May 2007
Volume 48, Issue 13
Free
ARVO Annual Meeting Abstract  |   May 2007
An OCT-Guided Variable-Dosing Regimen With Ranibizumab (Lucentis) in Neovascular AMD: Two Year Results of the PrONTO Study
G. A. Lalwani; A. E. Fung; S. Michels; S. R. Dubovy; W. J. Feuer, Jr.; C. A. Puliafito; P. J. Rosenfeld
Author Affiliations & Notes
  • G. A. Lalwani
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Mia, Florida
  • A. E. Fung
    Ophthalmology, Pacific Eye Associates, California Pacific Medical Center, San Francisco, Florida
  • S. Michels
    Ophthalmology, University of Vienna, Vienna, Austria
  • S. R. Dubovy
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Mia, Florida
  • W. J. Feuer, Jr.
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Mia, Florida
  • C. A. Puliafito
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Mia, Florida
  • P. J. Rosenfeld
    Ophthalmology, Bascom Palmer Eye Institute, University of Miami Miller School of Medicine, Mia, Florida
  • Footnotes
    Commercial Relationships G.A. Lalwani, None; A.E. Fung, Genentech, Inc., F; Genentech, Inc., Santen, Inc., C; Genentech, Inc., Santen, Inc., R; S. Michels, Novartis, R; S.R. Dubovy, None; W.J. Feuer, None; C.A. Puliafito, Zeiss Meditec, F; Zeiss Meditec, P; Genentech, Inc., R; P.J. Rosenfeld, Genentech, Eyetech, Alcon, F; Genentech, Eyetech Pharmaceuticals, Novartis Ophthalmics, Allergan, Protein Design Labs, Tanox, Genaera, Jerini AG, Athenagen, Quark, C; Genentech, Eyetech, Novartis Ophthalmics, Zeiss Meditec, R.
  • Footnotes
    Support Genentech, Inc., and an unrestricted grant from Research to Prevent Blindness, Inc., New York, NY
Investigative Ophthalmology & Visual Science May 2007, Vol.48, 1834. doi:
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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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Abstract

Purpose:: 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.

Methods:: 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.

Results:: 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.

Conclusions:: 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.

Clinical Trial:: www.clinicaltrials.gov #NCT00344227 12345

Keywords: age-related macular degeneration • choroid: neovascularization • imaging methods (CT, FA, ICG, MRI, OCT, RTA, SLO, ultrasound) 
© 2007, The Association for Research in Vision and Ophthalmology, Inc., all rights reserved. Permission to republish any abstract or part of an abstract in any form must be obtained in writing from the ARVO Office prior to publication.
Copyright © 2024 Association for Research in Vision and Ophthalmology.
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