Pieramici Dante, Singh Rishi P, Gibson Andrea, Saroj Namrata, Vitti Robert, Berliner Alyson J, Zeitz Oliver, Metzig Carola, Soo Yuhwen, Zhu Xiaoping, Boyer David S
California Retina Consultants, Santa Barbara, California.
Cole Eye Institute, Department of Ophthalmology, Cleveland Clinic, Cleveland, Ohio.
Ophthalmol Retina. 2018 Jun;2(6):558-566. doi: 10.1016/j.oret.2017.10.014. Epub 2017 Dec 19.
To evaluate benefit of continued treatment in diabetic macular edema (DME) eyes showing a limited early response to treatment.
Post hoc analysis of VISTA and VIVID.
818 patients (eyes) with DME.
Eyes with baseline central subfield thickness (CST) of ≥300 μm that received 2-mg intravitreal aflibercept injection (IAI) every 4 weeks (2q4) or every 8 weeks after 5 monthly injections (2q8) or laser control treatment were included in this analysis if they showed a limited early response at week 12 after 3 monthly injections or a single laser treatment at baseline, as defined by those who met: anatomic criteria (CST reduction ≤10% and CST >300 μm); visual criteria (best-corrected visual acuity [BCVA] gain <5 letters); or both. Least square (LS) means repeated measures were used to compare outcomes between initial (baseline-week 12) and later (weeks 16-100) periods within each treatment group.
Visual outcomes of eyes with limited early response through week 100.
In the anatomic subgroup, mean BCVA gains with 2q4 (n = 41) and 2q8 (n = 31) from baseline were 4.3 and 6.6 letters at week 12 and 8.6 and 8.5 letters at week 100, respectively. Corresponding LS mean differences for BCVA gains between initial and later periods were 3.0 (P = 0.0026) and 3.6 letters (P = 0.0017), respectively. In the visual subgroup, mean BCVA gains with 2q4 (n = 53) and 2q8 (n = 49) from baseline were 0.4 and 0.3 letters at week 12 and 6.1 and 4.1 letters at week 100, respectively. Corresponding LS mean differences for BCVA gains between initial and later periods were 5.0 (P < 0.0001) and 3.1 letters (P = 0.0008), respectively. In the combined subgroup, only a small percentage of IAI-treated eyes (<7%) met criteria. Regardless of type of limited early response, continued laser treatment did not result in additional BCVA gains through week 100.
Significant vision improvements were observed through week 100 with continued IAI treatment in a small number of DME eyes that showed a limited early response after 3 monthly IAI.
评估对治疗早期反应有限的糖尿病性黄斑水肿（DME）眼继续治疗的益处。
VISTA和VIVID的事后分析。
818例DME患者（眼）。
如果基线中心子野厚度（CST）≥300μm的眼在3次每月注射或基线单次激光治疗后第12周显示早期反应有限，则纳入本分析，这些眼接受每4周（2q4）或在5次每月注射后每8周（2q8）玻璃体内注射2mg阿柏西普（IAI）或激光对照治疗，符合以下条件者定义为早期反应有限：解剖学标准（CST降低≤10%且CST>300μm）；视觉标准（最佳矫正视力[BCVA]提高<5个字母）；或两者兼具。采用最小二乘（LS）均值重复测量来比较各治疗组内初始（基线至第12周）和后期（第16周至100周）的结果。
至第100周早期反应有限的眼的视觉结果。
在解剖学子组中，2q4组（n = 41）和2q8组（n = 31）从基线开始的平均BCVA提高在第12周分别为4.3和6.6个字母，在第100周分别为8.6和8.5个字母。初始期和后期BCVA提高的相应LS均值差异分别为3.0（P = 0.0026）和3.6个字母（P = 0.0017）。在视觉子组中，2q4组（n = 53）和2q8组（n = 49）从基线开始的平均BCVA提高在第12周分别为0.4和0.3个字母，在第100周分别为6.1和4.1个字母。初始期和后期BCVA提高的相应LS均值差异分别为5.0（P < 0.0001）和3.1个字母（P = 0.0008）。在联合子组中，仅一小部分接受IAI治疗的眼（<7%）符合标准。无论早期反应有限的类型如何，继续激光治疗至第100周均未导致BCVA进一步提高。
在少数3次每月IAI后早期反应有限的DME眼中，继续IAI治疗至第100周观察到视力有显著改善。
