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Maria Maldonado, David Brown, Charles Wykoff, ; Intravitreal Aflibercept for Recalcitrant Neovascular AMD. Invest. Ophthalmol. Vis. Sci. 2013;54(15):3800.
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Many eyes have recalcitrant age-related macular degeneration (AMD) with persistent activity despite monthly intravitreal 0.5 mg ranibizumab (RZB). The SAVE study demonstrated that these eyes improve anatomically and visually with a 2.0 mg/0.5 ml formulation of RZB (Opthalmology 2012, PMID:23131717). As this experimental RZB formulation is no longer available, this study was designed to test whether commercially available 2.0 mg aflibercept could maintain the gains and/or improve anatomical and visual acuity outcomes in this well characterized cohort.
In this Phase IV controlled clinical trial, fourty-five patients with recalcitrant neovascular AMD were treated with three mandatory monthly loading doses of 2.0 mg aflibercept followed by q8 week 2.0 mg aflibercept with PRN aflibercept given in the intervening months. Re-treatment was based on SD-OCT, clinical exam, and Early Treatment of Diabetic Retinopathy Study (ETDRS) four-meter refractions. To be included in the study, all patients must have received past 0.5 mg monthly RZB injections and subsequent 2.0 mg RZB injections through the SAVE trial.
Forty-five patients were enrolled in the study. Patients had on average 18.6 prior injections of 0.5 mg RZB and 21.5 injections of 2.0 mg RZB (through the SAVE trial) prior to enrollment. Mean refracted VA was 73.9 ETDRS letters at baseline and mean central subfield was 343μ. Anatomically, mean OCT central subfield thickness improvement from baseline was: -32.3μ at day 7, -24.8μ at month one, and -29.8μ at month two. Mean visual acuity gain (ETDRS) over baseline was +0.59 letters at day 7, -0.04 letters at month 1, and +0.42 letters at month 2. For those patients who continued on through month 6, the mean central OCT improvement from baseline was -44.5μ at month 3, -33.9μ at month 4, -43.5μ at month 5, and -32.8μ at month 6. Visual acuity gains were +0.9 letters at month 3, 0.0 letters at month 4, +0.3 letters at month 5, and +0.8 letters at month 6. No serious adverse events, including ocular adverse events, have been observed in any subject.
2.0 mg aflibercept intravitreal injections led to anatomic improvements even in patients with persistent fluid on a regimen of 2.0 mg RZB. Visual acuity gains achieved with 2.0 mg RZB were overall maintained on the commercially available dose of aflibercept.
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