Journal
ACTA OPHTHALMOLOGICA
Volume 91, Issue 6, Pages 540-546Publisher
WILEY-BLACKWELL
DOI: 10.1111/j.1755-3768.2012.02493.x
Keywords
age-related macular degeneration; clinical trial; neovascularization; treatment medical
Categories
Funding
- Novartis Pharma Germany
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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.
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