Original articleSeven-Year Outcomes in Ranibizumab-Treated Patients in ANCHOR, MARINA, and HORIZON: A Multicenter Cohort Study (SEVEN-UP)
Section snippets
Study Design
The SEVEN-UP study (ClinicalTrials.gov identifier, NCT01256827) is a multicenter, cross-sectional study of the long-term outcomes of a cohort of patients originally treated with ranibizumab within the ANCHOR and MARINA trials and subsequently enrolled and treated with ranibizumab in the HORIZON study. The study was conducted in accordance with the Health Insurance Portability and Accountability Act and the tenets of the Declaration of Helsinki and with approval of respective institutional
Study Population and Baseline Characteristics
The study cohort was defined as the total 357 subjects who initially were treated with ranibizumab for 24 months in the MARINA or ANCHOR trial and who then also completed 24 months in the ranibizumab arm of the HORIZON study. Of this cohort, 155 subjects were eligible from the 14 sites participating in the SEVEN-UP study, 65 of whom were enrolled in the current study (42% enrollment). Study design, eligibility, and enrollment are shown in Figure 1 (available at http://aaojournal.org). Reasons
Discussion
In this cross-sectional cohort study, 65 patients with exudative AMD were recalled for evaluation at 7 to 8 years after they had been enrolled in the ANCHOR or MARINA trials. This group had received 2 years of monthly ranibizumab treatment, followed by an additional 2 years of as-needed ranibizumab treatment in the HORIZON protocol. This cohort provides an opportunity to study the longest period of ranibizumab therapy with the greatest duration of follow-up for this chronic disease. The
Acknowledgments
The authors thank Travis Porco, PhD, UCSF Proctor Foundation, for statistical consulting, and Suzanne Staveley, Envision Scientific Solutions, for graphics assistance.
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A full listing of the SEVEN-UP Study Group is available in Appendix 1 at http://aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Robert B. Bhisitkul - Consultant - Genentech, Santen, Pfizer; Financial support - Genentech, GlaxoSmithKline
David S. Boyer - Consultant - Alcon, Allergan, Genentech, Regeneron, Neurotech, Novartis/QLT, Pfizer, and iCo; Financial support - Alcon, Allergan, Genentech, and Regeneron SriniVas R. Sadda - Consultant - Genentech, Allergan, Heidelberg Engineering; Financial support - Genentech, Carl Zeiss Meditec, Optovue; Patents - Topcon Medical Systems Kang Zhang - Consultant - Genentech, Acucela; Financial support – Genentech.
Supported by Genentech, Inc., South San Francisco, California; Research to Prevent Blindness, Inc., New York, New York; the National Eye Institute, National Institutes of Health, Bethesda, Maryland (core grant no.: EY002162); and the That Man May See Foundation, San Francisco, CA.
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Group members listed online in Appendix 1 (available at http://aaojournal.org).