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M. B. Ulinska, J. P. Szaflik, R. Buggage, PERSPECTIVES Study Group; Pegaptanib Efficacy Results in Multicenter, Open-label Study (Phase 3b/4) of Early CNV in Neovascular AMD Over Time, Including Vision Function and QOL EndpointS: The PERSPECTIVES Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4575.
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To describe PERSEPCTIVES study, a 102 week open-label multicenter trial in 18 countries enrolling subjects with neovascular AMD.
The PERSPECTIVES Study was designed to assess the efficacy and safety of Macugen 0.3 mg for the preservation of vision and quality of life (QoL) in subjects with early and established CNV neovascular AMD lesions. Subject stratum assignment as early CNV or established CNV lesions is determined by the investigator based upon baseline ophthalmic examination including fundus photos, fluorescein and indocyanine green angiography. Study eyes receive Macugen 0.3 mg every 6 weeks for 48 weeks and then every 12 weeks through week 102. Visual function assessments including distance (ETDRS) and near (modified Bailey-Lovie) visual acuity, reading speed and contrast sensitivity are tested at multiple timepoints and patient reported QoL questionnaires (NEI-VFQ and EuroQoL) performed in the subject’s language are collected at baseline and weeks 54 and 102.
370 subjects (185/stratum) are being recruited in the study providing 95% confidence intervals (CIs) for the primary efficacy endpoint, the mean change in best-corrected distance visual acuity from baseline to week 54 in subjects with early and established CNV lesions. Secondary endpoints including mean changes in distance VA from baseline to week 102 and mean changes in near visual acuity, reading speed, contrast sensitivity and QoL scores from baseline to weeks 54 and 102 will also be summarized for the early and established CNV lesion groups.
Although clinical evidence suggests that treatment of early stage neovascular AMD lesions can improve visual acuity outcomes, a more comprehensive assessment of visual function, patient perception of treatment benefit and QoL gains may yield a more complete framework for determining the value of neovascular AMD treatments. The PERSPECTIVES study was designed to evaluate this more complete framework of assessments in subjects with early stage relative to more advanced stage neovascular AMD lesions receiving treatment with Macugen 0.3 mg over 2 years in clinical practice.
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