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Ranibizumab (Lucentis) in neovascular age-related macular degeneration: evidence from clinical trials
  1. P Mitchell1,
  2. J-F Korobelnik2,
  3. P Lanzetta3,
  4. F G Holz4,
  5. C Prünte5,
  6. U Schmidt-Erfurth5,
  7. Y Tano6,
  8. S Wolf7
  1. 1
    Department of Ophthalmology, University of Sydney, Sydney, Australia
  2. 2
    Department of Ophthalmology, Centre Hospitalier Universitaire de Bordeaux, Bordeaux, France
  3. 3
    Department of Ophthalmology, University of Udine, Udine, Italy
  4. 4
    Department of Ophthalmology, University of Bonn, Bonn, Germany
  5. 5
    Department of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria
  6. 6
    Department of Ophthalmology, Osaka University Medical School, Osaka, Japan
  7. 7
    Department of Ophthalmology, Inselspital, University of Bern, Bern, Switzerland
  1. Correspondence to Professor P Mitchell, Eye Clinic (B4A), Westmead Hospital, Hawkesbury Road, Westmead, NSW, 2145, Australia; paul_mitchell{at}wmi.usyd.edu.au

Abstract

Background: Neovascular age-related macular degeneration (AMD) has a poor prognosis if left untreated, frequently resulting in legal blindness. Ranibizumab 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, retreatment 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 retreatment 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.

https://doi.org/10.1136/bjo.2009.159160

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    Footnotes

    • Funding Medical writing assistance was provided under the direction of the authors and was funded unconditionally by Novartis Pharma AG, Basel, Switzerland.

    • Competing interests PM has received a consultancy fee from Novartis Pharma AG, Pfizer, Solvay and Allergan. He has also been paid lecture fees/honoraria by Novartis Pharma AG, Pfizer, Solvay and Allergan. J-FK has received a consultancy fee from Novartis Pharma AG, Bayer Schering, Alcon, Pfizer and Thea. PL has received a consultancy fee from NeoVista, Allergan, Novartis Pharma AG and QLT. He has also been paid lecture fees/honoraria by Allergan, Novartis Pharma AG, QLT and Optimedica. He has patents with and/or royalties from Iridex Co. FGH has received a consultancy fee from Alcon, Acucela, Bayer Schering and Novartis Pharma AG. He has also been paid lecture fees/honoraria by Alcon and Novartis Pharma AG. CP has received a consultancy fee and lecture fee/honoraria from Novartis Pharma AG. US-E has received a consultancy fee from Novartis Pharma AG, Alcon and Bayer Healthcare. She has also been paid lecture fees/honoraria by Novartis Pharma AG, Alcon, Bayer Healthcare and Carl Zeiss Meditec. YT has received a consultancy fee from Novartis Pharma AG, Alcon Japan, Bausch & Lomb Japan, Pfizer Japan and Santen. He has also been paid lecture fees/honoraria by Novartis Pharma AG, Alcon Japan, Pfizer Japan and Santen. SW has received a consultancy fee from Novartis Pharma AG. He has also been paid lecture fees/honoraria by Novartis Pharma AG, Pfizer and Allergan.

    • Provenance and Peer review Not commissioned; externally peer reviewed.