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목적 : To investigate the short-term efficacy and safety of intravitreal aflibercept (IVT-AFL) for wet age-related macular degeneration patients in Korean real practice.
방법 : Korean Aflibercept Post Marketing Surveillance is an on-going study conducted in 78 institutions, nationwide. In this research, we analyzed the data from 1301 eyes of 1301 patients, who completed data collection from 2 MAY 2014 to 17 NOV 2017. For efficacy analysis, the mean changes of visual acuity (VA) and central retinal thickness (CRT) from baseline at 4 months and 8 months were analyzed in LOCF. To define the determinants for VA and CRT at 8 months, multiple regression analysis and logistic regression analysis were conducted. The incidence rates of AE and ADR were analyzed, as well.
결과 : At 4 and 8 months, 91.62% and 90.70% of patients improved and maintained vision (VA loss<0.3 logMAR units) respectively. Mean VA at 4 months and at 8 months increased from 0.66±0.44 at baseline to 0.56±0.46 and 0.54±0.46 logMAR (p<0.0001, p<0.0001) with mean number of injections of 2.81±0.49 and 3.60±0.94, respectively. A multiple regression analysis indicated that age, gender, injection number, PCV subtype (vs. non-PCV), baseline VA and CRT were significant determinants of visual acuity at 8 months. The safety profile was similar to previous multi-center clinical trials.
결론 : This was an observational study conducted with a large number of patients treated with aflibercept (IVT-AFL) for wet AMD. The efficacy and safety results generally showed consistency with previous pivotal studies. The study indicated injection number as an important modifiable factor for improved treatment outcomes.
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