Multi-country real-life experience of anti-vascular endothelial growth factor therapy for wet age-related macular degeneration

Abstract

Background/aimsReal-life anti-vascular endothelial growth factor (VEGF) therapy use in patients with wet age-related macular degeneration (wAMD) was assessed in a retrospective, observational study in Canada, France, Germany, Ireland, Italy, the Netherlands, UK and Venezuela.MethodsMedical records of patients with wAMD, who started ranibizumab treatment between 1 January 2009 and 31 August 2009, were evaluated. Data were collected until the end of treatment and/or monitoring or until 31 August 2011.Results2227 patients who received ≥1 anti-VEGF injection with a baseline visual acuity assessment and ≥1 postbaseline visual acuity assessment for the treated eye were evaluated. Visual acuity improved until about day 120; thereafter, visual acuity gains were not maintained. Mean change in visual acuity score from baseline to years 1 and 2 was +2.4 and +0.6 letters, respectively. Patients received a mean of 5.0 and 2.2 injections in the first and second year, respectively. There were substantial differences in visual outcomes and injection frequency between countries. More frequent visits and injections were associated with greater improvements in visual acuity.ConclusionsIn clinical practice, fewer injections are administered than in clinical trials. Anti-VEGF treatment resulted in an initial improvement in visual acuity; however, this was not maintained over time.Trial registration numberNCT01447043.

Risk for Low Visual Acuity After 1 and 2 Years of Treatment With Ranibizumab or Bevacizumab for Patients With Neovascular Age-Related Macular Degeneration

“…Our results regarding the improvement in VA are lower compared with those reported in clinical trials (see Figure 2). Other observational studies also found lower VA improvement [10][11][12] . These differences could be due to different treatment programs and differences between the study populations.…”

“…AURA was an observational multi-country study including 2 227 patients treated with ranibizumab in standard clinical practice 11 . The authors found that the number of injections given in clinical practice is less than in clinical trials (mean injections at 1 year = 5 and at 2 years = 2.2) and that the mean change in VA was + 2.4 and + 0.6 letters at 1 and 2 years respectively.…”

Ranibizumab for the treatment of wet AMD: a summary of real-world studies

“…[17][18][19][20][21] These poor visual outcomes may stem from an inability to adhere to strict a PRN regimen (which is required for PRN to be effective) in routine clinical practice; this hypothesis is supported by the low injection frequency reported by these studies (a mean number of 4.3-5.1 injections over 12 months). 17,[19][20][21] To better understand the overall picture concerning the real-world effectiveness of ranibizumab, a review of the literature was conducted to identify studies of ranibizumab in clinical practice. This review provides both a summary of the design and methodological quality of the studies and a basic analysis of VA outcomes from the studies.…”

“…Upon screening using our pre-defined inclusion criteria, 143 were discarded after review of the publication titles, 27 were discarded after the review of publication abstracts, and a further 8 were discarded after the review of full text. No additional studies were identified through the review of reference lists within the publications we identified; however, we were aware of an important study (AURA) 20 that was not identified by the pre-defined search terms but was relevant to this review. Therefore, 20 studies in total were included in our evaluation.…”

“…The last few years saw several studies report that outcomes achieved with ranibizumab in clinical practice failed to match the efficacy observed in the early ranibizumab clinical trial programme upon which its license was granted. These include WAVE, 17 HELIOS, 18 LUMIERE, 19 AURA, 20 and the MEDISOFT database. 21 Interestingly, these studies showed VA gains of 3.8-6.7 letters during the most intensive treatment period (loading period), but unlike MARINA and ANCHOR, these initial visual outcomes were not maintained over time.…”