期刊
GRAEFES ARCHIVE FOR CLINICAL AND EXPERIMENTAL OPHTHALMOLOGY
卷 259, 期 8, 页码 2213-2223出版社
SPRINGER
DOI: 10.1007/s00417-021-05073-8
关键词
Age-related macular degeneration; nAMD; wAMD; Neovascular; VEGF; Intravitreal; Aflibercept; Real-world evidence
资金
- Bayer Vital GmbH [EY1313]
- Bayer Vital GmbH, Leverkusen, Germany
In this study in Germany, regular intravitreal aflibercept injections resulted in better visual outcomes at 24 months for patients with neovascular age-related macular degeneration compared to irregular treatment. However, only a minority of patients received regular treatment over a 2-year period.
Purpose To evaluate the real-world effectiveness of intravitreal aflibercept injections in Germany in patients with neovascular age-related macular degeneration over 24 months. Methods PERSEUS was a prospective, non-interventional cohort study. The primary endpoint was the mean change in visual acuity (VA) from baseline. Secondary endpoints included the proportion of patients with a VA gain or loss of >= 15 letters and the frequency of injections and examinations. Patients with regular (bimonthly after 3 monthly injections during year 1 and >= 4 injections in year 2) and irregular (any other) treatment were analyzed. The last observation carried forward (LOCF) and the observed cases (OC) approach was applied for primary endpoint analysis to account for missing data. Results 803 patients were considered for effectivity analysis. At month 24, only 38% of the patients were still under observation. The LOCF population included 727, the OC population 279 patients. Treatment-naive patients improved by 6.3 (LOCF)/8.1 (OC) letters with regular treatment over 24 months but only by 3.3 (LOCF)/3.1 (OC) letters with irregular treatment. The proportion of treatment-naive patients achieving a VA improvement of >= 15 letters was similar between regularly and irregularly treated cohorts. However, considerably more patients in the irregular cohorts experienced a VA worsening of >= 15 letters than in the regular cohorts (LOCF: 18.7% vs. 7.4%). Conclusions Regular IVT-AFL treatment resulted in better VA outcomes than irregular treatment at month 24. However, only a minority of patients received regular treatment over a 2-year period.
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