One-year results of modified Treat-and-Extend regimen using aflibercept for diabetic macular edema; VIBIM study

Abstract

Purpose : To investigate the efficacy of modified treat-and-extend (TnE) regimen using aflibercept for diabetic macular edema.

Methods : This was a prospective multi-center single-arm study planned for two years. Eight centers enrolled 48 eyes with diabetic macular edema complicated in type 1 or 2 diabetes mellitus. The eyes received five consecutive intravitreal injections of 2mg aflibercept every 4 weeks and then the injection interval was adjusted by 2 weeks based on changes of central subfield macular thickness (CSMT). If CSMT was worse, stable or better, the interval was shortened, extended and maintained, respectively. The primary outcome was the change in best-corrected visual acuity (BCVA) from baseline at 104 weeks, and the secondary outcomes include the change in BCVA at 52 weeks.

Results : Of enrolled 48 patients, 46 completed one-year visit. BCVA increased significantly by 8.9 letters from 52.5 letters at baseline (P<0.0001), and CSMT decreased by -171.7 from 489.4 to 317.7 μm (P<0.0001). Proportion of eyes having 20/40 or better vision increased from 17.4% to 41.3%, and proportion of eyes gained 15 letters or more was 28.3%. The mean number of injections was 8.5 times for 52 weeks. Worsening of macular edema was experienced in 23.9% during the extension period, and the injection interval was extended to 12 weeks in 73.9%.

Conclusions : The modified TnE regimen of the current study showed similar efficacy to the fixed dosing regimen of the pivotal trials, and its flexible dosing would avoid overtreatment. The second year of the study is ongoing.

This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.