Original articleA Phase IIIb Study to Evaluate the Safety of Ranibizumab in Subjects with Neovascular Age-related Macular Degeneration
Section snippets
Materials and Methods
SAILOR was a 12-month, multicenter, phase IIIb study intended to further characterize the safety and efficacy profiles of intravitreal ranibizumab. Protocols were approved by the institutional review board at each study site, and the study was conducted according to the International Conference on Harmonisation E6 Guideline for Good Clinical Practice and any national requirements. All subjects provided informed consent before participation in the study. The SAILOR study is registered at //www.clinicaltrials.gov
Results
From November 2005 to June 30, 2006 (when ranibizumab was approved for the treatment of neovascular AMD by the Food and Drug Administration), 2378 cohort 1 subjects were randomly assigned to receive 0.3 mg (n = 1169) or 0.5 mg (n = 1209) intravitreal ranibizumab at 105 US centers. Cohort 1 subjects had an average age of 79 years, and 59% were female (Table 1). Approximately 60% of cohort 1 subjects in each dose group had been previously treated for AMD. The types of previous treatment were
Discussion
SAILOR is the largest study to date to evaluate safety (primary objective) and efficacy (secondary objective) of intravitreal ranibizumab in a population of subjects with CNV secondary to AMD. Ranibizumab was well tolerated, and the incidence of ocular SAEs and AEs was low and unrelated to dose. The rates of key nonocular SAEs and AEs, including APTC ATEs, MI, and vascular death, were similar across cohorts and dose groups.
The incidence of stroke in SAILOR was similar to that observed in
Acknowledgment
We thank Naveed Shams, MD, PhD, for contributions to the design and conduct of the study.
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Manuscript no. 2008-1521.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Genentech, Inc. (South San Francisco, California) provided support for the study and participated in study design; conducting the study; data collection, management, analysis, and interpretation; and manuscript preparation, review, and approval. David M. Boyer, consultant and lecturer for Genentech, Alcon, Pfizer, and Novartis. Jeffrey S. Heier, consultant and lecturer for Genentech, Regeneron, Jerini Ophthalmic, NeoVista, and ISTA; consultant for iScience, Pfizer, VisionCare, Allergan, Paloma, and Oxigene. David M. Brown, consultant and lecturer for Genentech, Alcon, and Regeneron; consultant for Novartis and Neovista. Steven F. Francom, employee of Genentech. Tsontcho Ianchulev, employee of Genentech. Roman G. Rubio, employee and equity owner, Genentech. Roberta Kelly, an employee and equity owner of Genentech, Inc., who is not an author and did not contribute to the scientific content of the manuscript, provided general writing and editorial assistance.