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Br J Ophthalmol doi:10.1136/bjo.2009.159160

Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials

  1. Paul R Mitchell (paul_mitchell{at}wmi.usyd.edu.au),
  2. Jean-François Korobelnik (jean-francois.korobelnik{at}chu-bordeaux.fr),
  3. Paolo Lanzetta (paolo.lanzetta{at}uniud.it),
  4. Frank G Holz (frank.holz{at}ukb.uni-bonn.de),
  5. Christian Pruente (christian.pruente{at}meduniwien.ac.at),
  6. Ursula Margarethe Schmidt-Erfurth (ursula.schmidt-erfurth{at}meduniwien.ac.at),
  7. Yasuo Tano (ytano{at}ophthal.med.osaka-u.ac.jp),
  8. Sebastian Wolf (sebastian.wolf{at}insel.ch)
  1. University of Sydney, Australia
  2. CHU (Centre Hospitalier Universitaire) de Bordeaux, France
  3. University of Udine, Italy
  4. University of Bonn, Germany
  5. Medical University of Vienna, Austria
  6. AKH 8i, Medizinische Universität Wien, Austria
  7. Osaka University Medical School, Japan
  8. Universitaetsklinik fuer Augenheilkunde, Switzerland
    • Published Online First 13 May 2009

    Abstract

    Background: Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab (Lucentis®; Novartis Pharma AG, Basel, Switzerland; Genentech Inc., South San Francisco, CA, USA) is approved for treating neovascular AMD. However, further guidance is needed to assist ophthalmologists in clinical practice to optimise treatment outcomes.

    Methods: An international retina expert panel assessed evidence available from prospective, multicentre studies evaluating different ranibizumab treatment schedules (ANCHOR, MARINA, PIER, SAILOR, SUSTAIN, and EXCITE) and a literature search to generate evidence based and consensus recommendations for treatment indication and assessment, re-treatment, and monitoring.

    Results: Ranibizumab is indicated for choroidal neovascular lesions with active disease, the clinical parameters of which are outlined. Treatment initiation with three consecutive monthly injections, followed by continued monthly injections, has provided the best visual-acuity outcomes in pivotal clinical trials. If continued monthly injections are not feasible after initiation, a flexible strategy appears viable, with monthly monitoring of lesion activity recommended. Initiation regimens of fewer than three injections have not been assessed. Continuous careful monitoring with flexible re-treatment may help avoid vision loss recurring. Standardised biomarkers need to be determined.

    Conclusion: Evidence-based guidelines will help to optimise treatment outcomes with ranibizumab in neovascular AMD.

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    3. All Versions of this Article:
      1. bjo.2009.159160v1
      2. bjo.2009.159160v2
      3. bjo.2009.159160v3
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