TY - JOUR
T1 - Ranibizumab for Predominantly Classic Neovascular Age-related Macular Degeneration
T2 - Subgroup Analysis of First-year ANCHOR Results
AU - Kaiser, Peter K.
AU - Brown, David M.
AU - Zhang, Kang
AU - Hudson, Henry L.
AU - Holz, Frank G.
AU - Shapiro, Howard
AU - Schneider, Susan
AU - Acharya, Nisha R.
N1 - Funding Information:
This study was funded by Genentech, Inc, South San Francisco, California, and Novartis Pharma AG, Basel, Switzerland. Dr Kaiser has received honoraria from Genentech, Allergan, Alcon, Novartis, Occulogix, Regeneron, Quark, QLT, and TargeGen, and his institution (Cole Eye Institute, Cleveland, Ohio) has received grant support from Genentech, Allergan, Alcon, Novartis, QLT, and Regeneron. Dr Brown has received consulting fees from Genentech, Eyetech/Pfizer, Novartis, and Alcon, is a stockholder in Pfizer, has received lecture fees from Genentech and Eyetech/Pfizer, and grant support from Genentech, Alcon, Allergan, Acuity, and Eyetech/Pfizer. Dr Zhang has received grant support from Genentech. Dr Hudson has received consulting fees from Genentech and lecture fees from Alcon. Dr Holz has received consulting fees from Genentech, Bayer, Sirion Therapeutics, Pfizer Ophthalmics, Novartis, Alcon, Zeiss Meditech, and Heidelberg Engineering, and grant support from Novartis. Drs Schneider and Shapiro are Genentech employees, and Dr. Schneider is a stockholder. Dr Acharya was a research fellow at Genentech. Involved in conception and design of study (P.K.K., D.B., H.H., S.S., N.A.); analysis and interpretation of data (P.K.K., D.B., K.Z., F.H., H.S., S.S., N.A.); writing of article (P.K.K., H.S., S.S., N.A.); critical revision of the article (P.K., D.B., H.H., H.S., S.S., N.A.); final approval of article (P.K.K., D.B., K.Z., H.H., F.H., H.S., S.S., N.A.); provision of materials, patients, or resources (P.K.K., D.B., K.Z., H.H.); statistical expertise (H.S.); literature search (N.A.). Institutional Review Board, National Competent Authority, or Ethics Committee approval of the study protocol was obtained at each participating clinical center prior to the start of the study. All United States study sites were compliant with the Health Insurance Portability and Accountability Act of 1996. This study is registered at ClinicalTrials.gov (ID No. NCT00061594 ). Prior to determination of their full eligibility for enrollment, all patients provided written, informed consent for their study participation. The list of the ANCHOR Study Group is available at AJO.com .
Funding Information:
Nisha R. Acharya, MD, MS, is Director of Ocular Inflammatory Disease and Uveitis Clinic at University California, San Francisco (UCSF) Proctor Foundation. Her education/training includes: undergraduate/master’s at Stanford University; MD at UCSF; internship at Brigham & Women’s Hospital; ophthalmology residency at Massachusetts Eye and Ear Infirmary; Cornea, External Disease and Uveitis fellowship at Proctor Foundation; and research fellowship at Genentech. She has a K23 Career Development Award from the National Eye Institute.
Copyright:
Copyright 2018 Elsevier B.V., All rights reserved.
PY - 2007/12
Y1 - 2007/12
N2 - Purpose: Subgroup data from a pivotal phase 3 study comparing ranibizumab (LUCENTIS) with verteporfin (VISUDYNE) photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) were retrospectively analyzed to identify patient and disease characteristics that may predict visual acuity (VA) treatment outcomes. Design: Retrospective subgroup analysis of 12-month data from the ANCHOR study. Methods: Univariate analyses were performed to assess VA outcomes across subgroups based on patients' gender and baseline age, VA score, CNV lesion size, CNV lesion type, and duration of neovascular AMD, followed by multivariate analyses to identify predictors of the VA score change from baseline at 12 months. main outcome measures: Proportion of patients losing <15 letters and proportion gaining ≥15 letters from baseline VA; mean change from baseline VA. Results: On average, all subgroups of ranibizumab-treated patients did better than PDT patients for all three VA outcome measures. In the multivariate analysis, lower baseline VA score, smaller baseline CNV lesion size, and younger baseline age were associated with greater gain of letters with ranibizumab treatment and less loss of letters with PDT. Conclusions: Subgroup analysis of 12-month data from the ANCHOR study showed ranibizumab to be superior to PDT in all subgroups evaluated, and was consistent with the subgroup analysis of 24-month data from the other pivotal phase 3 study of ranibizumab (MARINA) in showing that the most important predictors of VA outcomes were, in decreasing order of impact, the patient's baseline VA score, CNV lesion size, and age.
AB - Purpose: Subgroup data from a pivotal phase 3 study comparing ranibizumab (LUCENTIS) with verteporfin (VISUDYNE) photodynamic therapy (PDT) in patients with predominantly classic choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) were retrospectively analyzed to identify patient and disease characteristics that may predict visual acuity (VA) treatment outcomes. Design: Retrospective subgroup analysis of 12-month data from the ANCHOR study. Methods: Univariate analyses were performed to assess VA outcomes across subgroups based on patients' gender and baseline age, VA score, CNV lesion size, CNV lesion type, and duration of neovascular AMD, followed by multivariate analyses to identify predictors of the VA score change from baseline at 12 months. main outcome measures: Proportion of patients losing <15 letters and proportion gaining ≥15 letters from baseline VA; mean change from baseline VA. Results: On average, all subgroups of ranibizumab-treated patients did better than PDT patients for all three VA outcome measures. In the multivariate analysis, lower baseline VA score, smaller baseline CNV lesion size, and younger baseline age were associated with greater gain of letters with ranibizumab treatment and less loss of letters with PDT. Conclusions: Subgroup analysis of 12-month data from the ANCHOR study showed ranibizumab to be superior to PDT in all subgroups evaluated, and was consistent with the subgroup analysis of 24-month data from the other pivotal phase 3 study of ranibizumab (MARINA) in showing that the most important predictors of VA outcomes were, in decreasing order of impact, the patient's baseline VA score, CNV lesion size, and age.
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U2 - 10.1016/j.ajo.2007.08.012
DO - 10.1016/j.ajo.2007.08.012
M3 - Article
C2 - 17949673
AN - SCOPUS:36249002808
VL - 144
SP - 850-857.e4
JO - American Journal of Ophthalmology
JF - American Journal of Ophthalmology
SN - 0002-9394
IS - 6
ER -