TY - JOUR
T1 - Impact on visual acuity and psychological outcomes of ranibizumab and subsequent treatment for diabetic macular oedema in Japan (MERCURY)
AU - for the MERCURY Study Group
AU - Sakamoto, Taiji
AU - Shimura, Masahiko
AU - Kitano, Shigehiko
AU - Ohji, Masahito
AU - Ogura, Yuichiro
AU - Yamashita, Hidetoshi
AU - Suzaki, Makoto
AU - Mori, Kimie
AU - Ohashi, Yohei
AU - Yap, Poh Sin
AU - Kaneko, Takeumi
AU - Ishibashi, Tatsuro
N1 - Funding Information:
The authors thank all investigators who participated at each institute in this study. The authors also thank Michihiro Shono, a former employee of Novartis Pharma K.K. (Tokyo, Japan), Sadhu Sanchayita (Novartis Healthcare Pvt. Ltd., Hyderabad, India) and Rajendra Prasad Sarkar (Novartis Corporation Sdn. Bhd., Selangor, Malaysia), for preparing the study protocol and implementing the statistical analyses. We thank Sally-Anne Mitchell, PhD, of Edanz Pharma, for providing medical writing support, which was funded by Novartis Pharma K.K. through EMC K.K. in accordance with Good Publication Practice (GPP3) guidelines ( http://www.ismpp.org/gpp3 ).
Funding Information:
Taiji Sakamoto reports personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study; has worked as a consultant for Bayer (Osaka, Japan) and received personal fees; has received grant support from Chugai (Tokyo, Japan), Senju (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan) and Parexel (Tokyo, Japan); and has received personal fees (lecture fees) from Santen (Osaka, Japan), Bayer (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan), Alcon (Tokyo, Japan), Otsuka (Tokyo, Japan), Senju (Osaka, Japan), Kowa (Aichi, Japan), Wakamoto (Tokyo, Japan), MSD (Tokyo, Japan), Bausch & Lomb (Tokyo, Japan), Chuo Sangiyo (Hyogo, Japan), Japan Ophthalmic Instruments Association (Tokyo, Japan), Parexel (Tokyo, Japan), Nidek (Aichi, Japan), R E Medical (Osaka, Japan), KY CenterVue (Tokyo, Japan) and Chugai (Tokyo, Japan) outside the submitted work. Masahiko Shimura has received grant support from Novartis Pharma K.K. (Tokyo, Japan) and Bayer (Osaka, Japan) outside the submitted work. Shigehiko Kitano has received personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study; grant support from Novartis Pharma K.K. (Tokyo, Japan), Bayer (Osaka, Japan), Senju (Osaka, Japan), Santen (Osaka, Japan), Alcon (Tokyo, Japan) and Otsuka (Tokyo, Japan); and personal fees (lecture fees) from Novartis Pharma K.K. (Tokyo, Japan), Kowa (Aichi, Japan), MSD (Tokyo, Japan), Bayer (Osaka, Japan) and Novo Nordisk (Tokyo, Japan) outside the submitted work. Masahito Ohji has received personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study; personal fees for work as a consultant for Allergan (Tokyo, Japan), Bayer (Osaka, Japan), HOYA (Tokyo, Japan), Novartis Pharma K.K. (Tokyo, Japan), Chengdu Kanghong Biotechnology (Chengdu, China) and Alcon (Tokyo, Japan); grant support from Santen (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan), Alcon (Tokyo, Japan), Otsuka (Tokyo, Japan), Senju (Osaka, Japan), Pfizer (Tokyo, Japan), HOYA (Tokyo, Japan) and AMO (Tokyo, Japan); and personal fees (lecture fees) from Santen (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan), Bayer (Tokyo, Japan), Alcon (Tokyo, Japan), Otsuka (Tokyo, Japan), Kowa (Aichi, Japan) and Senju (Osaka, Japan) outside the