Clinical trial of ranibizumab combined with dexamethasone intravitreal implant in the treatment of macular edema secondary to retinal vein obstruction
10.13699/j.cnki.1001-6821.2023.23.012
- VernacularTitle:雷珠单抗联合地塞米松玻璃体内植入剂治疗视网膜静脉阻塞继发黄斑水肿的临床研究
- Author:
Yi-Meng RUAN
1
;
Dong-Wei YAO
;
Yan SHI
Author Information
1. 宁波大学附属第一医院/宁波市第一医院眼科,浙江宁波 315000
- Keywords:
ranibizumab injection;
dexamethasone intravitreal implant;
retinal vein occlusion;
macular edema;
clinical efficacy;
safety evaluation
- From:
The Chinese Journal of Clinical Pharmacology
2023;39(23):3397-3400
- CountryChina
- Language:Chinese
-
Abstract:
Objective To observe the clinical efficacy and safety of ranibizumab injection combined with dexamethasone intravitreal implant in the treatment of macular edema secondary to retinal vein obstruction(RVO-ME).Methods The RVO-ME patients were divided into control and treatment groups.Control group received intravitreal ranibizumab injection 0.05 mL once a month for 3 consecutive times.Treatment group received the intravitreal ranibizumab injection 0.05 mL combined with intravitreal injection of dexamethasone intravitreal implant 0.7 mg.Two groups were given another intravitreal injection of ranibizumab as needed,if the macular edema did not fully subside or relapsed.Two groups were followed up for six months.The best-corrected visual acuity(BCVA),central macular thickness(CMT),macular vascular density(MVD)of superficial retinal vascular complex(SVC)and macular deep vascular complex(DVC),the area of foveal avascular area(FAZ),number of injections on-demand treatment and adverse drug reactions were compared between two groups.Results Twenty cases in the control group were included,and 16 cases in the treatment group were included.After 6 months of treatment,the BCVA of treatment and control groups were 0.58±0.16 and 0.47±0.19;CMT were(313.00±53.55)μm and(293±40.47)μm;SVC-MVD were(56.82±8.89)％and(53.18±8.17)％;SVC-FAZ were(0.58±0.16)and(0.47±0.19)mm2;DVC-FAZ were(0.29±0.07)and(0.31±0.08)mm2;and the differences were not statistically significant(all P＞0.05).After 6 months of treatment,the DVC-MVD of treatment and control groups were(52.68±6.72)％and(43.87±3.18)％;the number of injections on-demand treatment was 0.25±0.45 and 1.05±0.76,the differences were statistically significant(all P＜0.05).The adverse drug reactions in the treatment group were subconjunctival hemorrhage and increased intraocular pressure,and those in control group were subconjunctival hemorrhage.The total incidences of adverse drug reactions in treatment and control groups were 12.50％and 15.00％,without significant difference(P＞0.05).Conclusion The clinical efficacy of ranibizumab injection combined with dexamethasone intravitreal implant and ranibizumab injection alone in the treatment of the patients with RVO-ME was similar.However,the recovery of blood flow density in the retinal DVC layer after the former treatment is faster,which can obtain more lasting clinical efficacy,without increasing the incidence of adverse drug reactions.
