Kaiser Peter K, Singer Michael, Tolentino Michael, Vitti Robert, Erickson Kristine, Saroj Namrata, Berliner Alyson J, Chu Karen W, Zhu Xiaoping, Williams Liu Zinaria, Clark W Lloyd
Cole Eye Institute, Cleveland, Ohio.
Medical Center Ophthalmology Associates, San Antonio, Texas.
Ophthalmol Retina. 2017 Jul-Aug;1(4):304-313. doi: 10.1016/j.oret.2017.01.004. Epub 2017 Mar 18.
To assess the long-term safety and vision change in patients who received intravitreal aflibercept injection (IAI) for neovascular age-related macular degeneration in an extension study after completing VIEW 1 trial.
Prospective, open-label, multicenter, extension study.
Three hundred twenty-three patients.
In VIEW 1, 1217 patients were randomized to receive fixed dosing of 0.5 mg IAI every 4 weeks (0.5q4), 2 mg IAI every 4 weeks (2q4), 2 mg IAI every 8 weeks after 3 initial monthly dosing (2q8), or 0.5 mg ranibizumab every 4 weeks (Rq4) from baseline through week 52, followed by modified quarterly injections of the same dose of anti-vascular endothelial growth factor agent from weeks 52 to 96. After completing VIEW 1 at week 96, patients (n = 323) enrolled in an extension study and received 2 mg IAI on a modified quarterly injection schedule followed by at least an every 8-week dosing through week 212.
Long-term safety and vision change in patients followed for a median duration of 116 weeks in the extension study (total follow-up time of 212 weeks from the VIEW 1 baseline).
Patients enrolled in the extension study gained a mean of 10.2 letters from the VIEW 1 baseline at week 96. These patients largely maintained vision over the extension study with a mean gain of 7.1 letters from the VIEW 1 baseline to week 212. The proportion of patients who lost ≥15 letters from the VIEW 1 extension baseline was 8.2% at week 212. Mean number of injections was 12.9 (range, 1-41) in the extension study. The most common serious ocular adverse event was endophthalmitis (0.9%). The overall incidence of Antiplatelet Trialists' Collaboration-defined arterial thromboembolic events was 6.2%.
Vision gains achieved with anti-vascular endothelial growth factor therapy in VIEW 1 were largely maintained by continued treatment with IAI 2 mg in the extension study. Anti-vascular endothelial growth factor injections (including 4 years of IAI 2 mg) were well-tolerated with no new safety signals compared with the known profile of IAI.
在完成VIEW 1试验后的一项扩展研究中，评估接受玻璃体内注射阿柏西普（IAI）治疗新生血管性年龄相关性黄斑变性患者的长期安全性和视力变化。
前瞻性、开放标签、多中心扩展研究。
323例患者。
在VIEW 1试验中，1217例患者被随机分组，从基线至第52周，分别接受每4周一次0.5 mg IAI固定剂量注射（0.5q4）、每4周一次2 mg IAI注射（2q4）、初始每月注射3次后每8周一次2 mg IAI注射（2q8）或每4周一次0.5 mg雷珠单抗注射（Rq4），随后从第52周至第96周每季度注射相同剂量的抗血管内皮生长因子药物。在第96周完成VIEW 1试验后，323例患者进入扩展研究，接受改良的每季度一次2 mg IAI注射，随后至少每8周注射一次，直至第212周。
在扩展研究中对患者进行为期116周的中位随访（从VIEW 1基线开始的总随访时间为212周），观察其长期安全性和视力变化。
进入扩展研究的患者在第96周时，较VIEW 1基线平均视力提高了10.2个字母。在扩展研究期间，这些患者的视力基本保持稳定，从VIEW 1基线至第212周平均提高了7.1个字母。在第212周时，较VIEW 1扩展基线视力下降≥15个字母的患者比例为8.2%。扩展研究中平均注射次数为12.9次（范围为1 - 41次）。最常见的严重眼部不良事件是眼内炎（0.9%）。抗血小板试验协作组定义的动脉血栓栓塞事件的总体发生率为6.2%。
在扩展研究中，通过继续使用2 mg IAI治疗，很大程度上维持了VIEW 1试验中抗血管内皮生长因子治疗所取得的视力提高。与已知的IAI情况相比，抗血管内皮生长因子注射（包括4年的2 mg IAI）耐受性良好，未出现新的安全信号。
