BACKGROUND To evaluate the efficacy and safety of two individualized ranibizumab retreatment schemes in neovascular age-related macular degeneration. METHODS Patients (N = 671) were randomized (1:1) to receive three initial monthly ranibizumab 0.5 mg injections, then retreatment guided by either best-corrected visual acuity (BCVA) loss (Group I) or BCVA loss and/or signs of disease activity on optical coherence tomography (OCT; Group II). The study was terminated prematurely and the decision to discontinue the study was made by the sponsor. Efficacy analyses were performed on patients who completed 12 months of the originally planned 24-month study. Safety analyses are presented for all safety analyzable patients. RESULTS Of 671 randomized patients, 305 completed 12 months of the study. For the 12-month completers, baseline mean (standard deviation) BCVA and reading-center evaluated central subfield thickness (CSFT) were comparable [Group I: 60.9 (13.10) letters and 517.7(201.79) μm; Group II: 60.2 (12.21) letters and 515.3 (198.37) μm]. The change from baseline at Month 12 in BCVA was 6.7 (13.48) letters in Group I and 8.3 (13.53) letters in Group II and the change in CSFT was - 161.3 (163.48) μm and - 175.3 (170.45) μm, respectively. The mean number of ranibizumab injections was 8.2 in Group I and 8.4 in Group II. CONCLUSION Ranibizumab treatment resulted in visual and anatomic gains at 12 months for both retreatment strategies, with a trend in favor of OCT-guided vs BCVA loss guided retreatment. No new safety signals were seen. TRIAL REGISTRATION www.ClinicalTrials.gov (NCT01780935). Registered 31 January 2013.

中文翻译：

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在新生血管性年龄相关性黄斑变性患者中应用功能，功能和解剖学标准指导的兰尼单抗治疗-来自随机IIIb OCTAVE研究的结果。

背景技术为评估两种个体化兰尼单抗再治疗方案在新生血管性年龄相关性黄斑变性中的疗效和安全性。方法（N = 671）患者被随机分配（1：1）接受三个月度雷珠单抗初始0.5 mg注射，然后在最佳矫正视力（BCVA）丧失（I组）或BCVA丧失和/或体征的指导下进行再治疗相干断层扫描（OCT；第二组）的疾病活动。该研究过早终止，申办者决定终止研究。对完成了原计划的24个月研究的12个月的患者进行了功效分析。针对所有可分析安全性的患者进行了安全性分析。结果在671名随机分组的患者中，有305名完成了12个月的研究。对于12个月的完成者，基线均值（标准差）BCVA和阅读中心评估的中心子场厚度（CSFT）相当[第一组：60.9（13.10）个字母和517.7（201.79）μm；第二组：60.2（12.21）个字母和515.3（198.37）μm]。BCVA在第12个月从基线的变化是I组的6.7（13.48）个字母和II组的8.3（13.53）个字母，CSFT的变化分别是-161.3（163.48）μm和-175.3（170.45）μm。第一组兰尼单抗的平均注射数为8.2，第二组为8.4。结论雷尼单抗治疗在两种治疗策略中均在12个月时获得了视觉和解剖学上的益处，并且倾向于OCT引导与BCVA丢失引导的治疗。没有看到新的安全信号。试用注册www.ClinicalTrials.gov（NCT01780935）。2013年1月31日注册。