Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration in Vulnerable Fellow Eyes
Prophylactic Ranibizumab to Prevent Neovascular Age-Related Macular Degeneration in Vulnerable Fellow Eyes
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DOI：
10.1016/j.oret.2022.01.019
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发表时间：
2022-06-06
影响因子：
4.5
通讯作者：
Yiu, Glenn
中科院分区：
文献类型：
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作者：
Chan, Clement K.;Lalezary, Maziar;Yiu, Glenn
目的：探讨预防性应用雷尼比单抗能否预防患中年龄相关性黄斑变性(AMD)患者对侧眼新生血管性老年性黄斑变性(NAMD)的发生。设计：多中心随机临床试验。参与者：50岁及以上的成年人，研究眼有中度AMD(63 mm和1个大的色素变性)，对侧眼有NAMD。干预：玻璃体腔内注射雷尼比单抗(0.5 mg)或假注射，持续24个月。主要观察指标：转为NAMD超过24个月。结果：108名受试者中，除2名外，其余均为非西班牙裔白人，61名受试者为女性(56%)，平均年龄为78岁。平均基线视力为77.7个字母(相当于Snellen的20/32)。两组54只眼中有7只眼(13%)在24个月后转为NAMD(雷尼比单抗与假手术的危险比=0.91[95%可信区间(CI)0.32~2.59]；P=0.86)。在24个月时，经失访调整后的NAMD累积发生率雷尼比单抗组为14%(95%可信区间，4%-23%)，假手术组为15%(95%可信区间，4%-25%)。24个月时，雷尼比珠单抗的平均视力变化为-2.1个字母(标准差，5.4个字母)，而假手术组的平均视力变化为-1.4个字母(标准差，7.7个字母)(调整后的差值=-0.8个字母[95%CI，-3.7至2.2个字母]；P=0.62)。在24个月时，服用雷尼比单抗的39只眼中，视力下降至少10个字母的比例为2/39(5%)，而服用假手术的40只眼中，有4只眼(10%)视力下降。两组患者均未发生严重的眼部不良事件。结论：与假注射相比，中度AMD患者每季度注射0.5 mg雷尼比珠单抗并不能降低NAMD的发生率；然而，考虑到95%的可信区间，这项研究可能存在动力不足，不能排除临床上有意义的效果。在24个月时，对视力也没有影响。需要其他策略来减少这些脆弱眼睛的新生血管转化。眼科视网膜2022；6：484-4942022，美国眼科学会
Purpose: To determine whether prophylactic ranibizumab prevents the development of neovascular age-related macular degeneration (nAMD) in eyes with intermediate age-related macular degeneration (AMD) for patients with preexisting nAMD in their contralateral eye. Design: Multicenter randomized clinical trial.Participants: Adults aged 50 years and older with intermediate AMD (multiple intermediate drusen [>63 mm and 1 large drusen [>125 mm] and pigmentary changes) in the study eye and nAMD in the contralateral eye.Intervention: Intravitreal ranibizumab injection (0.5 mg) or sham injection every 3 months for 24 months.Main Outcome Measures: Conversion to nAMD over 24 months (primary). Change in best-corrected visual acuity from baseline to 24 months (secondary).Results: Among 108 enrolled participants (54 [50%] in each group), all except 2 were non-Hispanic Whites, 61 participants (56%) were female, and the mean age was 78 years. The mean baseline visual acuity was 77.7 letters (Snellen equivalent 20/32). Conversion to nAMD over 24 months occurred among 7 of 54 eyes (13%) in both groups (ranibizumab vs. sham hazard ratio = 0.91 [95% confidence interval (CI), 0.32-2.59]; P = 0.86). At 24 months, the cumulative incidence of nAMD adjusted for loss to follow-up was 14% (95% CI, 4%-23%) in the ranibizumab group and 15% (95% CI, 4%-25%) in the sham group. At 24 months, the mean change in visual acuity from baseline was-2.1 letters (standard deviation, 5.4 letters) with ranibizumab and-1.4 letters (standard deviation, 7.7 letters) with sham (adjusted difference =-0.8 letters [95% CI,-3.7 to 2.2 letters]; P = 0.62). The proportion of eyes that lost at least 10 letters of visual acuity from baseline at 24 months was 2 of 39 (5%) with ranibizumab and 4 of 40 (10%) with sham. There were no serious ocular adverse events in either group.Conclusions: Quarterly dosing of 0.5 mg ranibizumab in eyes with intermediate AMD did not reduce the incidence of nAMD compared with sham injections; however, the study was likely underpowered given the 95% CI, and a clinically meaningful effect cannot be excluded. There also was no effect on visual acuity at 24 months. Other strategies to reduce neovascular conversion in these vulnerable eyes are needed. Ophthalmology Retina 2022;6:484-494 2022 by the American Academy of Ophthalmology