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

Autor: Sakamoto T; Department of Ophthalmology, Kagoshima University, 8-35-1 Sakuragaoka, Kagoshima, 890-8544, Japan. tsakamot@m3.kufm.kagoshima-u.ac.jp., Shimura M; Department of Ophthalmology, Tokyo Medical University Hachioji Medical Center, Tokyo, Japan., Kitano S; Diabetes Center, Tokyo Women's Medical University, Tokyo, Japan., Ohji M; Department of Ophthalmology, Shiga University of Medical Science, Otsu, Shiga, Japan., Ogura Y; Department of Ophthalmology and Visual Science, Nagoya City University, Nagoya, Aichi, Japan., Yamashita H; Department of Ophthalmology and Visual Sciences, Yamagata University, Yamagata, Japan., Suzaki M; Medical Division, Novartis Pharma K.K., Tokyo, Japan., Mori K; Medical Division, Novartis Pharma K.K., Tokyo, Japan., Ohashi Y; Medical Division, Novartis Pharma K.K., Tokyo, Japan., Yap PS; Novartis Corporation (M) Sdn. Bhd., Selangor, Malaysia., Kaneko T; Medical Division, Novartis Pharma K.K., Tokyo, Japan., Ishibashi T; Department of Ophthalmology, Kyushu University, Fukuoka, Japan.
Jazyk: angličtina
Zdroj: Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie [Graefes Arch Clin Exp Ophthalmol] 2022 Feb; Vol. 260 (2), pp. 477-487. Date of Electronic Publication: 2021 Sep 03.
DOI: 10.1007/s00417-021-05308-8
Abstrakt: 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.
(© 2021. The Author(s).)
Databáze: MEDLINE
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