Clinical characteristics and outcomes after 5 years pro re nata treatment of neovascular age‐related macular degeneration with ranibizumab

We present the outcomes of a cohort of 68 patients from a single centre who have completed 5 years of treatment with ranibizumab for neovascular age-related macular degeneration (nvAMD) from 2007 to 2013. Previous studies have shown the stability of vision in the postinitiation phase to be the most important marker of outcomes for patients (Ross et al. 2013; Tschuor et al. 2013). To the best of our knowledge, there are no published 5-year longitudinal data in the ‘real world’ setting. Data pertaining to VA, central retinal thickness (CRT), number of visits and injections were collected retrospectively at six monthly intervals following three monthly initiation doses of intravitreal ranibizumab 0.5 mg followed by a pro re nata re – treatment regimen. Patient demographics were typical of published series with a mean age of 83.4 years (SD 5.6), a 1:1.95 female preponderance and occult choroidal neovascular membrane (48%) followed by minimally classic (31%) being the most common angiographic lesions. The mean visual acuity was 47.0 (SD 15.0) ETDRS letters at baseline, improving to 54.1 (SD 13.9, p = 0.004, anova) at 6 months, with a mean of 52.7 (SD 16.9) at 60 months. Following on from 6 months, there was no significant change to other time-points (p > 0.05) (Fig. 1). The mean CRT was 328.4 (SD 80.2) microns at baseline, decreasing to 272.1 (SD 47.3, p = 0.000) at 6 months with a further significant decrease to 230.2 (SD 48.5, p = 0.003) microns at 60 months (Fig. 1). The median numbers of injections in years 1–5 were 6, 4, 4, 4 and 7 respectively. In the first year, the median number of visits was 9 this value decreases to 7 and 6 in years 2 and 3 increased to and 8 and 10 in years 4 and 5 following service redesign. These data show that vision can be stabilized over 5 years and compares favourably with other long duration data sets: the Neovascular Age-related Macular Degeneration database (NV AMD database) and the SEVEN-UP study. The NV AMD database shows the largest real world visual acuity results from a cohort of nearly 13 000 eyes also treated with ranibizumab over a 3-year period. It showed that the initial gain of approximately three ETDRS letters was followed by a mean decline in visual acuity of 1–2 ETDRS letters from baseline at the end of 3 years. This was achieved with a median number of injections of 5, 4 and 4 in years 1, 2 and 3, respectively (Tufail et al. 2014). The SEVEN-UP study, a cross-sectional analysis of clinical trial data followed by real world data over 7 years, shows a peak VA gain of 11.2 letters. This was achieved at the end of intensive monthly ranibizumab therapy as part of the MARINA and ANCHOR studies. However, after exiting these studies and the following HORIZON extension study, the mean visual acuity reduced significantly by 8.6 letters (p < 0.005) from baseline with mean number of 3.1 injections (Rofagha et al. 2013). Being able to predict the outcome for an individual is important when counselling patients and planning services (Amoaku et al. 2012). This retrospective real world study contributes to benchmarking of outcomes in the real world setting. Its main limitation as with the NV AMD database and SEVEN-UP studies is that the drop-out rate of patients has not been quantified.