Ozsaygılı Cemal, Bayram Nurettin
Department of Ophthalmology, University of Health Sciences, Kayseri City Training and Research Hospital, Kocasinan, Kayseri, Turkey.
University of Health Sciences, Ankara Etlik City Hospital, Yenimahalle, Ankara, Turkey.
Int Ophthalmol. 2024 Feb 9;44(1):51. doi: 10.1007/s10792-024-02963-8.
To compare the anatomical and functional outcomes of the combination of aflibercept and dexamethasone implant (CT) against aflibercept monotherapy (AM) in treatment-naive diabetic macular edema (DME) patients with serous macular detachment and hyperreflective foci.
This study included 82 eyes of 82 patients with treatment-naive DME who completed the follow-up period of 12 months. All patients had optical coherence tomography biomarkers of an inflammatory DME phenotype. Patients were consecutively selected and classified into two groups: The CT group consisted of 39 eyes treated with aflibercept therapy and initially combined with a single-dose dexamethasone implant. The AM group consisted of 43 eyes treated with aflibercept alone. The primary outcome measures of the study were the mean reduction of the central macular thickness (CMT) and total macular volume parameters (TMV) and improvement in best-corrected visual acuity.
In both groups, the patient characteristics, including age, gender, duration of diabetes, HbA1c levels, phakic percentage, and diabetic retinopathy status were similar (P > 0.05). The mean reduction in CMT and TMV was significantly higher in the CT group compared to the AM group (P < 0.001 and P = 0.002, respectively). In contrast, mean letter gains were not significantly higher (P = 0.240) at the end of the study. In the CT group, 20.5% of patients showed a transient IOP increase, and 18% developed cataracts. In subgroup analysis, the mean letter gain in pseudophakic eyes was significantly higher (12.5 in the CT vs. 9.3 in the AM group, P = 0.027).
The CT, where inflammation is prominent, can provide faster recovery. The pseudophakic eyes seem to be the ideal patient group for CT.
比较阿柏西普与地塞米松植入剂联合治疗（CT）和阿柏西普单药治疗（AM）对初治的伴有浆液性黄斑脱离和高反射灶的糖尿病性黄斑水肿（DME）患者的解剖学和功能结局。
本研究纳入了82例初治DME患者的82只眼，这些患者均完成了12个月的随访期。所有患者均有炎症性DME表型的光学相干断层扫描生物标志物。患者被连续入选并分为两组：CT组由39只接受阿柏西普治疗并初始联合单剂量地塞米松植入剂的眼组成。AM组由43只仅接受阿柏西普治疗的眼组成。该研究的主要结局指标为中心黄斑厚度（CMT）和黄斑总体积参数（TMV）的平均降低以及最佳矫正视力的改善。
两组患者的特征，包括年龄、性别、糖尿病病程、糖化血红蛋白水平、晶状体眼百分比和糖尿病视网膜病变状态均相似（P>0.05）。与AM组相比，CT组CMT和TMV的平均降低幅度显著更高（分别为P<0.001和P=0.002）。相比之下，研究结束时平均字母提高并不显著更高（P=0.240）。在CT组中，20.5%的患者出现短暂眼压升高，18%的患者发生白内障。在亚组分析中，人工晶状体眼的平均字母提高显著更高（CT组为12.5，AM组为9.3，P=0.027）。
在炎症突出的情况下，CT能提供更快的恢复。人工晶状体眼似乎是CT的理想患者群体。
