Intravitreal Aflibercept for Treatment-Resistant Neovascular Age-related Macular Degeneration Patients: 3-Year Outcomes

Abstract

Purpose : Long-term safety and efficacy of intravitreal aflibercept on treatment-resistant neovascular age-related macular degeneration (TR-nAMD) patients is unknown. We prospectively evaluate the efficacy and safety of intravitreal aflibercept over 3-years.

Methods : Forty-nine TR-nAMD patients aged over 50 years were treated with three monthly loading doses of intravitreal aflibercept followed by injections every 8 weeks across 48-weeks. Subsequently, a spectral-domain optical coherence tomography (SD-OCT) guided “as-needed” regime was given for a further 2-years. Ophthalmic examinations included best-corrected visual acuity (BCVA) assessed in Early Treatment of Diabetic Retinopathy Study charts and central macular thickness (CMT) measured by SD-OCT at each visit. Changes in BCVA and CMT were analysed using paired t-test, Pearson’s correlation and linear regression methods.

Results : Mean BCVA at baseline was 60.5±16.2 letters and this improved significantly over the 1^st year by 4.7±9.1 letters (p<0.001), and maintained up to years-2 and 3 (changes of 0.8±9.2 letters, p=0.573 and 1.1±10.0 letters, p=0.535), compared to baseline. Mean CMT at baseline was 448.4±141.2μm, which reduced significantly at years-1, 2, and 3 by 97.2±149.3µm, 144.0±149.7µm and 142.2±158.9µm, (p<0.001, for all), compared to baseline. BCVA improvements correlated with CMT changes at week-24 only (r=-0.295, p=0.039). Mean number of injections and visits over 1^st year were 7.0±0.0 and 13.0±0.0. Mean injection numbers increased by 0.7±2.1, (p=0.031) and 1.5±3.1, (p=0.003) while visit numbers decreased by -3.8±1.8 and -4.0±3.0, (all p<0.001) over 2^nd and 3^rd years compared to baseline. There were no significant systemic and ocular safety issues found over 3-years of treatment. Cardiovascular related severe adverse events were myocardial infarction (1%), atrial fibrillation (2%), deep vein thrombosis (2%), mini stroke (2%) and heart attack (2%). Ocular adverse events over 3-years of treatment in study eye were sub-macular haemorrhage (2%) and intraocular pressures elevation >25mmHg (4%).

Conclusions : Aflibercept has been suggested to be effective in anatomical improvement and maintaining vision in TR-nAMD patients over 3-years. Vision improvement in first 24-weeks may relate to the reduction in macular oedema. Intravitreal aflibercept appears safe to use over 3-year treatment.

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