Nguyen Vuong, Vaze Anagha, Fraser-Bell Samantha, Arnold Jennifer, Essex Rohan W, Barthelmes Daniel, Gillies Mark C
Save Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, Sydney, Australia.
Save Sight Institute, Discipline of Ophthalmology, Sydney Medical School, The University of Sydney, Sydney, Australia.
Ophthalmol Retina. 2019 Aug;3(8):623-628. doi: 10.1016/j.oret.2019.05.013. Epub 2019 May 17.
Currently, little evidence supports the safety of suspending vascular endothelial growth factor (VEGF) inhibitors for neovascular age-related macular degeneration (nAMD). We assessed the outcomes of eyes in which this seems to have been attempted.
Observational study from a prospectively designed database.
Eyes enrolled in the Fight Retinal Blindness! registry of nAMD treatment outcomes were considered to have suspended treatment if they had a 3-month or longer documented period of inactivity of the choroidal neovascular lesion with no further treatments unless the lesion re-activated.
Time and proportion to re-activation of the lesion were analyzed using Kaplan-Meier survival curves. Visual outcomes after treatment suspension were assessed with paired t tests.
The proportion of eyes resuming treatment because of lesion re-activation, change in visual acuity (VA) at time of re-activation, and recovery of vision 12 months later.
We identified 434 eyes in which treatment was suspended and that were tracked for at least 12 months thereafter. The estimated percentage of eyes re-activating in the first year after treatment suspension was 41%, increasing to 79% by the fifth year. The median time to re-activation was 504 days. The 275 eyes whose lesion was observed to re-activate lost a mean of 4.2 letters (95% confidence interval [CI], -5.6 to -2.8 letters; P < 0.001) from the last injection to the time of re-activation; 206 eyes resumed treatment for at least 12 months after re-activation and recovered a mean of +1.2 letters (95% CI, -0.4 to 2.7 letters; P = 0.133), resulting in a net loss of 3.3 letters (95% CI, 2.3-5.1 letters; P < 0.001) compared with VA at treatment suspension. Lower VA at the time of suspension and longer duration of treatment were associated with reduced risk of re-activation. Median time to re-activation was substantially greater when eyes had been treated for at least 3 years.
Fewer than half of the eyes in which treatment was suspended re-activated in the first year, but most re-activated by the fifth year. Caution should be exercised to avoid suspending treatment prematurely. Further research is warranted to identify the eyes in which treatment may be suspended safely.
目前,几乎没有证据支持暂停血管内皮生长因子(VEGF)抑制剂治疗新生血管性年龄相关性黄斑变性(nAMD)的安全性。我们评估了那些似乎尝试过这种做法的眼睛的治疗结果。
来自前瞻性设计数据库的观察性研究。
纳入“抗击视网膜失明!”nAMD治疗结果登记处的眼睛,如果脉络膜新生血管病变有3个月或更长时间记录在案的静止期,且在病变重新激活之前没有进一步治疗,则被视为已暂停治疗。
使用Kaplan-Meier生存曲线分析病变重新激活的时间和比例。使用配对t检验评估治疗暂停后的视力结果。
因病变重新激活而恢复治疗的眼睛比例、重新激活时的视力(VA)变化以及12个月后的视力恢复情况。
我们确定了434只暂停治疗的眼睛,并在之后至少跟踪了12个月。治疗暂停后第一年病变重新激活的估计眼睛百分比为41%,到第五年增加到79%。重新激活的中位时间为504天。观察到病变重新激活的275只眼睛从最后一次注射到重新激活时平均视力下降了4.2个字母(95%置信区间[CI],-5.6至-2.8个字母;P<0.001);206只眼睛在重新激活后恢复治疗至少12个月,平均视力恢复了+1.2个字母(95%CI,-0.4至2.7个字母;P=0.133),与治疗暂停时的视力相比,净下降了3.3个字母(95%CI,2.3 - 5.1个字母;P<0.001)。暂停治疗时较低的视力和较长的治疗持续时间与重新激活风险降低相关。当眼睛接受治疗至少3年时,重新激活的中位时间显著更长。
治疗暂停的眼睛中,不到一半在第一年重新激活,但到第五年大多数重新激活。应谨慎避免过早暂停治疗。有必要进行进一步研究以确定哪些眼睛可以安全地暂停治疗。