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J. Z. Li, A. M. Pleil, J. Loftus, C. S. Tressler, K. Kwok, A. F. Cruess, PERSPECTIVES Study Group; Changes of Vision Functioning and Related Quality of Life (QoL) in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Treated With Macugen for Up to 2 Years. Invest. Ophthalmol. Vis. Sci. 2010;51(13):88.
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Objective: To assess the efficacy of Macugen 0.3 mg in preserving vision function and QoL in subjects with NV-AMD.
In a Phase 3b/4, open-label, multicenter clinical trial (NCT00327470), 285 subjects with NV-AMD (107 with early + 178 with established lesions) from Canada and 14 European countries received in the study eye intravitreal Macugen (pegaptanib sodium) 0.3 mg every 6 weeks for 48 weeks and then every 12 weeks until week 102; salvage with standard of care treatment was allowed. Early lesions were defined as occult with classic in <50% of the total lesion, no subfoveal retinal hemorrhage, lipid exudation, or retinal pigment epithelial detachment (RPED), and baseline visual acuity ≥54 ETDRS letters or equivalent. Established lesions were defined as classic or occult with classic in >50% or occult with classic in <50% but associated with either retinal hemorrhage, lipid exudation, or RPED. Patients completed the National Eye Institute Visual Function Questionnaire (NEI-VFQ-25) and the EuroQol Group’s EQ-5D self-report questionnaire (EQ-5D) at baseline, Weeks 54 and 102 via telephone interview by a call center. QoL endpoints included change scores from baseline at Weeks 54 and 102 of the VFQ’s composite score and 12 subscales and the EQ-5D index.
For both groups, mean changes in VFQ composite scores decreased <2 in Year 1, <3 in Year 2, and <5 in two years. Mean changes in EQ-5D index scores (0.00 and -0.01 in Year 1, -0.01 and -0.03 in Year 2, -0.04 and -0.04 in two years for early vs established) showed similar patterns. Mean changes in VFQ subscales showed stable general health and vision but worsening visual functioning for most subscales for both groups. The early lesion group had worsened Driving in Year 1 and Ocular Pain in Year 2, while the established lesion group had worsened Role Difficulties in Year 2.
Neovascular AMD patients treated with Macugen had relatively stable vision functioning and QoL during the two years of treatment, though the rate of deterioration accelerated in Year 2.
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