Introduction
It is estimated that 69 million adults in Europe will have age-related macular degeneration (AMD) by 2040.1 Most vision loss associated with AMD is caused by the neovascular/wet form of the disease.2 Anti-vascular endothelial growth factor (VEGF) agents have become increasingly popular in the treatment of this form of AMD. Intravitreal aflibercept (IVT-AFL) was approved for use in wet AMD in Europe in 2012, with bimonthly dosing (after three initial doses) and extension after 12 months. IVT-AFL is known to target VEGF and placental growth factor, which are key mediators in the progression of neovascularisation underlying wet AMD.3 4 IVT-AFL 2 mg every 8 weeks (2q8) after three initial doses was shown to be noninferior to ranibizumab 0.5 mg monthly, with comparable ocular safety, in the VIEW studies.5 6 However, the results achieved under strict protocols in randomised studies may not always be achieved in routine practice; this has prompted an interest in real-world studies.
Most published observational studies have largely been in patients treated with ranibizumab, mainly due to its earlier European approval in 2007. Ranibizumab 0.5 mg was initially approved with monthly or as-needed dosing after a loading dose (induction) coupled with regular monitoring. However, these regimens may have contributed to underdosing in clinical practice; this has been reported in several large-scale studies.7–9
The aim of this is to report the 12-month outcomes from the RAINBOW (Real life use of intravitreal Aflibercept In FraNce - oBservatiOnal study in Wet age-related macular degeneration) study. RAINBOW is an observational study to monitor the effectiveness and safety of IVT-AFL when used in treatment-naïve patients with wet AMD in routine clinical practices across France.