Brown David M, Wykoff Charles C, Wong Tien P, Mariani Angeline F, Croft Daniel E, Schuetzle Karri L
Retina Consultants of Houston, Houston Methodist Hospital, Houston, Texas.
Retina. 2014 Sep;34(9):1728-35. doi: 10.1097/IAE.0000000000000191.
To analyze the efficacy and safety of ranibizumab in eyes with preproliferative (ischemic) central retinal vein occlusion.
In this prospective, phase I/II, open-label clinical trial, eyes at high risk of neovascular complications were identified; all eyes met ≥ 3 of 4 high-risk criteria: 1) the best-corrected visual acuity being ≤ 20/200, 2) loss of the 1-2e isopter on Goldmann visual field, 3) relative afferent pupillary defect being ≥ 0.9 log units, and 4) electroretinogram B-wave reduction to ≤ 60% of the corresponding A-wave. Monthly intravitreal ranibizumab treatment for 9 months, monthly monitoring for 3 months, and then monthly examination with pro re nata retreatment on evidence of disease activity for 24 months were performed. Therefore, the total study duration was 36 months.
The main outcome measures were mean change in the best-corrected visual acuity and central macular thickness by optical coherence tomography, proportion of patients with neovascular complications, and the incidence and severity of ocular and nonocular adverse events. Twenty patients were enrolled in the Rubeosis Anti-VEgf trial, and the mean number of intravitreal treatments administered through Months 24 and 36 were 14.1 and 17.2, respectively. The mean best-corrected visual acuity letters gained were +21.1 and +21.4 at 9 and 36 months, respectively. The mean central macular thickness improved -294 μm from baseline after 9 monthly treatments. Subsequently, after 3 months of observation, the mean central macular thickness increased +203 μm. On initiation of pro re nata ranibizumab retreatment, the mean central macular thickness then improved -191 μm at Month 36 compared with Month 12. Nine patients developed neovascular complications, being diagnosed after a mean of 24-month follow-up (range, 3-44 months), with 2 patients developing neovascularization after completion of the 36-month trial endpoint (at Months 42 and 44 after study enrollment).
Intravitreal ranibizumab therapy can improve retinal anatomy and vision in eyes with severe central retinal vein occlusion. Despite significant clinical benefit with antivascular endothelial growth factor therapy, the risk of neovascular complications was not ameliorated by vascular endothelial growth factor blockade, but was merely delayed.
分析雷珠单抗治疗增生前期（缺血性）视网膜中央静脉阻塞患者的疗效和安全性。
在这项前瞻性I/II期开放标签临床试验中，确定具有新生血管并发症高风险的眼；所有眼均符合4项高风险标准中的≥3项：1）最佳矫正视力≤20/200，2）Goldmann视野检查中1-2e等视线缺失，3）相对传入性瞳孔障碍≥0.9对数单位，4）视网膜电图B波降低至相应A波的≤60%。每月玻璃体内注射雷珠单抗治疗9个月，每月监测3个月，然后根据疾病活动证据每月检查并按需进行再治疗，持续24个月。因此，总研究时长为36个月。
主要观察指标为最佳矫正视力的平均变化、光学相干断层扫描测量的中心黄斑厚度、发生新生血管并发症的患者比例以及眼部和非眼部不良事件的发生率和严重程度。20例患者纳入视网膜新生血管抗血管内皮生长因子试验，在第24个月和第36个月时玻璃体内注射治疗的平均次数分别为14.1次和17.2次。在第9个月和第36个月时，最佳矫正视力平均增加的字母数分别为+21.1和+21.4。经过9次每月治疗后，中心黄斑厚度较基线平均改善了-294μm。随后，经过3个月的观察，中心黄斑厚度平均增加了+203μm。在开始按需注射雷珠单抗再治疗后，与第12个月相比，第36个月时中心黄斑厚度平均改善了-191μm。9例患者发生了新生血管并发症，平均随访24个月（范围3-44个月）后确诊，2例患者在36个月试验终点完成后（研究入组后第42个月和第44个月）发生新生血管形成。
玻璃体内注射雷珠单抗治疗可改善重度视网膜中央静脉阻塞患者的视网膜解剖结构和视力。尽管抗血管内皮生长因子治疗具有显著的临床益处，但血管内皮生长因子阻断并不能改善新生血管并发症的风险，只是将其延迟。
