Abstract
PurposeThe 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.MethodsThis 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).ResultsThe 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).ConclusionMERCURY 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.
Highlights
Diabetic macular oedema (DME) is the most common cause of vision loss in patients with diabetes [1]
Studies have indicated that the severity of diabetic retinopathy and/or DME may be associated with poor psychosocial functioning [12] and an elevated level of depression [11]
Poor visual acuity (VA) in the better eye (BE) has been linked with anxiety and/or depression in other diseases of the eye, including age-related macular degeneration [13, 14] and glaucoma [15]. This is consistent with data which indicate that, in older adults, visual impairment in the BE is associated with a high prevalence of anxiety and depression, compared with normally-sighted peers [16]
Summary
Diabetic macular oedema (DME) is the most common cause of vision loss in patients with diabetes [1]. Poor visual acuity (VA) in the better eye (BE) has been linked with anxiety and/or depression in other diseases of the eye, including age-related macular degeneration [13, 14] and glaucoma [15]. This is consistent with data which indicate that, in older adults, visual impairment in the BE is associated with a high prevalence of anxiety and depression (measured using HADS and other psychological assessments), compared with normally-sighted peers [16]
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