ABSTRACT NUMBER - 111

INTRAVITREAL AFLIBERCEPT WITH AND WITHOUT RESCUE PHOTODYNAMIC THERAPY IN POLYPOIDAL CHOROIDAL VASCULOPATHY: 2-YEAR RESULTS OF THE PLANET STUDY


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

Meeting:  2018 RANZCO


SESSION INFORMATION

Date:      -

Session Title: POSTER ABSTRACT- RETINA

Session Time:      -

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.

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