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  • Title: Super-dose anti-VEGF (SAVE) trial: 2.0 mg intravitreal ranibizumab for recalcitrant neovascular macular degeneration-primary end point.
    Author: Brown DM, Chen E, Mariani A, Major JC, SAVE Study Group.
    Journal: Ophthalmology; 2013 Feb; 120(2):349-54. PubMed ID: 23131717.
    Abstract:
    PURPOSE: To determine whether a higher dose of intravitreal ranibizumab could improve the anatomy and best-corrected visual acuity (BCVA) in eyes with neovascular age-related macular degeneration (AMD) with persistent disease activity despite monthly intravitreal anti-vascular endothelial growth factor (VEGF) injections. DESIGN: Phase I to II multicenter, open-label, controlled clinical trial. PARTICIPANTS: Eighty-seven patients with recalcitrant neovascular AMD, defined as having leakage on fundus fluorescein angiography or spectral domain optical coherence tomography (SD-OCT) despite monthly anti-VEGF injections. METHODS: Patients were treated with 2.0-mg ranibizumab injections monthly for 3 doses and monitored with Early Treatment Diabetic Retinopathy Study (ETDRS) 4-m refractions, clinical examinations, and SD-OCT. MAIN OUTCOME MEASURES: The mean change in baseline visual acuity (VA), the percentage of patients who experienced a loss or gain of 15 or more letters in ETDRS BCVA, the mean change in central retinal thickness, and the incidence of adverse events. RESULTS: Eighty-seven patients with an average of 24 injections before enrollment and a mean of 10.4 injections in the preceding 12 months had a mean refracted VA of 69.2 ETDRS letters (20/41 Snellen) and a mean central subfield of 422 μm at baseline. Mean VA gain over baseline was +2.5 letters at day 7 (n = 82), +3.7 letters at month 1 (n = 87), +3.9 letters at month 2 (n = 87), and +3.3 letters at month 3 (20/36 Snellen; P = 0.001; n = 86). Anatomic outcomes showed a mean optical coherence tomography central subfield thickness improvement from baseline of -48.4 μm at day 7 (n = 84), -37.5 μm at month 1 (n = 87), -42.4 μm at month 2 (n = 85), and -33.1 μm at month 3 (P = 0.01; n = 86). CONCLUSIONS: Intravitreal injections of 2.0 mg ranibizumab led to statistically significant VA gains and anatomic improvement in patients with persistent intraretinal, subretinal, or subretinal pigment epithelial fluid during a previous regimen of chronic monthly 0.5-mg ranibizumab injections.
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