Original articleVerteporfin plus Ranibizumab for Choroidal Neovascularization in Age-Related Macular Degeneration: Twelve-Month Results of the DENALI Study
Section snippets
Study Design and Objectives
The DENALI study was a randomized, double-masked, active-controlled, multicenter, phase IIIb clinical trial assessing the efficacy and safety of verteporfin PDT administered in conjunction with ranibizumab versus ranibizumab monotherapy for the treatment of subfoveal CNV secondary to AMD. The study was conducted according to the ethical principles of the Declaration of Helsinki and was approved by the appropriate ethics committees. All study participants provided written informed consent.
The
Study Population
A total of 321 patients were randomized to receive verteporfin SF combination therapy (n = 104), verteporfin RF combination therapy (n = 105), or ranibizumab monotherapy (n = 112). Overall, the baseline demographics across the 3 groups were well balanced. Mean baseline BCVA scores were comparable (53.8, 54.6, and 54.5 letters in the verteporfin SF plus ranibizumab, verteporfin RF plus ranibizumab, and the ranibizumab monotherapy groups, respectively). Ocular characteristics were comparable
Discussion
Because of their different methods of action, the combination of ranibizumab with verteporfin PDT has a theoretical potential to reduce the frequency and cost of neovascular AMD treatment while maintaining the VA improvements observed with ranibizumab monotherapy. The SUMMIT clinical trials program is the first large-scale clinical investigation to address this combination.
In this trial, ranibizumab was administered initially as 3 consecutive monthly injections (and then PRN) in both the
Acknowledgments
The authors thank Ruthline Laylor, Chameleon Communications International, for providing medical writing services with funding from Novartis Pharma AG, and Ruchika Srinivasan, Medical Communications, Novartis Healthcare Pvt. Ltd., for the revisions (based on author input) and resubmission of this article.
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2018, Photodiagnosis and Photodynamic TherapyCitation Excerpt :After an independent review, 52 articles were excluded for several reasons. Finally, 8 RCTs were included [25–32]. The reference search process and exclusion reasons are summarized in Fig. 1.
Manuscript no. 2011-638.
Supported by Novartis Pharma AG, Basel, Switzerland. This study is registered with Clinicaltrials.gov (NCT00436553). The sponsor participated in the design of the study, data management, data analysis, and review of the manuscript.
Financial Disclosure(s): The author(s) have made the following disclosure(s):
Peter K. Kaiser - Consultant - Novartis Pharma AG, Genentech, Inc.
David S. Boyer - Consultant - Novartis Pharma AG, Genentech, Inc., Alcon
Alan F. Cruess - Consultant - Novartis Pharma AG; Lecturer - Novartis Pharma AG, Alcon
Jason S. Slakter - Consultant - Novartis Pharma AG, Genentech, Inc., Regeneron
Stefan Pilz - Employee - Novartis Pharma AG
Annemarie Weisberger - Employee - Novartis Pharmaceuticals Corporation
At all stages the authors have had control over the content of this manuscript, for which they have given final approval and take full responsibility. Novartis Pharma AG enforces a no ghost-writing policy. As funding sponsors, they have had the opportunity to review the manuscript, but do not have authority to change any aspect of the manuscript.
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Appendix 1 (available at http://aaojournal.org) contains a list of the principal investigators who participated in this study.