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M. S. Benz, Q. D. Nguyen, K. Chu, A. Cahn, I. Grimes, A. Ingerman, J. M. Cedarbaum; CLEAR-IT-2: Interim Results of the Phase II, Randomized, Controlled Dose-and Interval-Ranging Study of Repeated Intravitreal VEGF Trap Administration in Patients With Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2007;48(13):4549.
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To determine the safety, tolerability, and biological effect of repeated intravitreal (ITV) injection of VEGF Trap in patients with neovascular age-related macular degeneration (AMD).
Five groups of patients with neovascular AMD were randomized in a balanced ratio to receive a series of ITV injections of one of 3 dose levels of VEGF Trap (0.5, 2 or 4 mg) into the study eye at 4- or 12-week intervals over a 12-week period. Measures of bioactivity included changes from baseline in best-corrected ETDRS visual acuity (BCVA), foveal thickness, and macular volume determined by optical coherence tomography, as well as total lesion and CNV area determined by fluorescein angiography. Dosing was continued beyond week 12 using a criteria-based schedule.
The study is currently ongoing and treatment assignments remain masked. No ocular serious adverse events, no identifiable intraocular inflammation or serious drug-related systemic adverse events have been reported to date.
Repeated intravitreal VEGF Trap administration according to the dosing regimens employed in this study appears to be safe and well tolerated. Safety and bioeffect data will be updated at time of presentation.
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