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M. J. Tolentino, LEVEL Study Group; Impact of Baseline Morphologic Factors, Visual Acuity (VA), and Induction on Treatment Response in the LEVEL Study. Invest. Ophthalmol. Vis. Sci. 2010;51(13):90.
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To analyze and explore the predictive impact of baseline factors such as retinal morphology and pre/postinduction visual acuity(VA) on treatment response in the LEVEL study an induction/maintenance regimen using Pegaptanib as the maintenance anti-VEGF agent for the treatment of exudative age related macular degeneration.
The LEVEL study is a multicenter, open-label study that enrolled subjects with all angiographic subtypes of subfoveal neovascular AMD (NV-AMD) from exudative age related macular degeneration . The study subjects required 1 to 3 induction treatments for NV-AMD 30-120 days pre-enrollment and must have had significant improvement of maculopathy. Pegaptanib was given every 6 weeks for 48 weeks. Patients were allowed booster therapy (other induction treatment besides pegaptanib) at investigators discretion. Visual acuity and optical coherence tomographs (OCTs) were obtained at regular intervals. Patients post induction OCTs were morphologically analyzed by masked readers. Morphologic analyses included integrity of the inner/outer segment (IS/OS) and the photoreceptor layer, presence of a foveal pit, subfoveal fibrovascular tissue (FVT) and intraretinal cysts or subretinal fluid. Morphologic analysis, mean pre/postinduction VA, type of induction therapy, and postinduction center point thickness (CPT) were correlated with mean change in VA over time.
The study enrolled 568 patients. Visual acuity was maintained over 48 weeks with pegaptanib sodium. Subjects with normal IS/OS and preserved photoreceptor layer, foveal pit presence, and absence of central FVT at baseline presented with better baseline and final VA. These morphological factors, CPT, post induction VA, or agent used for induction were not correlated with mean change in VA over time. Worst mean preinduction VA had a greater mean VA improvement (33 to 58 letters, 25 letter gain) than those with the best mean preinduction VA (67 to 73 letters, 6 letter gain).
Pegaptanib was able to maintain visual acuity gains over 48 weeks. While morphologic factors were correlated with post induction baseline visual acuity and final visual acuity, no baseline factors were correlated with overall treatment response of this induction maintenance regimen.
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