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P.J. Rosenfeld, A.E. Fung, G.A. Lalwani, S. Michels, A.S. Venkatraman, C.A. Puliafito; Visual Acuity Outcomes Following a Variable–Dosing Regimen for Ranibizumab (LucentisTM) in Neovascular AMD: The PrONTO Study . Invest. Ophthalmol. Vis. Sci. 2006;47(13):2958.
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Ranibizumab (LucentisTM, Genentech) was shown to improve the average visual acuity (VA) of eyes with neovascular AMD given an intravitreal injection every month for at least 1 year in the Phase III clinical trials. These VA results were similar to the earlier Phase I/II study results. In the ongoing Phase I/II extension study at the Bascom Palmer Eye Institute, we have maintained the improved VA for at least 2 years using a less frequent variable dosing regimen. To test this variable dosing regimen, we have 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 macular neovascularization with an OCT central thickness 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 by OCT, new onset classic neovascularization, or new macular hemorrhage.
Forty patients were enrolled and followed for at least 7 months. By Month 3, 1 month after the last scheduled injection, the mean VA score improved by 10 letters (p<0.001) and the mean central thickness measurement decreased by 190µm (p<0.001). By Month 7, 5 months after the last scheduled injection, the average number of retreatments per eye was 0.2 with 50% of eyes receiving no additional treatment. The mean VA improved by 9 letters (p<0.001) and the mean central thickness measurement decreased by 158 microns (p<0.001) compared with baseline. No drug–related adverse events were observed.
The improvements in VA and OCT measurements observed by Month 3 were maintained through Month 7 using a variable dosing regimen. Continued follow–up is planned for 2 years.
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