Fouda Sameh Mosaad, Bahgat Ahmed M
Department of Ophthalmology, Faculty of Medicine, Zagazig University, Zagazig, Egypt.
Clin Ophthalmol. 2017 Mar 23;11:567-571. doi: 10.2147/OPTH.S131381. eCollection 2017.
The purpose of this study was to compare the efficacy of intravitreal aflibercept and ranibizumab in the treatment of diabetic macular edema (DME) in eyes with moderate visual loss.
This study is a randomized prospective study. Seventy eyes with DME were divided into two groups (each containing 35 eyes). Eyes in group I were treated with intravitreal injection of 2 mg/0.05 mL aflibercept and eyes in group II were treated with intravitreal injection of 0.5 mg/0.1 mL ranibizumab. All the eyes had three successive injections as a loading dose (with 1 month interval), and then the patients were followed up monthly for 12 months. The outcomes of the study were visual acuity, central macular thickness (CMT), and the number of re-injections of the drug.
Mean age of the patients in group I was 55.05±4.7 years and in group II was 56.64±5.8 years (=0.17). The mean baseline best corrected visual acuity (BCVA) of eyes treated with aflibercept was 0.17±0.05 and with ranibizumab was 0.18±0.04 (=0.9). BCVA was improved in both the groups at the end of the follow-up period and was found to be 0.42±0.28 and 0.37±0.23, respectively (=0.27). The mean baseline CMT of eyes in group I was 465.29±33.7 µm and in group II was 471.5±34.4 µm (=0.65). CMT decreased in both the groups to 360.8±85.7 µm and 387.3±87.8 µm, respectively (=0.2). The mean number of drug re-injection was 2.62±0.68 and 3.03±0.95 in both the groups, respectively (=0.02).
Aflibercept and ranibizumab have the same efficacy in the treatment of DME in eyes with moderate visual loss but with less number of drug re-injection and less treatment burden with aflibercept (2.62±0.68 versus 3.03±0.95).
本研究旨在比较玻璃体内注射阿柏西普和雷珠单抗治疗中度视力丧失的糖尿病性黄斑水肿(DME)的疗效。
本研究为随机前瞻性研究。70只患有DME的眼睛被分为两组(每组35只眼睛)。第一组眼睛接受玻璃体内注射2mg/0.05mL阿柏西普治疗,第二组眼睛接受玻璃体内注射0.5mg/0.1mL雷珠单抗治疗。所有眼睛均连续注射三次作为负荷剂量(间隔1个月),然后对患者进行每月一次的随访,为期12个月。研究结果包括视力、中心黄斑厚度(CMT)和药物再次注射次数。
第一组患者的平均年龄为55.05±4.7岁,第二组为56.64±5.8岁(P=0.17)。接受阿柏西普治疗的眼睛的平均基线最佳矫正视力(BCVA)为0.17±0.05,接受雷珠单抗治疗的眼睛为0.18±0.04(P=0.9)。随访期结束时,两组的BCVA均有所改善,分别为0.42±0.28和0.37±0.23(P=0.27)。第一组眼睛的平均基线CMT为465.29±33.7µm,第二组为471.5±34.4µm(P=0.65)。两组的CMT均下降,分别降至360.8±85.7µm和387.3±87.8µm(P=0.2)。两组的药物再次注射平均次数分别为2.62±0.68和3.03±0.95(P=0.02)。
阿柏西普和雷珠单抗在治疗中度视力丧失的眼睛的DME方面具有相同的疗效,但阿柏西普的药物再次注射次数较少,治疗负担较轻(2.62±0.68对3.03±0.95)。