Impact on visual acuity and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY)

Abstract

Purpose The MERCURY study aimed to evaluate the effects on visual acuity and psychological symptoms, and safety, of ranibizumab and subsequent treatment in patients with diabetic macular oedema (DME) and impaired visual acuity (VA). We report data from the prespecified 12-month interim analysis. Methods This was a 24-month, phase 4, open-label, single-arm, prospective, observational study conducted at 20 specialised retinal centres in Japan. Participants were 209 patients with DME and impaired VA, not previously treated with either intravitreal or systemic anti-vascular endothelial growth factor (anti-VEGF) agents, who initiated ranibizumab 0.5 mg per investigator discretion. Following ranibizumab administration, patients were treated per routine clinical practice. Other treatments were allowed. The main outcome measure was the mean change in best-corrected VA (BCVA) in logarithmic minimum angle of resolution (logMAR) from baseline to month 12. An exploratory objective was to assess patients’ psychological status using the Hospital Anxiety and Depression Scale (HADS). Results The mean ± standard deviation BCVA at baseline was 0.43 ± 0.39 logMAR. The mean number of injections of ranibizumab and anti-VEGF agents from baseline to month 11 was 3.2 ± 2.0 and 3.6 ± 2.4, respectively. The BCVA change from baseline to 12 months was − 0.08 ± 0.34 logMAR (p = 0.011), showing a significant improvement; the HADS-anxiety score also decreased significantly (p = 0.001) and the depression score decreased numerically (p = 0.080). Conclusion MERCURY study data confirm the effectiveness of real-world treatment initiated with ranibizumab in Japanese patients with DME. In addition, treatment was able to positively influence anxiety via VA improvement.

Progress of Diabetic Macular Edema after Loading Injection of Anti-Vascular Endothelial Growth Factor Agents in Real-World Cases

“…More frequent injections were associated with vision improvement, especially with loading injections [ 16 ]. The results of the MERCURY study, which analyzed the actual clinical data of ranibizumab for DME treatment in Japan, also showed the importance of the loading injection in improving BCVA [ 17 ]. In our study, almost 20% of the patients could maintain a CRT of ≤350 μm for 6 months after the loading injection alone; which suggests that the loading injection contributed to the improvement in BCVA.…”

The Impact of Interval between Recurrence and Reinjection in Anti-VEGF Therapy for Diabetic Macular Edema in Pro Re Nata Regimen

“…Similar to the results of our study, a higher number of injections showed a better visual prognosis. In Japan, the number of injections of anti-VEGF drugs has been increasing every year, from 2.5 ± 1.8 injections in the two-year period from 2010-2012 to 5.5 ± 3.6 injections in 2015-2017 [19]. The number of injections is expected to increase further in the future, and still, the timing of injections for recurrence should not be delayed.…”

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

“…The MERCURY study was a 24-month, phase 4, open-label, single-arm, multicentre, prospective, observational study conducted in Japan from April 2017 to December 2020. 15 Data were collected using electronic case report forms, and patients were discontinued from the study if they had not attended ophthalmology study visits at least once a year, withdrew consent or for other reasons.…”

“…Details of the statistical analyses have been published previously. 15 The target sample size was 200 patients based on the results of previous studies. 14 19 Descriptive statistics were used for analysis, and estimates and corresponding 95% CIs were calculated.…”

“…The MERCURY study examined the long-term effectiveness and safety of ranibizumab and subsequent therapy in Japanese patients with DME with impaired VA and evaluated the psychological effects associated with expected outcomes (VA improvements) after anti-VEGF treatment in patients with DME in the real-world setting. The 12-month interim results have been published, 15 and after 12 months of treatment, the mean best-corrected VA (BCVA) had significantly improved, and while patients’ depression scores had not improved, they had significantly decreased anxiety scores. Here, we report the 2-year visual and psychological outcomes of the MERCURY study, evaluating ranibizumab and subsequent treatment for DME in Japan.…”