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D. M. Marcus, VEGF Inhibition Study in Ocular NeovascularizationClinical Trial Group; Four-Year Safety of Pegaptanib Sodium in Neovascular Age-Related Macular Degeneration (AMD): Results of the V.I.S.I.O.N. Trial. Invest. Ophthalmol. Vis. Sci. 2008;49(13):5069.
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To evaluate the safety of pegaptanib treatment in neovascular AMD in the V.I.S.I.O.N. trial.
Two concurrent, multicenter, double-masked studies included patients with all angiographic subtypes of NV-AMD. At week 156, those receiving 0.3 or 1 mg pegaptanib continuously over the prior 3 years could continue therapy for a further 18 injections over 108 weeks for a total study period of 5 years (264 weeks).
In year 4, 60 subjects received 395 pegaptanib injections (mean=6.6). As in previous years, adverse events were mostly ocular, mild, and predictable. Two cases of endophthalmitis (0.51%/injection; both related to injection protocol deviations), 1 each of traumatic cataract, retinal hemorrhage, and chorioretinal atrophy (0.25%/injection for each), and 0 cases of retinal detachment (0%/injection) were reported. In comparison, cumulative incidence of endophthalmitis across 11 studies and 25,373 injections was 0.11%/injection. Among the 60 subjects after 4 years of continuous pegaptanib, there was no evidence of increased intraocular pressure, unexpected retinal-vessel abnormalities, notable delays in arterio-venous transit time, abnormalities in choroidal perfusion, or arteriolar occlusions. In all 4 years among these 60 subjects, investigators reported 2 deaths (pulmonary embolism; motor-vehicle accident; 1.7%/patient for each) and 3 serious cardiac disorders (atrial fibrillation, cardiac arrest, myocardial infarction; 1.7%/patient for each); but no cerebro-vascular accidents, central nervous system hemorrhages, or transient ischemic attacks; and no gastrointestinal, genitourinary, or respiratory tract hemorrhages.
Although limited by the absence of a control group and the small number of subjects, year-4 V.I.S.I.O.N. safety data are consistent with previous reports and suggest no evidence of an increased risk of ocular or systemic adverse events associated with continuous selective intravitreal anti-VEGF therapy.
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