Enhanced efficacy associated with early treatment of neovascular age-related macular degeneration with pegaptanib sodium: an exploratory analysis

PURPOSE: To assess the vision benefit of treating early subfoveal choroidal neovascularization secondary to age-related macular degeneration (AMD) with pegaptanib sodium. METHODS: Exploratory analyses of week 54 vision outcomes (VEGF Inhibition Study in Ocular Neovascularization study) of subject subgroups with early disease who received 0.3 mg of pegaptanib (Groups 1 [n = 34] and 2 [n = 30]) or sham injections (usual care). Two sets of clinical characteristics typical of early disease defined the subgroups. RESULTS: Baseline characteristics were generally well balanced between treatment arms. Pegaptanib responder rates (loss of <15 letters of visual acuity) were 76% and 80% in treatment Groups 1 and 2 versus 50% and 57% for usual care Groups 1 and 2 (P = 0.03 and P = 0.05), respectively. Compared with subjects assigned to pegaptanib, those in Groups 1 and 2 receiving usual care on average lost 11.1 letters and 12.7 letters more of visual acuity (P < 0.01 and P < 0.006), respectively. Subjects assigned to usual care were approximately 10 times more likely to have severe vision loss than were those treated with pegaptanib (Group 1, 29% vs. 3%, respectively; P < 0.01). In Group 1, 12% of pegaptanib-treated subjects gained > or =15 letters of visual acuity versus 4% receiving usual care; 20% of Group 2 pegaptanib-treated subjects gained > or =15 letters of visual acuity versus none of the usual care subjects. CONCLUSION: Early detection and treatment with pegaptanib may result in superior vision outcomes in patients with neovascular AMD.