Dexamethasone intravitreal implant combined with anti‐VEGF in patients with neovascular age related macular degeneration resistant to anti‐VEGF alone

Abstract

PurposeTo evaluate the efficacy and safety of a single intravitreal Dexamethasone implant (DXI) combined with anti‐vascular endothelial growth factor (anti‐VEGF) therapy, in patients with neovascular age related macular degeneration (wet‐AMD) resistant to the conventional treatment.MethodsIn this prospective, randomized, controlled pilot study 16 eyes of 15 patients, unresponsive to previous anti‐VEGF therapy, were enrolled. Patients were randomly assigned to three groups: DXI + Pro Re Nata (PRN) anti‐VEGF, DXI + monthly anti‐VEGF, and monthly anti‐VEGF alone. Each patient was treated at baseline, according to the assigned treatment, and followed up to 180 days. Primary outcomes were: complete regression of retinal fluid and best corrected visual acuity (BCVA) change. Secondary outcomes were: safety of the treatment, the change of median central foveal thickness (CFT) and macular volume. Correlations between anatomical features and visual function were also assessed.ResultsEyes distribution was: 5 in DXI + anti VEGF PRN; 6 in DXI + monthly anti‐VEGF (treatment group), and 5 in monthly anti‐VEGF. BCVA showed no significant change from baseline in both the treatment and control group. Eight eyes (72.7%) in the treatment group showed complete retinal fluid resorption versus 2 eyes (40%) in the control group (p = 0.049). Both median CFT and macular volume showed a greater reduction from baseline in the treatment group. BCVA significantly correlated with the outer retinal layers status (rho = 0.82; p = 0.0001) and pattern of retinal fluid (rho = −0.59, p = 0.02). Several eyes in the treatment group experienced a transient increase of the intraocular pressure.ConclusionsA combined approach with DXI and intravitreal anti‐VEGF may be a feasible option for those wet‐AMD patients with an incomplete response to anti‐VEGF therapy.