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G. A. Lalwani, A. E. Fung, S. Michels, S. R. Dubovy, W. J. Feuer, Jr., C. A. Puliafito, P. J. Rosenfeld; An OCT-Guided Variable-Dosing Regimen With Ranibizumab (Lucentis) in Neovascular AMD: Two Year Results of the PrONTO Study. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1834.
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To investigate an OCT-guided variable dosing regimen using intravitreal Lucentis (Ranibizumab, Genentech) for the treatment of neovascular age-related macular degeneration (AMD), we initiated a single-site, FDA-reviewed, investigator sponsored trial known as the Prospective OCT Imaging of Patients with Neovascular AMD Treated with Intra-Ocular Lucentis (PrONTO) Study.
Neovascular AMD patients with VA from 20/40 to 20/400 and OCT central retinal thickness measurements of at least 300 µm were enrolled. Each patient received 3 consecutive monthly injections of ranibizumab (500µg) in their study eye given at baseline, Month 1, and Month 2. OCT measurements were obtained at baseline and on post-injection days 1, 2, 4, 7, 14, and 30 during the first 2 months then monthly thereafter. EDTRS visual acuities were obtained at baseline and on post-injection days 14, 30, 45, 60 and then monthly thereafter. Fluorescein angiography was performed at baseline and every 3 months. Retreatment with ranibizumab was performed only if one of the following occurred: an increase in central OCT thickness of at least 100 µm, a loss of 5 letters in conjunction with recurrent fluid detected by OCT, new onset classic neovascularization, or new macular hemorrhage.
Forty patients were enrolled. By year 1, the mean VA score improved by 9.3 letters (p<0.001) and 82.5% of patients experienced 0 or more letters gained compared with baseline. The average number of injections, including the injections at Month 12, was 5.6 with a median of 5.0 injections. No drug-related adverse events were observed. The study in on-going through 2 years and these 2 year results will be available in April 2007.
The improvements in VA and OCT outcomes observed at 3 months were sustained through 12 months using this variable-dosing regimen. Two year results will be presented.
www.clinicaltrials.gov #NCT00344227 12345
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