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M. M. Altaweel, V.I.S.I.O.N. Study Group; Effects of Intravitreal Injection of Pegaptanib on the Retinal Pigment Epithelium and Optic Nerve. Invest. Ophthalmol. Vis. Sci. 2007;48(13):3369.
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To compare the effect of intravitreal injections of 0.3 mg pegaptanib sodium (Macugen®) and sham injections on retinal pigment epithelium (RPE) integrity and the optic nerve in subjects in the V.I.S.I.O.N trials with particular attention to the development of geographic atrophy (GA) and disc cupping.
Retrospective analyses of data from 2 randomized controlled trials Subjects with neovascular AMD received pegaptanib or sham injections for 48 weeks. In year 2, pegaptanib subjects were re-randomized to either continue or discontinue the same treatment. Subjects receiving sham in year 1 were re-randomized to receive pegaptanib, to continue sham, or to discontinue treatment. Color stereoscopic fundus photographs at baseline and week 102 were graded in a masked fashion by the University of Wisconsin reading center for geographic atrophy, RPE abnormality (area, location, severity), and potential glaucomatous changes. Results were compared for subjects receiving pegaptanib during both year 1 and 2 versus subjects receiving sham in year 1 and no pegaptanib in year 2.
No subject in the 0.3-mg pegaptanib group (n=107) and only one in the sham group (n=92) had GA within the AREDS grid at baseline. No subject in either group experienced progression of GA at week 102. Within the grid, worsening of maximum severity of RPE abnormality at week 102 was seen in 44.6% of sham and in 50.5% of the pegaptanib group; beyond the grid, progression of RPE abnormality occurred in 10.9% and 7.5% of these groups, respectively. Similarly, there was no significant difference between groups in the global severity of RPE damage compared to baseline as assessed by the proportions of subjects showing more damage within the grid (77% vs 67%, sham vs. pegaptanib groups) or beyond the grid (11% vs 8%, sham vs. pegaptanib groups). One definitive and 2 questionable cases of disc hemorrhage were reported in the pegaptanib group and none in the sham group. There was no evidence of disc notching or increasing cup disc ratio in either group.
Compared with sham, pegaptanib injections did not have a deleterious impact on the RPE or optic nerve in the V.I.S.I.O.N. trials as assessed by color stereoscopic fundus photographs.
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