부산대학교 도서관

Purpose: The prevalence of diabetes and diabetes-related complications, including diabetic macular edema (DME), is increasing in Asia and worldwide. Methods: VIVID-East was a 12-month, double-masked, randomized, active-controlled, Phase 3 trial (NCT01783886) enrolling adult patients (aged [greater than or equal to]18 years) with DME at 25 centers across China, Hong Kong, Republic of Korea, and Russia. Eyes were randomized 1:1:1 to 2 mg intravitreal aflibercept (IVT-AFL) every 4 weeks (2q4; N=127), 2 mg IVT-AFL every 8 weeks (after 5 initial monthly doses from baseline to week 16) with sham injections on nontreatment visits (2q8; N=127), or macular laser photocoagulation at baseline and sham injections at every visit (laser control group; N=124). The primary efficacy endpoint was mean change in best corrected visual acuity (BCVA) from baseline to week 52. Results: Compared with baseline, at week 52 the mean (SE) BCVA in the 2q4 and 2q8 groups gained+13.6 (0.9) and+13.1 (1.0) letters, respectively, versus -0.5 (1.4) letters in the laser group (P Conclusion: IVT-AFL treatment resulted in significant visual and anatomic improvements in Asian patients with DME. Treatment benefits observed in the overall study population were mirrored in the subgroup of Chinese patients, who made up the largest population group in the study. Study Registration: NCT01783886. Keywords: Asia, Chinese, intravitreal aflibercept, diabetic macular edema
Introduction One-third of patients with diabetes have ocular complications. (1) Retinal vascular leakage can lead to an accumulation of excess extracellular fluid, manifesting as diabetic macular edema (DME). (2) Half [...]