submitted work. Yuichiro Ogura has received personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study; personal fees for work as a consultant for Bayer (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan), HOYA (Tokyo, Japan), Kowa (Aichi, Japan), Astellas (Tokyo, Japan), Janssen (Tokyo, Japan), Alcon (Tokyo, Japan), Graybug (CA, USA), Kyoto Drug Discovery & Development (Kyoto, Japan), Allergan (Tokyo, Japan) and Chugai (Tokyo, Japan); grant support from Boehringer Ingelheim (Tokyo, Japan) and Novartis Pharma K.K. (Tokyo, Japan); and personal fees (lecture fees) from Bayer (Osaka, Japan), Novartis Pharma K.K. (Tokyo, Japan), Santen (Osaka, Japan), Senju (Osaka, Japan), Sanwa Kagaku (Aichi, Japan), Wakamoto (Tokyo, Japan), Otsuka (Tokyo, Japan), Topcon (Tokyo, Japan) and Nikon (Tokyo, Japan) outside the submitted work. Hidetoshi Yamashita has received personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study; grant support from Novartis Pharma K.K. (Tokyo, Japan), Alcon (Tokyo, Japan), Santen (Osaka, Japan), Senju (Osaka, Japan), AMO (Tokyo, Japan), Trust Medical (Miyagi, Japan) and Atsuzawa Prosthesis (Tokyo, Japan); and personal fees (lecture fees) from Novartis Pharma K.K. (Tokyo, Japan), Santen (Osaka, Japan), Senju (Osaka, Japan), Bausch & Lomb (Tokyo, Japan) and Bayer (Osaka, Japan) outside the submitted work. Makoto Suzaki, Kimie Mori, Yohei Ohashi and Takeumi Kaneko are employees of Novartis Pharma K.K. (Tokyo, Japan). Poh Sin Yap is an employee of Novartis Corporation Sdn. Bhd. (Selangor, Malaysia). Tatsuro Ishibashi has received personal fees from Novartis Pharma K.K. (Tokyo, Japan) for this study and lecture fees from Santen (Osaka, Japan), Bayer (Osaka, Japan), Otsuka (Tokyo, Japan), Bausch & Lomb (Tokyo, Japan), Rohto (Osaka, Japan), Senju (Osaka, Japan) and Novartis Pharma K.K. (Tokyo, Japan) outside the submitted work.
Funding Information:
The authors thank all investigators who participated at each institute in this study. The authors also thank Michihiro Shono, a former employee of Novartis Pharma K.K. (Tokyo, Japan), Sadhu Sanchayita (Novartis Healthcare Pvt. Ltd., Hyderabad, India) and Rajendra Prasad Sarkar (Novartis Corporation Sdn. Bhd., Selangor, Malaysia), for preparing the study protocol and implementing the statistical analyses. We thank Sally-Anne Mitchell, PhD, of Edanz Pharma, for providing medical writing support, which was funded by Novartis Pharma K.K. through EMC K.K. in accordance with Good Publication Practice (GPP3) guidelines (http://www.ismpp.org/gpp3). The full list of the MERCURY study group investigators and advisors is provided in Online Resource 1.
Publisher Copyright:
© 2021, The Author(s).
PY - 2022/2
Y1 - 2022/2
N2 - 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. [Figure not available: see fulltext.]
AB - 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. [Figure not available: see fulltext.]
UR - http://www.scopus.com/inward/record.url?scp=85114367963&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85114367963&partnerID=8YFLogxK
U2 - 10.1007/s00417-021-05308-8
DO - 10.1007/s00417-021-05308-8
M3 - Article
C2 - 34477927
AN - SCOPUS:85114367963
SN - 0721-832X
VL - 260
SP - 477
EP - 487
JO - Graefe's Archive for Clinical and Experimental Ophthalmology
JF - Graefe's Archive for Clinical and Experimental Ophthalmology
IS - 2
ER -
