玻璃体注射法瑞西单抗治疗新生血管性年龄相关性黄斑变性的效果OA

Objective To analyze the clinical efficacy and safety of intravitreal injection of faricimab injection in the treatment of neovascular age-related macular degeneration(nAMD).Methods Patients with nAMD were randomly divided into control group and treatment group.Both groups were treated according to the 3+PRN protocol(1 injection every 4 weeks for the first 3 months,and one follow-up every 4 weeks from the 4th month until 24 weeks).At 3 days before surgery,0.5％moxifloxacin hydrochloride eye drops were administered(4 times a day)to both groups.The control group was treated with intravitreal injection of aflibercept injection(2.0 mg each time),while the treatment group was treated with intravitreal injection of faricimab injection(0.05 mL each time).The best corrected visual acuity(BCVA),central macular thickness(CMT)and choriocapillaris vessel density(CCVD)before treatment and at 4 weeks,8 weeks,12 weeks and 24 weeks of treatment as well as supplementary treatment situations were compared between control group and treatment group,and the safety evaluation was performed.Results A total of 80 patients were enrolled in this study,comprising 40 cases in control group and 40 cases in treatment group.At 12 weeks of treatment,the total effective rate in control group was 72.50％(29 cases/40 cases)and that in treatment group was 75.00％(30 cases/40 cases),without statistically significant difference(P＞0.05).At 4 weeks of treatment,BCVA of control group and treatment group were 0.71±0.10 and 0.68±0.11,respectively;CMT were(322.25±30.25)and(317.35±33.18)pum,respectively;CCVD were(63.87±2.11)％and(63.45±2.65)％,respectively.At 8 weeks of treatment,BCVA of control group and treatment group were 0.59±0.12 and 0.55±0.13,respectively;CMT were(296.22±28.35)and(288.18±26.59)μm,respectively;CCVD were(63.11±2.75)％and(62.88±2.61)％,respectively.At 12 weeks of treatment,BCVA of control group and treatment group were 0.39±0.08 and 0.37±0.07,respectively;CMT were(282.14±27.22)and(273.46±25.19)μm,respectively;CCVD were(62.07±2.74)％and(61.77±2.83)％,respectively.At 24 weeks of treatment,BCVA of control group and treatment group were 0.43±0.11 and 0.40±0.09,respectively;CMT were(303.58±50.64)and(281.49±27.12)pum,respectively;CCVD were(63.61±3.10)％and(62.24±2.86)％,respectively.At 24 weeks of treatment,the differences of CMT and the CCVD values in control group and treatment group were all statistically significant(all P＜0.05).Except these,the differences of above indicators in control group and treatment group in different time were not all statistically significant(all P＞0.05).The number of patients requiring supplementary treatment within 24 weeks was 10 cases(25.00％)in control group and 2 cases(5.00％)in treatment group(P＜0.05).Adverse drug reactions included cataract,conjunctival hemorrhage,vitreous detachment,elevated intraocular pressure,vitreous floaters and eye pain.The overall incidence rate of adverse drug reactions of control group and treatment group were 20.00％(8 cases/40 cases)and 12.50％(5 cases/40 cases):without statistically significant difference(P＞0.05).Conclusion The overall efficacy and safety of intravitreal injection of faricimab in the treatment of nAMD are similar to those of aflibercept injection,but it has more advantages in the persistence of efficacy.