Wickremasinghe Sanjeewa S, Fraser-Bell Samantha, Alessandrello Elizabeth, Mehta Hemal, Gillies Mark C, Lim Lyndell L
Centre for Eye Research Australia, University of Melbourne, Melbourne, Victoria, Australia.
Royal Victorian Eye and Ear Hospital, Melbourne, Victoria, Australia.
Br J Ophthalmol. 2017 Oct;101(10):1329-1333. doi: 10.1136/bjophthalmol-2016-309882. Epub 2017 Feb 22.
To compare changes in retinal vascular calibre after 2 years of treatment with intravitreal bevacizumab (BVZ) or dexamethasone implant (DEX) in patients with centre-involving diabetic macular oedema (DMO).
At baseline, 88 eyes of 61 patients with DMO were recruited in a prospective, multicentre, randomised, single-masked clinical trial. Of these subjects, 22 BVZ-treated (52%) and 22 DEX-treated (48%) eyes of 34 patients (56%) had gradable retinal photographs at both the baseline and 24-month visits. Retinal vascular calibre was measured from digital fundus photographs and summarised as central retinal artery (CRAE) and vein (CRVE) equivalents in all gradable eyes at baseline and 24 months.
At 24 months, 40.9% of BVZ and 45.5% of DEX eyes gained 10 or more letters (p=0.77). There was concurrent reduction in mean central macular thickness, -157.7 μm in BVZ and -192.5 μm in DEX-treated eyes (p=0.40). DEX-treated eyes showed a statistically significant reduction in CRVE compared with BVZ-treated eyes, with a mean change from baseline of -31.78 to +4.34 µm, respectively (p<0.001). CRAE showed a non-statistically significant trend towards reduction over time in DEX-treated eyes compared with BVZ-treated eyes, with a mean change from baseline of -6.09 and +1.66, respectively (p=0.077).
DEX had a significant narrowing effect on venular diameter in eyes with DMO not seen with BVZ. The changes in retinal vascular calibre suggest that these agents have a differing actions effects retinal vasculature and thereby suggest a potentially different mechanism of action on reducing DMO.
NCT01298076.
比较玻璃体内注射贝伐单抗(BVZ)或地塞米松植入物(DEX)治疗累及黄斑中心的糖尿病性黄斑水肿(DMO)2年后视网膜血管管径的变化。
在一项前瞻性、多中心、随机、单盲临床试验中,纳入了61例DMO患者的88只眼作为基线研究对象。其中,34例患者(56%)的22只接受BVZ治疗的眼(52%)和22只接受DEX治疗的眼(48%)在基线和24个月随访时均有可分级的视网膜照片。从数字眼底照片测量视网膜血管管径,并将其总结为所有可分级眼在基线和24个月时的视网膜中央动脉(CRAE)和静脉(CRVE)等效值。
在24个月时,40.9%接受BVZ治疗的眼和45.5%接受DEX治疗的眼视力提高了10个或更多字母(p = 0.77)。黄斑中心平均厚度同时降低,接受BVZ治疗的眼降低了-157.7μm,接受DEX治疗的眼降低了-192.5μm(p = 0.40)。与接受BVZ治疗的眼相比,接受DEX治疗的眼CRVE有统计学显著降低,从基线的平均变化分别为-31.78至+4.34μm(p < 0.001)。与接受BVZ治疗的眼相比,接受DEX治疗的眼CRAE随时间有非统计学显著的降低趋势,从基线的平均变化分别为-6.09和+1.66(p = 0.077)。
DEX对DMO患眼的小静脉直径有显著的缩窄作用,而BVZ则没有。视网膜血管管径的变化表明,这些药物对视网膜血管系统有不同的作用,从而提示它们在减轻DMO方面可能有不同的作用机制。
NCT01298076。