Paul Mitchell AO1,2, Eric Souied3, Edoardo Midena4, Frank G. Holz5, Philip Hykin6, Sebastian Wolf7, Helmut Allmeier8
Purpose: To assess whether intravitreal aﬂibercept (IVT-AFL) administered in an early-start treat-and- extend (T&E) regimen (initiated after the ﬁrst 8-week treatment interval) is non-inferior to IVT- AFL administered in a late-start T&E regimen (initi- ated at the end of Year 1, per label) in patients with nAMD.
Methods: ARIES is a multicentre, randomised, open-label, active-controlled, parallel-group, Phase 4 study. All patients received 3 initial monthly doses of IVT-AFL (Weeks 0, 4, 8), followed by a subse- quent injection at an 8-week treatment interval (Week 16). At Week 16, patients were randomised 1:1 to early-start T&E (T&E regimen extended by
2 weeks or an initial 4-week interval [maximum
16 weeks]) or late-start T&E (per label: IVT-AFL 2q8 regimen). The primary endpoint is the mean change in BCVA (ETDRS letter score) from rando- misation to Week 104. Here we present baseline data.
Results: A total of 287 treatment-naïve patients with nAMD were enrolled. At Week 16, 271 patients were randomised to an early- or late-start T&E regimen. Mean age was 76.5 years; 64.9% patients were aged ≥75 years. Mean baseline BCVA was 60.4 ETDRS letters; proportions of patients with baseline BCVA < 35, >35– < 70, and ≥70 letters were 6.3%, 63.8%, and 29.9%, respectively (n = 271). Mean baseline CRT was 472.9 μm (n = 270); it was >300 μm in most patients (n = 251, 92.6%).
Conclusions: This Phase 4 study will compare the efﬁcacy of IVT-AFL, administered by either an early-start or a late-start T&E regimen, in patients with nAMD.