Long-term Outcomes in Patients with Retinal Vein Occlusion Treated with Ranibizumab The RETAIN Study
Long-term Outcomes in Patients with Retinal Vein Occlusion Treated with Ranibizumab The RETAIN Study
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DOI：
10.1016/j.ophtha.2013.08.038
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发表时间：
2014-01-01
期刊：
影响因子：
13.7
通讯作者：
Patel, Arun
中科院分区：
文献类型：
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作者：
Campochiaro, Peter A.;Sophie, Raafay;Patel, Arun
目的：设计：前瞻性随访2个3期临床试验的一部分患者。参与者：34名分支视网膜静脉阻塞（BRVO）患者和32名中央视网膜静脉阻塞（CRVO）患者，他们完成了Genentech赞助的雷珠单抗研究RVO试验。方法：第1年每个月和第2年至少每3个月观察一次的患者接受雷珠单抗治疗视网膜内积液。需要注射的患者在连续visits.Main结果测量：平均改善最佳矫正视力（BCVA）和水肿resolution.Results的患者的百分比：平均随访49.0个月，17 34 BRVO患者（50%）水肿分辨率定义为没有视网膜内液体6个月或以上后，最后一次注射。76%的患者在治疗开始后2年内接受了末次注射。第4年未消退患者所需的平均注射次数为3.2次。水肿消退患者的BCVA平均改善为25.9个字母，而未消退患者的BCVA平均改善为17.1个字母（P 0.09），两组中，约80%的最终BCVA为20/40或更好。平均随访49.7个月，32例CRVO患者中有14例（44%）水肿消退，71%的患者在治疗开始后2年内接受了最后一次注射。第4年未消退患者的平均注射次数为5.9次。与CRVO未消退患者相比，疾病消退患者的BCVA改善更大（25.2 vs. 4.3个字母; P 0.002），最终BCVA为20/40或更好的百分比更高（64.3% vs. 27.8%; P 0.04）。9例BRVO和9例CRVO接受散射光凝，平均随访9个月（BRVO）和11个月（CRVO）后，最后一个激光，只有1在每组有决议的水肿。结论：长期的结果在BRVO患者治疗与雷珠单抗是优秀的，虽然一半仍然需要偶尔注射后4年，他们保持良好的视觉潜力。雷珠单抗治疗的CRVO患者中有相当一部分（44%）在4年内水肿消退且结局良好，但大多数（56%）仍需要频繁注射，视力下降，预后良好。Ophthalmology 2014; 121：209-219（C）2014，美国眼科学会。
Objective: To determine long-term outcomes of patients with ranibizumab-treated retinal vein occlusion (RVO).Design: Prospective follow-up of a subset of patients from 2 phase 3 trials.Participants: Thirty-four patients with branch RVO (BRVO) and 32 with central RVO (CRVO) who completed the Genentech-sponsored ranibizumab study RVO trials.Methods: Patients seen every month in year 1 and at least every 3 months in year 2 were treated with ranibizumab for intraretinal fluid. Patients requiring injections on consecutive visits were treated with ranibizumab plus scatter photocoagulation.Main Outcome Measures: Mean improvement in best-corrected visual acuity (BCVA) and percentage of patients with edema resolution.Results: With a mean follow-up of 49.0 months, 17 of 34 BRVO patients (50%) had edema resolution defined as no intraretinal fluid for 6 months or more after the last injection. The last injection was given within 2 years of treatment initiation in 76%. The mean number of injections required in unresolved patients in year 4 was 3.2. In patients with resolved edema mean improvement in BCVA was 25.9 letters versus 17.1 letters (P 0.09) in unresolved patients, and in both groups, approximately 80% had a final BCVA of 20/40 or better. With a mean follow-up of 49.7 months, 14 of 32 CRVO patients (44%) had edema resolution, with 71% receiving their last injection within 2 years of treatment initiation. The mean number of injections in unresolved patients in year 4 was 5.9. Compared with patients with unresolved CRVO, patients with resolved disease had greater improvement in BCVA (25.2 vs. 4.3 letters; P 0.002), and a greater percentage had a final BCVA of 20/40 or better (64.3% vs. 27.8%; P 0.04). Nine patients with BRVO and 9 with CRVO received scatter photocoagulation, and with mean follow-up of 9 months (BRVO) and 11 months (CRVO) after last laser, only 1 in each group had resolution of edema.Conclusions: Long-term outcomes in BRVO patients treated with ranibizumab were excellent, and although half still required occasional injections after 4 years, they maintained good visual potential. A substantial minority (44%) of patients with ranibizumab-treated CRVO had edema resolution and a good outcome within 4 years, but most (56%) still required frequent injections, had reduced visual potential, and have a guarded prognosis. Ophthalmology 2014; 121: 209-219 (C) 2014 by the American Academy of Ophthalmology.