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

Purpose: To 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. Methods: In 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. Results: Eyes 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. Conclusions: A 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.