Original articleRanibizumab 0.5 mg for Diabetic Macular Edema with Bimonthly Monitoring after a Phase of Initial Treatment: 18-Month, Multicenter, Phase IIIB RELIGHT Study
Section snippets
Study Design
RELIGHT was an 18-month, prospective, open-label, multicenter, single-arm, phase III study of patients in the United Kingdom with visual impairment due to DME using a bimonthly follow-up and treatment protocol after a 6-month period of monthly monitoring. The study was conducted between January 2011 and April 2013 in accordance with the Declaration of Helsinki. The study protocol was reviewed and approved by a multicenter research ethics committee for each contributing center. Patients provided
Participant Disposition and Demographics
Of 109 enrolled participants, 100 (91.7%) and 99 (90.8%) completed 12 and 18 months of the study, respectively. The main reasons for discontinuation were AEs (3.7%), consent withdrawal, and loss to follow-up (1.8% each) (Fig 2). The efficacy and safety analyses were performed on the FAS and safety set, respectively, consisting of 109 participants. The mean age was 63.7 years, and the majority of participants were male (70.6%). Ninety-three participants (85.3%) were white patients, and 84.4% of
Discussion
The RELIGHT study demonstrated that 12 months of bimonthly PRN treatment with ranibizumab, after a treatment period of 3 initial doses followed by 3 monthly visits with PRN treatment, was able to maintain the initial mean VA improvements in participants with visual impairment due to DME. There were no new safety findings reported in this study.
With monthly monitoring from months 3 to 5 and bimonthly monitoring from months 6 to 18, plus PRN treatment, participants gained on average +4.8 letters
Acknowledgments
The authors thank Sabyasachi Ghosh and Aditi Gandhe (Global Business Services-Global Medical and Clinical Services, Novartis Healthcare Pvt. Ltd., Hyderabad, India) and Sue Lupton (Novartis Pharmaceuticals UK Ltd., Surrey, United Kingdom) for medical writing and editorial assistance toward the development of this article.
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∗Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
I.P.: Consultant for Allergan and Alimera; Consultant and lecturer − Novartis and Bayer.
S.B.: Received grants and personal fees − Novartis, Bayer, and Allergan (outside the submitted work).
B.J.L.B.: Financial support for attending conferences and worked as an advisor – Novartis; Personal fees − Bayer.
U.C.: Travel support for attendance at meetings and honoraria for attendance at advisory boards − Novartis, Roche, Allergan.
L.D.: Consultant – Novartis, Bayer, Allergan, Alcon, Alimera, Oraya and Thrombogenics; Travel grants- Novartis, Bayer, Allergan and Principal Investigator for Clincial Trials sponsored by Novartis and Allergan.
R.P.G.: Consultant and received educational grants − Novartis, and his institution performs clinical trials sponsored by Novartis.
J.G.: Consultant − Novartis Pharmaceuticals UK Ltd., Allergan Ltd., and Bayer PLC; received travel support and research funding − Novartis Pharmaceuticals UK Ltd.
S.P.: Consultant – Bayer, Novartis; Grant support – Novartis; Educational sponsorship to conferences − Allergan, Novartis, Alcon; Paid Speaker for Heidelberg Engineering in the year 2015.
S.S.: Research grants and travel grants, advisory board − Allergen, Bayer, Novartis, Roche.
C.A. and J.W.: Employees − Novartis Pharmaceuticals UK Ltd.
C.B.: Employee − Novartis Pharmaceuticals UK Ltd., when the manuscript was developed; currently is an employee of F. Hoffmann-La Roche Ltd., Basel, Switzerland.
The study was conducted in the United Kingdom and was funded and managed by Novartis Pharmaceutical UK and is registered with www.clinicaltrials.gov (NCT01257815).
Author Contributions:
Conception and design: Pearce, Banerjee, Burton, Chakravarthy, Downey, Gale, Gibson, Pagliarini, Patel, Sivaprasad, Andrews, Brittain, Warburton, RELIGHT Study Group
Data collection: Pearce, Banerjee, Burton, Chakravarthy, Downey, Gale, Gibson, Pagliarini, Patel, Sivaprasad, Andrews, Brittain, Warburton, RELIGHT Study Group
Analysis and interpretation: Pearce, Banerjee, Burton, Chakravarthy, Downey, Gale, Gibson, Pagliarini, Patel, Sivaprasad, Andrews, Brittain, Warburton, RELIGHT Study Group
Obtained funding: Not applicable
Overall responsibility: Pearce, Banerjee, Burton, Chakravarthy, Downey, Gale, Gibson, Pagliarini, Patel, Sivaprasad, Andrews, Brittain, Warburton, RELIGHT Study Group
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Group members are listed online in Appendix 1 (available at www.aaojournal.org).