Artikel
Pegaptanib (Macugen) as a VEGF-binding agent for the treatment of choroidal neovascularization in AMD (EOP1009)
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Veröffentlicht: | 22. September 2004 |
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Purpose of the study is to determine the effect of intravitreal injections of pegaptanib sodium on foveal thickening in patients with subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD). Furthermore to evaluate the relationship between foveal thickening and visual acuity. In a phase II prospective, randomized, double-masked, sham controlled, dose-ranging, multicenter trial a total of 135 patients with subfoveal choroidal neovascularization in AMD will be enrolled. Patients will be randomized in 3 groups, receiving 0.3 mg, 1mg Pegaptanib or sham injection. Treatment will be administered every 6 weeks for 3 injections and patients will be followed without treatment through 24 weeks. At week 24 patients will resume treatment every 6 weeks for the period of 1 year. Group 1 and 2 (0.3mg/eye and 1mg/eye) will continue on the same dose, group 3 will be re-randomized at week 24 to 0.3mg/eye or 1 mg/ eye Pegaptanib for the remainder of the study. Efficacy outcome measures are foveal thickness measured with OCT and ETDRS visual acuity.