Original articleFive-Year Outcomes with Anti–Vascular Endothelial Growth Factor Treatment of Neovascular Age-Related Macular Degeneration: The Comparison of Age-Related Macular Degeneration Treatments Trials
Section snippets
Design of the Comparison of Age-Related Macular Degeneration Treatments Trials Clinical Trial
The design and methods for the clinical trial have been published; therefore, only the key features with bearing on this study are provided.6, 7, 25, 26 Patients enrolled in CATT between February 20, 2008, and December 9, 2009. Eligible eyes (1 study eye per patient) had active choroidal neovascularization secondary to AMD; no previous treatment; VA between 20/25 and 20/320; and neovascularization, fluid, or hemorrhage under the foveal center. Patients were assigned randomly to 1 of 4 treatment
Patients
Among the 1117 patients alive at the end of the clinical trial (end of year 2), 203 (18.2%) died before the end of the CATT Follow-up Study. Of the remaining 914 patients, a VA measurement was available for 647 (70.8%) patients in the required interval of 51 months (4.3 years) to 85 months (7.1 years) after assignment of treatment in the clinical trial. The mean interval between enrollment in the clinical trial and the CATT Follow-up Study visit was 66.5 months (5.5 years; standard deviation
Discussion
The randomized clinical trials that established the efficacy of ranibizumab, bevacizumab, and aflibercept demonstrated that anti-VEGF therapy for neovascular AMD improved VA on average by 1 to 2 lines through 2 years.1, 2, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17 The CATT Follow-up Study provides long-term follow-up (mean, 5.5 years) of 70.8% of survivors. Mean VA declined to 3 letters worse than at baseline and 11 letters worse than at 2 years. This decrease in vision was accompanied by
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*Supplemental material is available at www.aaojournal.org.
Financial Disclosure(s): The author(s) have made the following disclosure(s): M.G.M.: Financial support – Roche/Genentech; Data Safety and Monitoring Committee – Genentech
G.Y.: Consultant – Janssen R & D; Chengdu Kanghong Biotech Co.
G.J.J.: Consultant – Alcon/Novartis; Neurotech; Roche/Genentech
C.A.T.: Financial support – Genentech, Inc; Royalties – Alcon, Inc; Thrombogenics; Nonfinancial support: Bioptigen; Patent − Duke University
Supported by the National Eye Institute, National Institutes of Health, Bethesda, Maryland (cooperative agreement nos.: U10 EY017823, U10 EY017825, U10 EY017826, and U10 EY017828). The funding organization participated in the design and conduct of the study, data analysis and interpretation, and review of the manuscript.
Author Contributions:
Conception and design: Maguire, Martin, Ying, Jaffe, Daniel, Toth, Grunwald, Fine
Analysis and interpretation: Maguire, Martin, Ying, Jaffe, Daniel, Toth, Grunwald, Ferris, Fine
Data collection: Maguire, Martin, Ying, Jaffe, Daniel, Toth, Grunwald, Ferris, Fine
Obtained funding: Maguire, Martin
Overall responsibility: Maguire, Martin, Ying, Jaffe, Daniel, Toth, Grunwald, Ferris, Fine
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The members of the Comparison of Age-Related Macular Degeneration Treatments Trials (CATT) Research Group are listed in the Appendix (available at www.aaojournal.org).