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 > or =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.
RCT Entities:
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 > or =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.
Authors: Laura Lorés-Motta; Moeen Riaz; Michelle Grunin; Jordi Corominas; Freekje van Asten; Marc Pauper; Mathieu Leenders; Andrea J Richardson; Philipp Muether; Angela J Cree; Helen L Griffiths; Connie Pham; Marie-Claude Belanger; Magda A Meester-Smoor; Manir Ali; Iris M Heid; Lars G Fritsche; Usha Chakravarthy; Richard Gale; Martin McKibbin; Chris F Inglehearn; Reinier O Schlingemann; Amer Omar; John Chen; Robert K Koenekoop; Sascha Fauser; Robyn H Guymer; Carel B Hoyng; Eiko K de Jong; Andrew J Lotery; Paul Mitchell; Anneke I den Hollander; Paul N Baird; Itay Chowers Journal: JAMA Ophthalmol Date: 2018-08-01 Impact factor: 7.389
Authors: Emily Y Chew; Traci E Clemons; Susan B Bressler; Michael J Elman; Ronald P Danis; Amitha Domalpally; Jeffrey S Heier; Judy E Kim; Richard Garfinkel Journal: Ophthalmology Date: 2013-11-08 Impact factor: 12.079
Authors: Abdhish R Bhavsar; Joseph M Googe; Cynthia R Stockdale; Neil M Bressler; Alexander J Brucker; Michael J Elman; Adam R Glassman Journal: Arch Ophthalmol Date: 2009-12