Treat-and-Extend Therapy Using Aflibercept for Neovascular Age-related Macular Degeneration: A Prospective Clinical Trial.
To determine the efficacy and durability of aflibercept used in a treat-and-extend (TAE) regimen for neovascular age-related macular degeneration (NVAMD). Multicenter, prospective, open label, noncomparative, interventional study. Forty eyes of 40 patients with treatment-naïve NVAMD were managed with a TAE regimen of intravitreal aflibercept. The main endpoints were the change in mean and median best-corrected visual acuity from baseline at years 1 and 2. Other endpoints included mean number of annual injections and treatment intervals. Thirty-five (87.5%) and 31 patients (77.5%) completed year 1 and year 2, respectively. The mean letter gain was 7.2 (P < .001) and 2.4 (P = .269) letters at 1 and 2 years, respectively, from a mean baseline of 58.9 letters (20/63 Snellen equivalent). The median visual gain was 11.5 and 7.5 letters at 1 and 2 years, respectively, from a median baseline of 59.0 letters (20/63 Snellen equivalent). The mean number of injections was 8.0 and 6.5 during the first and second year, respectively. Twelve-week or longer treatment intervals were used in 35% and 38% of patients during the first- and second-year time points, respectively. Intravitreal aflibercept TAE therapy led to significant visual improvement in eyes with NVAMD at 1 year, with some loss in the visual gains at the end of year 2 that was not related to loss of exudative control. TAE therapy with aflibercept is a rational strategy to reduce treatments and clinic evaluations over 2 years with satisfactory outcomes.