2-Year Results of the PLANET Study: Intravitreal Aflibercept Alone and With Rescue Photodynamic Therapy in Polypoidal Choroidal Vasculopathy

Abstract

Purpose : The aim of the PLANET study was to evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) compared with IAI plus rescue photodynamic therapy (PDT) in patients with polypoidal choroidal vasculopathy (PCV) over 2 years.

Methods : PLANET was a randomized, double-masked, sham-controlled, Phase 3b/4 study conducted at 62 sites primarily in Asia. All patients received IAI 2 mg monthly for the first 3 months. At Week 12, all patients were randomized 1:1 to IAI 2mg + sham PDT (IAI monotherapy) or IAI 2mg + active rescue PDT. Patients who did not require rescue therapy were treated with IAI 2mg every 8 weeks; patients who required rescue received IAI 2mg + active/sham PDT every 4 weeks until rescue criteria were no longer met. From Week 52 to Week 96, patients not meeting rescue criteria could have their treatment intervals gradually extended. Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline to Week 52.

Results : Overall 318 patients were randomized and treated (full analysis set). 83% of patients did not qualify for rescue treatment. At Week 96, mean change in BCVA for IAI monotherapy was noninferior (5-letter margin) to IAI+rescue PDT for the total (10.7 vs 9.1 letters [n=318]; 95% CI, –1.7 to 3.6) and rescue populations (2.6 vs 0.0 letters [n=54]; 95% CI, –3.9 to 9.7). Mean change in central subfield thickness in the IAI monotherapy and IAI+rescue PDT groups was –140.0 µm and –135.4 µm in the total population and –150.9 µm and –171.7 µm in the rescue population, respectively. The proportion of patients with complete polyp regression in the IAI monotherapy and IAI+rescue PDT groups was 33.1% and 29.1% in the total population and 25.0% and 26.1% in the rescue population, respectively. The proportion of patients without active polyps in the IAI monotherapy and IAI+rescue PDT groups was 82.1% and 85.6% in the total population and 90.0% and 80.0% in the rescue population, respectively. Most frequent ocular adverse events were conjunctival hemorrhage (6.4%) and dry eye (6.8%) in the IAI monotherapy and IAI+rescue PDT groups, respectively.

Conclusions : After 2 years, IAI monotherapy was effective for the majority of patients with PCV; rescue PDT did not provide additional functional or anatomical benefits. The safety data were consistent with the known safety profile of IAI.

This is an abstract that was submitted for the 2018 ARVO Annual Meeting, held in Honolulu, Hawaii, April 29 - May 3, 2018.