Paul Mitchell AO1,2, Tomohiro Iida3, Yuichiro Ogura4, Shih Jen Chen5, Tien Yin Wong6,7, Eric Zhang8, Sergio Leal8, Tatsuro Ishibashi9, Gemmy Cheung6,7, Won Ki Lee10
Purpose: To compare efﬁcacy and safety of intravi- treal aﬂibercept (IVT-AFL) versus IVT-AFL plus res- cue PDT in patients with polypoidal choroidal vasculopathy (PCV).
Methods: PLANET was a 96-week, randomised, double-masked, sham-controlled, multicentre, Phase 3b/4 study. All patients received 3 monthly injec- tions of IVT-AFL 2 mg; at Week 12 (W12), patients were randomised to IVT-AFL plus sham PDT (IVT- AFL monotherapy) or IVT-AFL plus active rescue PDT. Patients not requiring rescue received IVT- AFL every 8 weeks. Patients requiring rescue received IVT-AFL every 4 weeks plus active/sham PDT according to local label. From W52, patients not requiring rescue could have treatment intervals extended by 1- to 2-week increments at investiga- tor’s discretion. Primary endpoint was mean BCVA change at W52. Here, we report W96 results.
Results: Mean BCVA change with IVT-AFL mono- therapy was non-inferior to IVT-AFL plus rescue PDT overall (+10.7 vs +9.1 letters [n = 318]) and in patients requiring rescue (+2.6 vs +0.0 letters [n = 54]). Mean CST change was –140.0 μm (overall) and
–135.4 μm (rescue population). Proportions of patients with complete polyp regression and with- out active polyps were 33.1% and 82.1% (overall) and 29.1% and 85.6% (rescue population). Both groups received a mean of 8.1 (baseline to W52) and
4.6 (W52 to W96) injections. Most frequent ocular adverse events were conjunctival haemorrhage (6.4%; IVT-AFL monotherapy) and dry eye (6.8%; IVT-AFL plus rescue PDT groups).
Conclusions: After 2 years, IVT-AFL monotherapy was effective for most PCV patients; rescue PDT did not provide additional functional or anatomical beneﬁts.
COMPARISON OF RANIBIZUMAB AND AFLIBERCEPT IN PATIENTS WITH NEOVASCULAR AGE-RELATED MACULAR DEGENERATION TREATED FOLLOWING A ?TREAT AND EXTEND? PROTOCOL: EFFICACY VARIABLES FROM THE PRE-SPECIFIED 12- MONTH INTERIM ANALYSIS OF THE RIVAL STUDY