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Adrian T. Fung, Nishant Kumar, Sushma Vance, Jason S. Slakter, James M. Klancnik, Jr., Richard S. Spaide, K. Bailey Freund; Pilot Study to EvaLuate the Role of High-dose RAnbizumab (2.0mg) in the Management of AMD in Patients with PerSistent/RecurrenT Macular Fluid Less than 30 days Following Treatment with Intravitreal Anti-VEGF Therapy (the LAST Study). Invest. Ophthalmol. Vis. Sci. 2012;53(14):2033.
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To compare monthly intravitreal ranibizumab 2.0 mg versus ranibizumab 0.5 mg in patients with neovascular age-related macular degeneration (AMD) and persistent or recurrent subretinal fluid (SRF) or intraretinal fluid (IRF) despite at least 6 consecutive monthly intravitreal anti-vascular endothelial growth factor injections.
A multi-center, single-masked, randomized, prospective, pilot study. Patients with subfoveal choroidal neovascularization secondary to AMD were enrolled. All study eyes had persistent SRF or IRF on spectral-domain optical coherence tomography (SD-OCT) less than 30 days following at least 6 monthly intravitreal injections of either ranibiuzumab or bevacizumab, and best-corrected visual acuity (BCVA) between 20/30 and 20/400 using an ETDRS chart. Patients were randomized 2:1 to receive either ranibizumab 2.0mg or ranibizumab 0.5mg. Each patient received three loading treatments of their assigned dose 4 weeks apart. After the first three injections, both groups were treated using a "treat and extend" regimen guided by eye-tracked SD-OCT through month 24. The primary endpoint was the mean change in BCVA using ETDRS letters at month 6. Secondary endpoints included change in sub-retinal pigment epithelial, SRF and IRF on SD-OCT, change in area of leakage on fluorescein angiography, mean number of treatments in both groups and any adverse events.
Nine eyes of 9 patients (mean age±SD, 82.0±5.8 years [range, 72-88]) were enrolled. Seven received ranibizumab 2.0mg and 2 received ranibizumab 0.5mg. At month 6, the mean improvement in BCVA was +6.3±3.7 ETDRS letters and +2.1±14.1 ETDRS letters in the 2.0mg and 0.5mg groups, respectively.
This pilot study demonstrates that high-dose ranibizumab (2.0mg) has the potential to maintain or improve BCVA in some patients with persistent or recurrent SRF or IRF secondary to neovascular AMD despite prior monthly intravitreal anti-VEGF therapy.
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