Two-year visual and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY)

Taiji Sakamoto, Masahiko Shimura, Shigehiko Kitano, Masahito Ohji, Yuichiro Ogura, Hidetoshi Yamashita, Makoto Suzaki, Kimie Mori, Masanari Kozawa, Poh Sin Yap, Takeumi Kaneko, Tatsuro Ishibashi

Research output: Contribution to journalArticlepeer-review

Abstract

Objective We 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 analysis This 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. Results In 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. Conclusions At 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.

Original languageEnglish
Article number001069
JournalBMJ Open Ophthalmology
Volume7
Issue number1
DOIs
Publication statusPublished - Oct 28 2022

All Science Journal Classification (ASJC) codes

  • Ophthalmology

Fingerprint

Dive into the research topics of 'Two-year visual and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY)'. Together they form a unique fingerprint.

Cite this