Ozurdex in age-related macular degeneration as adjunct to ranibizumab (The OARA Study)

Objective: To evaluate the utility of dexamethasone intravitreal implant (DXI; Ozurdex; Allergan, Irvine, Calif.) in combination with ranibizumab (Lucentis; Novartis Pharma AG, Basel, Switzerland) versus ranibizumab monotherapy on visual acuity (VA) and anatomical outcomes in a neovascular age-related macular degeneration (nAMD) cohort. Design: Multicentred, single-blinded, pilot randomized control trial. Participants: Ten patients 50 years or older with subfoveal choroidal neovascularization secondary to AMD were randomized to receive DXI in combination with ranibizumab (group 1) or ranibizumab alone (group 2) after a 3-month ranibizumab loading period. Methods: Group 1 patients received 1 DXI after the loading phase with the option of retreatment at months 4 to 6. Ranibizumab was administered pro re nata for 6 months in both study arms. Mean VA and central macular thickness (CMT) reductions from baseline to study endpoint (9 months) were reported in addition to adverse event frequency across study cohorts. Results: From baseline to the study endpoint, VA improved by 10.8 +/- 13.2 Early Treatment of Diabetic Retinopathy Study letters in the control arm and 3.0 +/- 10.5 letters in the intervention arm (p = 0.331). CMT decreased by 31.7% +/- 17.5% and 13.3% +/- 27.0% (p = 0.236) for the control and intervention cohorts, respectively. One patient developed intraocular pressure in excess of 30 mm Hg 3 months after DXI administration. Conclusions: For this nAMD population, no visual or anatomical benefits were observed when treating with DXI in adjunct to ranibizumab relative to ranibizumab monotherapy. DXI-related adverse events were consistent with those previously documented for dexamethasone.