玻璃体黄斑粘连对糖尿病性黄斑水肿中应用雷珠单抗治疗结局的影响（READ-3 研究）。
Effect of Vitreomacular Adhesion on Treatment Outcomes in the Ranibizumab for Edema of the Macula in Diabetes (READ-3) Study.
机构信息
Ocular Imaging Research and Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska.
Ocular Imaging Research and Reading Center, Stanley M. Truhlsen Eye Institute, University of Nebraska Medical Center, Omaha, Nebraska; Department of Ophthalmology, Assiut University, Assiut, Egypt.
出版信息
Ophthalmology. 2016 Feb;123(2):324-329. doi: 10.1016/j.ophtha.2015.09.032. Epub 2015 Oct 29.
PURPOSE
To assess the role of vitreomacular adhesion (VMA) in visual and anatomic outcomes in patients with diabetic macular edema (DME).
DESIGN
Retrospective cohort study.
PARTICIPANTS
Data from patients enrolled in the Ranibizumab for Edema of the Macula in Diabetes: Protocol 3 with High Dose (READ-3) study were analyzed.
METHODS
In the READ-3 study, patients with DME received monthly intravitreal injections of either 0.5 or 2.0 mg ranibizumab. Optical coherence tomography images from patients who completed the month 6 visit of the study were analyzed at the baseline visit to identify the presence (VMA+) or absence (VMA-) of VMA. Patients with any degree of vitreomacular traction were excluded from the analysis. Two independent graders graded all images. Vitreomacular adhesion was classified by size of adhesion into either focal (<1500 μm) or broad (≥1500 μm).
MAIN OUTCOME MEASURES
Mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) at month 6 and incidence of posterior vitreous detachment (PVD).
RESULTS
One hundred fifty-two eyes (152 patients) were randomized in the READ-3 study. One hundred twenty-four eyes (124 patients) were eligible for the study based on study criteria. Twenty-eight eyes did not meet study criteria and were excluded from the study. At baseline, 26 patients were classified as VMA+ and 98 patients were classified as VMA-. The distribution of the 2 doses of ranibizumab (0.5 and 2.0 mg) in the 2 groups was similar. At month 6, the mean improvement in BCVA was 11.31±6.67 and 6.86±7.58 letters in the VMA+ and VMA- groups, respectively (P = 0.007). Mean improvement in CRT was -173.81±132.31 and -161.84±131.34 μm in the VMA+ and VMA- groups, respectively (P = 0.681). At month 6, among the 26 VMA+ eyes (at baseline), 7 eyes demonstrated PVD, 17 eyes showed no change in VMA status, and 2 eyes were not gradable and were excluded.
CONCLUSIONS
Diabetic macular edema patients with VMA have a greater potential for improvement in visual outcomes with anti-vascular endothelial growth factor therapy. Therefore, the presence of VMA should not preclude patients with DME from receiving treatment.
目的
评估糖尿病黄斑水肿（DME）患者中玻璃体黄斑粘连（VMA）在视力和解剖结果中的作用。
设计
回顾性队列研究。
参与者
分析了参加雷珠单抗治疗糖尿病黄斑水肿：高剂量方案 3（READ-3）研究的患者的数据。
方法
在 READ-3 研究中，DME 患者每月接受玻璃体腔内注射 0.5 或 2.0mg 雷珠单抗。在研究的第 6 个月就诊时，对完成研究的患者的光学相干断层扫描图像进行分析，以确定是否存在（VMA+）或不存在（VMA-）VMA。排除了任何程度的玻璃体黄斑牵引的患者。两名独立的分级员对所有图像进行分级。根据粘连大小，将玻璃体黄斑粘连分为局灶性（＜1500μm）或广泛（≥1500μm）。
主要观察指标
第 6 个月最佳矫正视力（BCVA）和中心视网膜厚度（CRT）的平均变化以及后玻璃体脱离（PVD）的发生率。
结果
READ-3 研究共纳入 152 只眼（152 例患者）。根据研究标准，124 只眼（124 例患者）符合研究条件。28 只眼不符合研究标准，被排除在研究之外。在基线时，26 例患者被分类为 VMA+，98 例患者被分类为 VMA-。两组雷珠单抗（0.5 和 2.0mg）的剂量分布相似。第 6 个月时，VMA+和 VMA-组的 BCVA 平均改善分别为 11.31±6.67 和 6.86±7.58 个字母（P=0.007）。VMA+和 VMA-组 CRT 的平均改善分别为-173.81±132.31 和-161.84±131.34μm（P=0.681）。第 6 个月时，在 26 只 VMA+眼（基线时）中，7 只眼出现 PVD，17 只眼 VMA 状态无变化，2 只眼无法分级，被排除在外。
结论
患有 VMA 的糖尿病黄斑水肿患者在接受抗血管内皮生长因子治疗后视力改善的潜力更大。因此，VMA 的存在不应阻止 DME 患者接受治疗。
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