Abstract
ObjectiveWe report the 2-year visual and psychological outcomes of the MERCURY study, examining the long-term effectiveness and safety of ranibizumab and subsequent therapy in Japanese patients with diabetic macular oedema with impaired visual acuity (VA) in the real-world setting.Methods and analysisThis was a 24-month, phase 4, open-label, single-arm, multicentre, prospective, observational study. Following an initial dose of ranibizumab (0.5 mg) by intravitreal injection (0.05 mL), treatment was administered as needed after month 1. The primary treated eye (PTE) was the first eye that received a ranibizumab injection.ResultsIn total, 209 patients were enrolled; 192 (91.9%) and 174 (83.3%) completed months 12 and 24, respectively. In the PTE set, mean±SD changes in best-corrected VA (BCVA) from baseline to months 12 (primary endpoint) and 24 were −0.08±0.35 (p=0.015) and −0.13±0.30 (p<0.001) logarithmic minimum angle of resolution, respectively. Mean±SD central subfoveal thickness (CSFT) changes from baseline to months 12 and 24 were −102.3±146.1 µm (p<0.001) and −103.6±157.2 µm (p<0.001), respectively. Patients receiving three injections during the first 2 months had greater BCVA improvements throughout the study than those receiving 1–2 consecutive injections. Overall, 91 (43.5%) and 130 (62.2%) patients had ocular and non-ocular adverse events, respectively. At month 24, the mean±SD Hospital Anxiety and Depression Scale (HADS)-Anxiety and HADS-Depression scores decreased by 0.44±3.75 (p=0.196) and 0.19±3.38 (p=0.541), respectively.ConclusionsAt 24 months after initiation of ranibizumab and subsequent treatment, patients showed significant BCVA and CSFT improvements. Long-term treatment was considered safe and tolerable and did not lead to worsened psychological status.