One-year Outcomes following Intravitreal Aflibercept for Polypoidal Choroidal Vasculopathy in Japanese Patients: The APOLLO study

Abstract

Purpose : To evaluate one-year outcomes of intravitreal injection of aflibercept (IVA) in patients with polypoidal choroidal vasculopathy (PCV) in Japanese patients.

Methods : In this prospective, open-label, single-arm multicenter clinical trial, treatment naïve patients with PCV received intravitreal aflibercept (2.0 mg) every two months, after three initial monthly doses. The primary end point assessed was the proportion of patients maintaining baseline best-corrected visual acuity (BCVA) at one-year. BCVA change of 0.3 or more in log MAR VA was considered significant. Worsening in BCVA was defined as a decrease of > 0.3 log MAR units. Other key end points included change in BCVA and anatomic measures (Fisher’s extract test).

Results : Fifty eyes with PCV were included in this study. The proportions of patients with significant log MAR VA improvement or maintained was 97.6%. Mean Log MAR BCVA at baseline was 0.33 and improved to 0.12 Log MAR after one-year aflibercept treatment (p<0.001). The average central foveal thickness decreased from 356μm to 239μm (p<0.001). Complete regression rate of polypoidal lesions was seen in 54.8% after six months of treatment, and 72.5% after one-year of treatment. Ocular and systemic adverse events were encountered in six cases (herpetic keratitis 2%, subretinal hemorrhage 2%).

Conclusions : IVA is well tolerated in eyes with Japanese PCV patients. One-year outcomes of aflibercept treatment for Japanese patients with PCV resulted in stabilization of visual acuity accompanied by anatomical improvement. IVA monotherapy is effective for PCV patients with complete regression of polypoidal lesion.

This is an abstract that was submitted for the 2016 ARVO Annual Meeting, held in Seattle, Wash., May 1-5, 2016.