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M.S. Ip, M. Patel, M. Goldbaum, B. Katz, C. Beals, VEGF Inhibition Study in Ocular Neovascularization(V.I.S.I.O.N. ) Clinical Trial Group; Efficacy of Pegaptanib Sodium in Neovascular AMD by Angiographic Subtype Using Different Reading Centers . Invest. Ophthalmol. Vis. Sci. 2006;47(13):5237.
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© ARVO (1962-2015); The Authors (2016-present)
Assess potential bias of angiographic interpretation of entry fluorescein angiography (FA) by differing reading centers on outcomes of the V.I.S.I.O.N. trial
Retrospective analysis of 2 randomized studies in which neovascular AMD subjects received either pegaptanib sodium or sham injections for 48 weeks. At week 54, pegaptanib subjects were re–randomized to either continue or discontinue the same treatment for additional 48 weeks. Patients receiving sham in year 1 were re–randomized to receive pegaptanib, to continue sham, or to discontinue treatment. Subjects were classified at entry based on FA as having predominantly classic (PC), minimally classic (MC), or occult lesions (OC). Classification was provided by: a) investigators, b) independent reading center (Univ. of Wisconsin – Fundus Photography Reading Center [UW–FPRC]), and c) Eligibility and Classification Quality Assurance Team (ECQAT).
Concordance among all 3 readers was present in 61% (728/1188) of subjects. In 590 subjects receiving pegaptanib 0.3 mg or sham in year 1, there was discordance in FA interpretation between investigators and UW–FPRC (36% of cases), between investigators and ECQAT (22%), and between UW–FPRC and ECQAT (24%). When analyzing mean change in VA from baseline to week 54, the relative benefit of using pegaptanib 0.3 mg compared to sham, applying the investigators' interpretation, was 63%, 55%, and 35% for PC, MC and OC lesions respectively. The relative benefit of pegaptanib 0.3 mg, applying UW–FPRC data, was 31%, 62%, and 42% for PC, MC and OC lesions respectively. Employing ECQAT data, the relative benefit of pegaptanib 0.3 mg was 54%, 52%, and 43% for PC, MC and OC lesions, respectively. Results favoring pegaptanib were also seen regarding proportion of subjects gaining 2 and 3 lines and avoiding 6–line loss. A total of 133 subjects received pegaptanib 0.3 mg for 2 years and 107 subjects received sham in year 1 and sham or no therapy in year 2. The proportion of subjects losing <15 letters after 2 years was higher in the pegaptanib 0.3 mg group compared to sham across all subtypes and all readers.
Angiographic interpretation of neovascular AMD varies depending on the reader or reading center. In the V.I.S.I.O.N. trial, evidence of pegaptanib efficacy was seen across all of the dataset in all angiographic subgroups further validating the hypothesis that vascular endothelial growth factor is a common denominator in neovascular AMD irrespective of subtype classification.
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