Effect of simultaneous intravitreal ranibizumab and extended-release dexamethasone injection on patients with naïve versus refractory retinal vein occlusion macular edema:a prospective,multicenter,and interventional open-label study  

作　　者：Yao-Yao Sun Jie Meng Shan-Shan Li Qin Xiao Tian-Zi Zhang Heng Miao Ming-Wei Zhao Hui-Jun Qi 

机构地区：[1]Department of Ophthalmology,Peking University People’s Hospital,Beijing 100034,China [2]Beijing Key Laboratory of Ocular Disease and Optometry Science,Beijing100034,China [3]Eye Institute of Shandong,State Key Laboratory Cultivation Base,Shandong Provincial Key Laboratory Cultivation Base,Shandong Provincial Key Laboratory of Ophthalmology,Qingdao 266000,Shandong Province,China [4]Department of Ophthalmology,Qilu Hospital of Shandong University,Jinan 250012,Shandong Province,China [5]Department of Ophthalmology,Affiliated Hospital of Inner Mongolia University for the Nationalities,Tongliao 028000,Inner Mongolia Autonomous Region,China

出　　处：《International Journal of Ophthalmology(English edition)》2025年第5期860-867,共8页国际眼科杂志(英文版)

基　　金：Supported by the National Nature Science Foundation of China(No.82301211);Beijing Natural Science Foundation(No.J230028).

摘　　要：AIM:To evaluate the efficacy and safety of concurrent intravitreal ranibizumab(IVR)and extended-release dexamethasone injections(Dex-I)in naïve and refractory patients with retinal vein occlusion macular edema(RVO-ME).METHODS:This was a prospective,interventional,and open-label clinical trial.There were two groups:naïve and refractory patients(received≥5 times of previous IVR within one year prior to enrollment)enrolled.Patients received IVR and Dex-I concurrently and re-combination therapy was required if one or more retreatment criteria were met.IVR and Dex-I were given pro re nata(PRN).The mean changes in best-corrected visual acuity(BCVA)and central macular thickness(CMT)were measured as main outcomes.RESULTS:Totally 63 patients(63 eyes)completed the entire follow-up(31 naïve and 32 refractory patients).At month 12,the change in BCVA was greater in the naïve group than in the refractory group[19.67±11.7(95%CI:15.03,24.31)letters vs 11.74±11.18(95%CI:7.32,16.16)letters,P=0.014].There was no difference between the two groups of mean macular thickness reduction[364.26±215.29(95%CI:279.09,449.43)μm vs 410.19±204.34(95%CI:329.35,491.02)μm,P=0.43].The mean co-injection numbers were 2.52±0.58(95%CI:2.29,2.75)and 2.33±0.55(95%CI:2.11,2.55)in both groups(P=0.24),respectively.The retreatment interval was 115.81±13.79 d(95%CI:110.36,121.27)and 122.74±14.06 d(95%CI:119.93,133.56)in both groups(P=0.073).There was no significant difference in the incidence of glaucoma or the progression of cataracts between the two groups.CONCLUSION:In both naïve and refractory RVO-ME patients,IVR combined with Dex-I is effective.The initial combination therapy for naïve patients demonstrates more efficient improvement in BCVA and may reduce total injection numbers compared to refractory patients.

关 键 词：retinal vein occlusion macular edema prospective clinical trial anti-vascular endothelial growth factor dexamethasone implant 

分 类 号：R774.1[医药卫生—眼科]