TY - JOUR
T1 - How the comparison of Age-related Macular Degeneration Treatments Trial results will impact clinical care
AU - Davis, Janet
AU - Olsen, Timothy W.
AU - Stewart, Michael
AU - Sternberg, Paul
N1 - Funding Information:
Publication of this article was supported by an unrestricted departmental grant from Research to Prevent Blindness (New York, New York) at Bascom Palmer, Emory, and Vanderbilt, and National Eye Institute (Bethesda, Maryland) Core Grants for Vision Research ( P30 EY 006360 , P30 EY08126 ). Dr Stewart has served on an advisory board for Regeneron (paid to his employer, the Mayo clinic). All authors have completed and submitted the ICMJE Form for Disclosure of Potential Conflicts of Interest and none were reported. This manuscript was conceived, written, and edited with substantive contributions from all 4 authors (J.D., T.O., M.S., P.S.). Given the editorial perspective nature of this manuscript, there are no issues related to IRB approval; HIPAA compliance; Clinical Trials registration, number, and location; or Institutional Animal Care and Use Committee guidelines.
PY - 2011/10
Y1 - 2011/10
N2 - Purpose: To provide a perspective on the impact of the Comparison of Age-related Macular Degeneration Treatments Trial (CATT) on future clinical practices. Design: Interpretation of trial outcomes relative to clinical use of neovascular age-related macular degeneration (AMD) treatments, assessment of the influence of study design and execution on results, and review of unanalyzed safety data in the online supplement. Methods: Expert opinion. Results: The CATT study supports the selection of either ranibizumab or bevacizumab for treatment of AMD based on factors other than efficacy, such as cost, because monthly administration of bevacizumab was noninferior to the reference treatment of monthly ranibizumab in improving visual acuity at 1 year. Visual acuity results for bevacizumab as needed were inconclusive for noninferiority relative to monthly administration of either drug. The secondary outcome of decrease in thickness at the foveal center as measured by time-domain optical coherence tomography significantly favored the monthly ranibizumab group vs the bevacizumab-as-needed group but is more difficult to interpret as it did not correlate with visual acuity and is less appropriate for a noninferiority design. Bevacizumab groups had a statistically higher observed risk of serious adverse events; however, scrutiny of the online supplements shows similar numbers of cardiac and neurologic events in bevacizumab and ranibizumab users. Information regarding fellow eye treatment with anti-VEGF agents was not given. Conclusions: CATT provides the first level I evidence for bevacizumab in a large number of patients with neovascular AMD. The trial supports use of either drug as primary therapy and suggests that modification of monthly dosing regimens is feasible. A difference in cardiovascular safety between the 2 drugs was not apparent on inspection of the supplementary safety data.
AB - Purpose: To provide a perspective on the impact of the Comparison of Age-related Macular Degeneration Treatments Trial (CATT) on future clinical practices. Design: Interpretation of trial outcomes relative to clinical use of neovascular age-related macular degeneration (AMD) treatments, assessment of the influence of study design and execution on results, and review of unanalyzed safety data in the online supplement. Methods: Expert opinion. Results: The CATT study supports the selection of either ranibizumab or bevacizumab for treatment of AMD based on factors other than efficacy, such as cost, because monthly administration of bevacizumab was noninferior to the reference treatment of monthly ranibizumab in improving visual acuity at 1 year. Visual acuity results for bevacizumab as needed were inconclusive for noninferiority relative to monthly administration of either drug. The secondary outcome of decrease in thickness at the foveal center as measured by time-domain optical coherence tomography significantly favored the monthly ranibizumab group vs the bevacizumab-as-needed group but is more difficult to interpret as it did not correlate with visual acuity and is less appropriate for a noninferiority design. Bevacizumab groups had a statistically higher observed risk of serious adverse events; however, scrutiny of the online supplements shows similar numbers of cardiac and neurologic events in bevacizumab and ranibizumab users. Information regarding fellow eye treatment with anti-VEGF agents was not given. Conclusions: CATT provides the first level I evidence for bevacizumab in a large number of patients with neovascular AMD. The trial supports use of either drug as primary therapy and suggests that modification of monthly dosing regimens is feasible. A difference in cardiovascular safety between the 2 drugs was not apparent on inspection of the supplementary safety data.
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U2 - 10.1016/j.ajo.2011.07.004
DO - 10.1016/j.ajo.2011.07.004
M3 - Article
C2 - 21961847
AN - SCOPUS:80053328390
SN - 0002-9394
VL - 152
SP - 509
EP - 514
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
IS - 4
ER -