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

Abstract

Purpose: To evaluate effectiveness, tolerability and safety of repeated intravitreal injections of 0.5 mg 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 0.5 mg ranibizumab during upload (3 months) followed by a maintenance phase (9 months) 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 -78.9 μm, SE = 2.95 μm, 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.

Keywords: age-related macular degeneration; clinical trial; neovascularization; treatment medical.