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An Optical Coherence Tomography-Guided, Variable Dosing Regimen with Intravitreal Ranibizumab (Lucentis) for Neovascular Age-related Macular Degeneration

Published:February 15, 2007DOI:https://doi.org/10.1016/j.ajo.2007.01.028

      Purpose

      To evaluate an optical coherence tomography (OCT)-guided, variable-dosing regimen with intravitreal ranibizumab for the treatment of patients with neovascular age-related macular degeneration (AMD).

      Design

      Open-label, prospective, single-center, nonrandomized, investigator-sponsored clinical study.

      Methods

      In this two-year study, neovascular AMD patients with subfoveal choroidal neovascularization (CNV) (n = 40) and a central retinal thickness of at least 300 μm as measured by OCT were enrolled to receive three consecutive monthly intravitreal injections of ranibizumab (0.5 mg). Thereafter, retreatment with ranibizumab was performed if one of the following changes was observed between visits: a loss of five letters in conjunction with fluid in the macula as detected by OCT, an increase in OCT central retinal thickness of at least 100 μm, new-onset classic CNV, new macular hemorrhage, or persistent macular fluid detected by OCT at least one month after the previous injection of ranibizumab.

      Results

      At month 12, the mean visual acuity improved by 9.3 letters (P < .001) and the mean OCT central retinal thickness decreased by 178 μm (P < .001). Visual acuity improved 15 or more letters in 35% of patients. These visual acuity and OCT outcomes were achieved with an average of 5.6 injections over 12 months. After a fluid-free macula was achieved, the mean injection-free interval was 4.5 months before another reinjection was necessary.

      Conclusion

      This OCT-guided, variable-dosing regimen with ranibizumab resulted in visual acuity outcomes similar to the Phase III clinical studies, but required fewer intravitreal injections. OCT appears useful for determining when retreatment with ranibizumab is necessary.
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      References

        • Gragoudas E.S.
        • Adamis A.P.
        • Cunningham Jr, E.T.
        • et al.
        VEGF Inhibition Study in Ocular Neovascularization Clinical Trial Group.
        N Engl J Med. 2004; 351: 2805-2816
        • Rosenfeld P.J.
        • Brown D.M.
        • Heier J.S.
        • et al.
        Ranibizumab for neovascular age-related macular degeneration.
        N Engl J Med. 2006; 355: 1419-1431
        • Brown D.M.
        • Kaiser P.K.
        • Michels M.
        • et al.
        Ranibizumab vs verteporfin for neovascular age-related macular degeneration.
        N Engl J Med. 2006; 355: 1432-1444
      1. Preliminary results from a phase IIIb study showed patients with wet AMD treated with Lucentis quarterly experienced a 16-letter benefit over the control group at one year. [press release]. South San Francisco, California: Genentech; June 2, 2006. Available at: http://www.gene.com/gene/news/press-releases/display.do?method=detail&id=9747. Accessed Date: August 26, 2006.

        • Chen Y.
        • Wiesmann C.
        • Fuh G.
        • et al.
        Selection and analysis of an optimized anti-VEGF antibody: crystal structure of an affinity-matured Fab in complex with antigen.
        J Mol Biol. 1999; 293: 865-881
        • Heier J.S.
        • Antoszyk A.N.
        • Pavan P.R.
        • et al.
        Ranibizumab for treatment of neovascular age-related macular degeneration: a phase I/II multicenter, controlled, multidose study.
        Ophthalmology. 2006; 113 (e1–e4): 642
        • Rosenfeld P.J.
        • Heier J.S.
        • Hantsbarger G.
        • et al.
        Tolerability and efficacy of multiple escalating doses of ranibizumab (Lucentis) for neovascular age-related macular degeneration.
        Ophthalmology. 2006; 113 (e1): 632
        • Treatment of Age-Related Macular Degeneration with Photodynamic Therapy (TAP) Study Group
        Photodynamic therapy of subfoveal choroidal neovascularization in age-related macular degeneration with verteporfin: one-year results of 2 randomized clinical trials TAP report 1.
        Arch Ophthalmol. 1999; 117: 1329-1345

      Biography

      Anne E. Fung, MD, graduated with honors in Chinese Studies and Economics from Wellesley College in 1993 and received her MD from Cornell University Medical College in 1999. After completing residency at Stanford University, she pursued a research fellowship at the Smith Kettlewell Eye Research Institute. In 2005, she completed a Medical Retina fellowship at the Bascom Palmer Eye Institute and returned to San Francisco to join her father at Pacific Eye Associates/California Pacific Medical Center where she continues clinical research in age-related macular degeneration.

      Biography

      Geeta A. Lalwani, MD, is currently a surgical retina fellow at the Bascom Palmer Eye Institute in Miami, Florida. She received an AB from Smith College, and an MD from the MCP-Hahnemann School of Medicine, where she was elected into the Alpha Omega Alpha honor society. She will complete her fellowship in July 2007.

      Linked Article

      • Ranibizumab According to Need: A Treatment for Age-related Macular Degeneration
        American Journal of OphthalmologyVol. 143Issue 4
        • Preview
          Age-related macular degeneration (AMD) is increasing in incidence and prevalence among the world’s population. Inhibition of the vascular component of AMD has been attempted with a variety of approaches, but the development of the pan-vascular endothelial growth factor (VEGF)-A blocker, ranibizumab (Lucentis, Genentech, South San Francisco, California, USA), for the treatment of choroidal neovascularization (CNV) has been a triumph of modern medicine.1 Ranibizumab is an antibody fragment that binds all active isoforms of VEGF-A, rendering them inactive.
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