials.gov ID: NCT05678517, date of registration: December 28, 2022, retrospectively registered.
背景:抗血管内皮生长因子(VEGF)治疗是目前治疗渗出性年龄相关性黄斑变性(AMD)最有效的方法。本研究旨在评估密集型阿柏西普和雷珠单抗抗 VEGF 治疗对渗出性 AMD 患者的长期疗效。
方法:两个临床试验点在基线访视后 7 年重新评估了三期血管内皮生长因子(VEGF)陷阱眼:湿性年龄相关性黄斑变性(AMD)疗效和安全性的研究(VIEW 2 试验)的原始受试者。共纳入 47 例 AMD 患者的 47 只眼,最初接受雷珠单抗(14 只眼)或阿柏西普(33 只眼)治疗。
结果:在 VIEW 2 试验中,平均注射次数为 17.8±3.0 次。试验结束后,有 14 只眼(30%)额外接受了注射,平均注射次数为 5.7±4.5 次。在平均 82±5 个月的随访时间内,整个研究人群中 55%的患者最佳矫正视力(BCVA)保持稳定或改善(≤10 个字母丢失),在雷珠单抗组中为 43%,在阿柏西普组中为 60%。两组联合治疗的基线时平均 BCVA 为 54±13 个字母,强化期结束时为 65±17 个字母,随访结束时为 45±25 个字母。两组在基线时(p=0.88)和随访结束时(p=0.40)的 BCVA 无统计学差异。96%的眼观察到黄斑萎缩,平均面积为 7.22±6.31mm,两组间无统计学差异(p=0.47)。BCVA 与萎缩面积之间存在显著相关性(p<0.001)。随访结束时,47 只眼中有 7 只(15%)发现有液体积聚,表明疾病活动。
结论:阿柏西普和雷珠单抗的长期疗效基本一致。在为期两年的密集治疗和按需治疗方案后,近一半的患者和阿柏西普组中超过一半的患者的 BCVA 保持或改善,且注射次数非常少。在很大一部分眼中,BCVA 严重下降,这强调了需要长期随访,并可能表明需要更长期的密集治疗。
试验注册:VIEW 2 研究:ClinicalTrials.gov ID:NCT00637377,注册日期:2008 年 3 月 18 日。长期随访:IRB nr.:SE RKEB 168/2022,ClinicalTrials.gov ID:NCT05678517,注册日期:2022 年 12 月 28 日,回顾性注册。
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