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J. S. Slakter, CLEAR-IT 2 Investigators; A Phase 2, Randomized, Controlled Dose-and Interval-Ranging Study of Intravitreal VEGF Trap-Eye in Patients With Neovascular Age-Related Macular Degeneration: Optical Coherence Tomography (OCT) and Fluorescein Angiography (FA) Outcomes at 1 Year. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1890.
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To present 1 year data on VEGF Trap-Eye, a fusion protein that penetrates all retinal layers binding with high affinity to all VEGF-A isoforms and placental growth factor, with special emphasis on anatomic outcomes as measured by optical coherence tomography (OCT) and fluorescein angiography (FA).
In this randomized, double masked, multi-center Phase 2 trial, patients with neovascular AMD received VEGF Trap-Eye 0.5 or 2.0 mg monthly or 0.5, 2.0, or 4.0 mg quarterly for 12 weeks, followed by PRN dosing to 1 year. Anatomic efficacy measures included changes from baseline in central retinal/lesion thickness (CR/LT), total macular volume (TMV), and pigment epithelial defect thickness (PED) as measured by OCT, and total lesion area and choroidal neovascularization (CNV) area as determined by FA. All OCT and FA images were assessed by central reading centers.
One year results for all groups combined (n=157) demonstrated significant decreases from baseline in CR/LT of -130µm (p< 0.0001), in TMV of -1.1 mm3 (p< 0.0001) and in PED thickness (n = 46 with PED at baseline) of -102µm. All groups combined at 1 year showed a modest decrease from baseline in total lesion size (mean change of -0.39 mm2), and significant reductions of active CNV size (mean change of -2.21 mm2, p< 0.0001) and classic CNV size (mean change of -1.21 mm2, p< 0.0001). Patients dosed with 2 mg monthly for 12 weeks followed by PRN dosing, in general, achieved the largest improvements in anatomic as well as visual acuity measures.
VEGF Trap-Eye produced significant reductions in CR/LT, TMV and PED thickness as well as significant reductions in CNV and classic CNV size at 1 year compared to baseline.
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