Original articleThe SECURE Study: Long-Term Safety of Ranibizumab 0.5 mg in Neovascular Age-related Macular Degeneration
Section snippets
Study Design
SECURE was a 24-month, prospective, multicenter, phase IV, open-label extension study in patients with subfoveal CNV secondary to AMD who previously were treated for 1 year in either of the 2 ranibizumab studies EXCITE15 or SUSTAIN.16 The EXCITE and SUSTAIN studies were designed to assess the efficacy of alternate dosing regimens of ranibizumab. Thus, all patients received ranibizumab in the previous EXCITE (mean of approximately 5.5 ranibizumab injections in the quarterly treatment arms and
Patient Disposition and Demographics
A total of 134 of 353 EXCITE patients and 100 of 531 SUSTAIN patients who provided signed informed consent (n = 234) were enrolled in the SECURE study (Fig 1). The safety set consisted of 234 patients, and the FAS consisted of 233 patients (1 patient did not have a postbaseline VA assessment and was excluded from the FAS). Of the 234 enrolled patients, 210 (89.7%) completed the study (Table 1). The most common reasons for study discontinuation were AEs (3.4%), withdrawal of consent (3.4%), and
Discussion
The SECURE study was designed as a long-term extension study primarily to evaluate the safety of ranibizumab in patients who previously had been treated with ranibizumab for 1 year in the EXCITE or SUSTAIN studies. Results indicate that ranibizumab administered for 2 years of extension after 1 year of initial treatment was associated with a low incidence of ocular and nonocular AEs and SAEs. There were no new ocular or nonocular safety findings compared with the European Union SmPC18 for
Acknowledgments
The authors thank Sushmita Bhattacharya for assistance in developing the initial draft of the manuscript, Aditi Gandhe for medical writing and editorial support for the manuscript, and Mohammed Najeeb Ashraf for revision and resubmission support in all subsequent drafts of the manuscript, all from Medical Communications, Novartis Healthcare Private Ltd, Hyderabad, India. The authors also thank Martin Neuner-Jehle, Novartis Pharma AG, Basel, Switzerland, for coordinating the development of this
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Manuscript no. 2011-1298.
Appendix: 1 contains a list of the primary investigators who participated in this study (available at http://aaojournal.org).
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Rufino Silva: Financial Support — International Advisory Board Member, Allergan, Pfizer, Novartis; THEA, Bayer.
Bora Eldem: Financial support, advisory board - Novartis, Pfizer, Allergan, Bayer, and Bausch & Lomb.
Robyn Guymer: Australian Advisory board — Novartis and Bayer.
Margarita Gekkieva: Employee — Novartis Pharma AG Switzerland.
Annette Nieweg: Employee — Novartis Pharma AG Switzerland.
Stefan Pilz: Employee — Novartis Pharma AG Switzerland.
Sponsored by Novartis Pharma AG, Basel, Switzerland, which participated in the design of the study; conducting the study; data collection; management, analysis, and interpretation of the data; and preparation, review, or approval of the manuscript. The study is registered with www.clinicaltrial.gov under number NCT00504959. Proprietary or commercial disclosure may be found after the references.