Three-Year Real World Outcomes of Aflibercept Treatment of Treatment-naïve Patients with Neovascular Age-related Macular Degeneration

Abstract

Purpose : To report outcomes 3 year aflibercept (Eylea^® Bayer Pharma, Germany) treatment outcomes for neovascular age related macular degeneration (nAMD) in a clinical setting.

Methods : This is a retrospective, observational study with 36 ± 2 months follow up of consecutive treated, treatment naïve patients with nAMD. Treatment was started following NICE (National Institute for Health and Care Excellence) guidance for funding treatment, which included visual acuity (VA) between 24 and 73 ETDRS letters and initiated between 1/10/2013 and 31/12/2013. Aflibercept was administrated 2 monthly for the first year after 3 initial monthly injections and in a treat and extend regimen for the second year onwards. According to the Moorfields AMD protocol if CNV was inactive at each of 4 consecutive 12 weekly treatments in year 2 treatment was discontinued. Exclusion criteria were: ≤4 intravitreal injections in year 1, absence of VA at baseline or final visit and concomitant ocular conditions that could affect the final outcome. The primary outcome was the percentage of patients who maintained VA (loss of <15 ETDRS letters from baseline) at 3 years and the percentage of patients with active disease at the end of the follow up period. Secondary outcomes included mean changes in VA and optical coherence tomography (OCT) derived central macular thickness (CMT) over time.

Results : Data from 85 eyes of 79 patients were available at 3 year follow-up. Mean age was 77.5 ± 8 years and the median number of injections was 15, with a median of 8, 4 and 4 for years 1, 2 and 3 respectively. At year 3, 85% of patients maintained VA. 58.8% still had active disease requiring treatment with a treat and extent regimen and in 41.2% treatment was discontinued according to stability criteria. VA improved from (mean ± standard deviation) 55.5 ± 14.9 letters at baseline to 61 ± 17.1 letters at year 1 (5.5 ± 15 letter gain); 61.6 ± 17 letter score at year 2 (5 ± 14.9 letter gain) and 58.3 ± 17.6 letter score (2.7 ± 17.6 letter gain) at year 3.The mean reduction in CMT from baseline was 83.8 ± 91.1µm, 88.6 ± 94.3 µm and 87.5 ± 98.2 µm at 1, 2 and 3 years respectively.

Conclusions : The VA gain following aflibercept use for nAMD in clinical practice as per the Moorfields nAMD protocol persists into year 3 of treatment. However, ongoing treatment is still required in patients with persistent disease activity.

This is an abstract that was submitted for the 2017 ARVO Annual Meeting, held in Baltimore, MD, May 7-11, 2017.