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D.B. Roth, J.L. Prenner, S.N. Green, D.L. Yarian, S.R. Leff, E.S. Friedman, B.J. Keyser, H.M. Wheatley; Early Clinical Experience with Pegaptanib Sodium (Macugen) in Age–Related Macular Degeneration . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2149.
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To compare the early clinical experience and results of a sub–specialty community based practice to those obtained in the pivotal randomized prospective trials – the V.I.S.I.O.N. trials – in the treatment of exudative age–related macular degeneration (AMD) with intravitreal pegaptanib.
A retrospective chart review of a consecutive series of 50 eyes of 50 patients with exudative AMD was performed. Data analyzed including visual acuity of the treated eye, fellow eye status, lesion type as characterized by fluorescein angiography, presence of blood, ancillary testing with OCT, and previous interventions employed. Data was collected at the time of injection, at six weeks (second injection) and at three months. All patients received at least two injections, and were followed for at least 90 days.
Ninety–six percent of eyes had minimally classic or occult lesions, while four percent had predominantly or pure classic lesions. Sixty–eight percent of eyes had received previous therapy, while 32% of eyes were naïve to intervention. Fifty–eight percent of eyes were greater than four disk areas in size, and 20% had a significant amount of blood present. At three months, 88% of eyes had stabilized or improved visual acuity (8% gainers).
In this practice–based experience, the results of the V.I.S.I.O.N. trials were met, and were even surpassed. Eyes treated with intravitreal pegaptanib responded well, with results that were superior to those reported in the pivotal clinical trials. As compared to those trials, patients in this cohort responded favorably despite significant hurdles, e.g., that the vast majority of eyes had failed a previous therapy. This practical data supports the value of evidence based medicine, confirms that results of a large multi–centered randomized clinical trial can be replicated in one’s own practice, when adherence to the regimen of the trial is followed, and supports the use of intravitreal pegaptanib in clinical treatment of AMD.
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