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B. M. Wirostko, S. N. Shah, G. Zlateva, Macugen Retrospective Study Group; Macugen Monotherapy in Newly Diagnosed Neovascular Age-Related Macular Degeneration (AMD). Invest. Ophthalmol. Vis. Sci. 2007;48(13):4580.
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To study the clinical effectiveness and safety of intravitreal pegaptanib sodium (Macugen®) monotherapy in subjects with newly diagnosed neovascular AMD in community-based practices.
Retrospective medical chart review of subjects with previously untreated subfoveal choroidal neovascularization secondary to AMD treated in private practices in the US. Subjects enrolled should have received Macugen monotherapy for a minimum of 4 treatments over a 24-week period in the study eye, with initial therapy on or after April 1, 2005. Other key inclusion criteria are best-corrected visual acuity (VA) of 20/40 - 20/200 in the study eye when Macugen was initiated and absence of other ocular pathologies that could impair visual acuity. Subjects should also have all pertinent study data appropriately documented in the medical chart. All data will be collected and analyzed by an independent clinical research organization after written informed consent is obtained from each individual subject. Primary endpoint is the mean change in VA from baseline to month 6. Secondary endpoints include the proportion of subjects gaining ≥3 lines of VA and losing less than 3 lines of VA, and ocular safety data.
To date there are 50 subjects enrolled from 4 sites. Subjects with all subtypes of neovascular AMD were included. Final assessment at month 6 will be compared to historical data from the pivotal trials on Macugen (V.I.S.I.O.N. study).
Treatment of neovascular AMD earlier in the course of the disease may provide better clinical benefits.
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