玻璃体腔内注射阿柏西普治疗糖尿病性视网膜病变严重程度评分持续改善的功能结局：VISTA 和 VIVID 试验。
Functional outcomes of sustained improvement on Diabetic Retinopathy Severity Scale with intravitreal aflibercept in the VISTA and VIVID trials.
机构信息
California Retina Consultants/Retina Consultants of America, Santa Barbara, CA, USA.
Regeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
出版信息
Eye (Lond). 2023 Jul;37(10):2020-2025. doi: 10.1038/s41433-022-02058-7. Epub 2022 Apr 19.
AIMS
To assess time to, cumulative incidence of, and functional benefit of achieving sustained ≥2-step Diabetic Retinopathy Severity Scale (DRSS) improvement in diabetic macular oedema (DMO).
METHODS
Post hoc analysis of VISTA/VIVID including eyes with DMO treated with intravitreal aflibercept injections (IAI), 2 mg q4 weeks (2q4, n = 250) or q8 weeks after 5 monthly doses (2q8, n = 249), or laser control (n = 249). Changes from baseline in best-corrected visual acuity (BCVA) and central subfield thickness (CST) were evaluated in sustained (≥2 consecutive visits) DRSS subgroups (≥1-step worsening, no change, ≥2-step improvement).
RESULTS
Time to sustained ≥2-step DRSS improvement was shorter for both the IAI 2q4 and IAI 2q8 groups versus laser (both log-rank p < 0.001). Cumulative incidences of sustained ≥2-step DRSS improvement with IAI 2q4 and IAI 2q8 versus laser were 40.0% and 42.8% versus 15.5% (both p < 0.001) through week 100. Mean differences (95% CI) in BCVA gains from baseline at weeks 52 and 100 between eyes with sustained ≥2-step DRSS improvement versus sustained ≥1-step DRSS worsening were -3.0 (-8.9, 2.9) and 6.2 (0.2, 12.2) letters with laser, and 4.2 (0.8, 7.6) and 4.9 (1.3, 8.4) letters with IAI combined, respectively. Difference (95% CI) in CST reduction was significantly greater only with IAI combined at week 100 (-83.0 [-140.8, -25.3]). Correlations between BCVA and CST changes were weak.
CONCLUSIONS
DMO eyes treated with IAI achieved sustained ≥2-step DRSS improvement significantly earlier and more frequently versus laser. This improvement was associated with greater BCVA gains, independent of CST reductions.
TRIAL REGISTRATION
ClinicalTrials.gov ( https://clinicaltrials.gov/ ) identifiers: NCT01363440 and NCT01331681 .
目的
评估糖尿病性黄斑水肿（DMO）患者接受玻璃体内注射阿柏西普（IAI）治疗后达到持续≥2 步糖尿病视网膜病变严重程度量表（DRSS）改善的时间、累积发生率和功能获益。
方法
VISTA/VIVID 的事后分析包括接受 IAI 2mg，每 4 周（2q4，n=250）或每 8 周（2q8，n=249）治疗或激光对照治疗（n=249）的 DMO 眼。评估持续（≥2 次连续就诊）DRSS 亚组（≥1 步恶化、无变化、≥2 步改善）中最佳矫正视力（BCVA）和中心凹下视网膜厚度（CST）从基线的变化。
结果
与激光相比，IAI 2q4 和 IAI 2q8 组达到持续≥2 步 DRSS 改善的时间更短（均对数秩检验 p<0.001）。IAI 2q4 和 IAI 2q8 与激光相比，持续≥2 步 DRSS 改善的累积发生率分别为 40.0%和 42.8%，而激光为 15.5%（均 p<0.001），至第 100 周。与持续≥1 步 DRSS 恶化相比，持续≥2 步 DRSS 改善的眼在第 52 周和第 100 周时从基线的 BCVA 增益的平均差异（95%CI）分别为激光治疗组-3.0（-8.9，2.9）和 6.2（0.2，12.2）个字母，IAI 联合治疗组为 4.2（0.8，7.6）和 4.9（1.3，8.4）个字母。仅在 IAI 联合治疗时，第 100 周的 CST 降低差异（95%CI）有统计学意义，为-83.0（-140.8，-25.3）。BCVA 和 CST 变化之间的相关性较弱。
结论
与激光相比，接受 IAI 治疗的 DMO 眼更早且更频繁地达到持续≥2 步 DRSS 改善。这种改善与 BCVA 的提高有关，与 CST 的降低无关。
临床试验注册
ClinicalTrials.gov（https://clinicaltrials.gov/）标识符：NCT01363440 和 NCT01331681。
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