Treatment patterns, visual acuity and quality-of-life outcomes of the WAVE study - A noninterventional study of ranibizumab treatment for neovascular age-related macular degeneration in Germany

被引:136
作者
Finger, Robert P. [1 ]
Wiedemann, Peter [2 ]
Blumhagen, Francisca [3 ]
Pohl, Karin [3 ]
Holz, Frank G. [1 ]
机构
[1] Univ Bonn, Dept Ophthalmol, D-53127 Bonn, Germany
[2] Univ Leipzig, Dept Ophthalmol, D-04109 Leipzig, Germany
[3] Novartis Pharma GmbH, Novartis Ophthalm, Nurnberg, Germany
关键词
age-related macular degeneration; clinical trial; neovascularization; treatment medical;
D O I
10.1111/j.1755-3768.2012.02493.x
中图分类号
R77 [眼科学];
学科分类号
100212 [眼科学];
摘要
Purpose: To evaluate effectiveness, tolerability and safety of repeated intravitreal injections of 0.5mg ranibizumab for the treatment of neovascular age-related macular degeneration in routine medical practice in Germany. Methods: A noninterventional study with 3470 patients treated in 274 medical centres according to German guidelines, with monthly intravitreal injections of 0.5mg ranibizumab during upload (3months) followed by a maintenance phase (9months) with reinjections if medically indicated. Results: Mean injection rate was 4.34 (SE=0.05; median=3.0). Best-corrected visual acuity (BCVA) remained stable (mean change 0.02 LogMAR, SE=0.01, p=0.0169) and central retinal thickness (CRT) decreased (by -78.9m, SE=2.95m, p<0.0001). The NEI-VFQ 25 summary score showed a positive stabilization with a mean change of 0.73 (SE=0.37, p=0.0501) compared with baseline. Adverse events were documented for 6.5% of the patients with 3.9% of these events being classified as serious. Conclusions: The number of administered intravitreal injections of ranibizumab over the first year of treatment was very low but still achieved a stabilization of BCVA, a reduction in CRT and maintained vision-related quality of life. The management of patients with neovascular AMD in Germany needs to be improved to achieve better treatment results.
引用
收藏
页码:540 / 546
页数:7
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