Original articleRanibizumab versus Bevacizumab to Treat Neovascular Age-related Macular Degeneration: One-Year Findings from the IVAN Randomized Trial
Section snippets
Study Design, Participants, and Setting
The IVAN is a multicenter, factorial, noninferiority, randomized trial with equal allocation to each of 4 groups formed by all permutations of 2 drugs and 2 treatment regimens. Allocation to drug was masked. Allocation to treatment regimen was not masked. Further details are described in the protocol (Appendix 2, available at http://aaojournal.org).
Adults ≥50 years old with previously untreated nAMD in the study eye and best corrected visual acuity ≥25 letters on the Early Treatment Diabetic
Participants and Treatment
Between March 27, 2008, and October 15, 2010, we randomized 628 participants; 18 were withdrawn before receiving the first treatment, leaving 610 who were treated and included in analyses (Fig 1). Participants' characteristics at baseline were similar across the groups (Table 1). Nine participants were ineligible. One read <25 letters; 8 failed the independent graded angiographic eligibility criteria, although 2 had fluid on OCT suggesting an active lesion.
Regarding adequacy of masking,
Discussion
One year after randomization in the IVAN trial, the visual acuity comparison by drug was inconclusive. The mean difference between the drugs was 2 letters in favor of ranibizumab, a small difference from a clinical perspective. The difference in visual acuity between continuous and discontinuous regimens was negligible, showing that the treatment regimens were equivalent.
There were no significant differences between drugs or regimens for secondary measures of visual function or generic quality
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Manuscript no. 2012-496.
The IVAN study investigators are listed online (available at http://aaojournal.org).
Financial Disclosure(s): The authors have made the following disclosures:
Usha Chakravarthy, Principal Investigator, trials sponsored by Novartis, the manufacturers of ranibizumab, and attendance at advisory boards for Allergan, Bausch & Lomb, and Bayer; Andrew J. Lotery, Principal Investigator, trials sponsored by Novartis, the manufacturers of ranibizumab; Honoraria, Novartis; Attended Advisory Board Meetings, Novartis, Bayer. Simon P. Harding, Principal Investigator, trials sponsored by Novartis, the manufacturers of ranibizumab; Susan M. Downes, Honoraria, Novartis.
The Queen's University of Belfast and the Belfast Trust, the University of Southampton, the University Hospital Southampton NHS Foundation Trust, and Oxford University Hospital have received payments from Novartis.
This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) program (project number 07/36/01). The trial was designed, conducted, analyzed, and interpreted independently of the funding sources. The writing committee had full access to the data and is responsible for submitting the publication. The views and opinions expressed are those of the authors and do not necessarily reflect those of the HTA programme, NIHR, the UK National Health Service or the Department of Health.
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Group members listed online in Appendix 1 (available at http://aaojournal.org).