Intravitreal Aflibercept for Treatment-Resistant Neovascular Age-related Macular Degeneration

Objective: To assess the effectiveness of intravitreal aflibercept in patients with neovascular age-related macular degeneration (AMD) previously resistant to treatment with other anti-vascular endothelial growth factor agents. Design: Prospective, open-label, noncontrolled, registered clinical trial. Participants: Forty-nine patients with treatment-resistant neovascular AMD. Intervention: A dose of 2 mg intravitreal aflibercept was administered as 3 initial loading doses every 4 weeks (week 0, week 4, and week 8), followed by further injections every 8 weeks (weeks 16 and 24) across a 24-week period in total. All patients underwent a complete ophthalmic examination, including measurement of Early Treatment Diabetic Retinopathy Study (ETDRS) best-corrected visual acuity (BCVA), intraocular pressure assessment, adverse event monitoring, and spectral-domain optical coherence tomography at every visit. Baseline fluorescein angiography and indocyanine green angiography also were performed. Main Outcome Measures: Outcomes assessed included proportions of patients with a gain or loss of more than 5 ETDRS letters and a decrease or increase in central retinal thickness (CRT) of more than 150 mu m at week 24 compared with baseline, change in mean BCVA and CRT between baseline and week 24, and descriptive safety data. Results: The BCVA improved and CRT was reduced significantly at all follow-up visits compared with baseline (P < 0.001), with a mean improvement of 6.9 letters of BCVA and a decrease of 89.4 mu m in CRT at week 24. Spacing of injections from every 4 weeks to 8 weeks resulted in an increase of 37.4 mu m in CRT (P < 0.001); however, this was not correlated with a significant change in vision. There was 1 (2%) patient who lost more than 5 ETDRS letters, and 27 (55%) patients who gained more than 5 letters. Two (4%) patients had a more than 150 mu m increase in CRT at week 24, and 10 (20%) patients showed a decrease in CRT of more than 150 mu m. Conclusions: Intravitreal aflibercept is effective in previously treatment-resistant neovascular AMD. Further follow-up is required to determine whether these improvements can be maintained. (C) 2014 by the American Academy of Ophthalmology.