Abstract
The current standard therapy for patients with diabetic macular oedema (DME)—focal/grid laser photocoagulation—usually does not improve impaired vision, and many patients lose vision despite laser therapy. Recent approval of ranibizumab by the European Medicines Agency to treat visual impairment due to DME fulfils the previously unmet medical need for a treatment that can improve visual acuity (VA) in these patients. We reviewed 1- and 2-year clinical trial findings for ranibizumab used as treatment for DME to formulate evidence-based treatment recommendations in the context of this new therapy. DME with or without visual impairment should be considered for treatment when it fulfils the Early Treatment Diabetic Retinopathy Study (ETDRS) criteria for clinically significant oedema. For DME with centre involvement and associated vision loss due to DME, monthly ranibizumab monotherapy with treatment interruption and re-initiation based on VA stability is recommended. Laser therapy based on ETDRS guidelines is recommended for other forms of clinically significant DME without centre involvement or when no vision loss has occurred, despite centre involvement. Because these recommendations are based on randomised controlled trials of 1–2 years duration, guidance may need updating as long-term ranibizumab data become available and as additional therapeutic agents are assessed in clinical trials.
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Acknowledgements
We would like to acknowledge Laura Saunderson of Chameleon Communications International, who provided medical writing services with funding from Novartis Pharma AG, Basel, Switzerland. This encompassed preparation of the first draft, referencing, preparing tables and figures, and incorporating authors’ revisions, all under the direction of the authors. At all stages, the authors have had full control over the content of this manuscript, for which they have given final approval and take full responsibility. Novartis Pharma AG enforces a ‘no ghost-writing’ policy. The expert panel meeting was sponsored by Novartis Pharma AG. As funding sponsors, they have had the opportunity to review the manuscript, but do not have authority to change any aspect of the manuscript. Funding for the expert panel meeting and medical writing services was provided by Novartis Pharma AG, Basel, Switzerland.
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FB is an advisory board member for Alcon, Allergan, Bausch & Lomb, Bayer, Novartis Pharma AG, Pfizer, and Thea. JC-V is a consultant for Novartis, Pfizer, Alcon, Bayer, Allergan, and Astellas Pharma Europe. NVC is a consultant for Novartis Pharma AG, Pfizer, Allergan, Merck, Bayer, and Iridex. GEL received consultancy fees and travel reimbursement from Novartis Pharma AG. PMa received consultancy fees from Novartis Pharma AG, Allergan, Fovea Pharmaceutical, Sanofi Aventis, and Takeda and has also been paid lecture fees by Novartis Pharma AG, Allergan, and Takeda. PMi received consultancy and lecture fees and travel reimbursements from Novartis Pharma AG, Pfizer, Allergan, Solvay (now Abbott), and Bayer. MP received consultancy fees and travel reimbursements from AstraZeneca, Novartis Pharma AG, Pfizer, Roche Diagnostics, and Takeda. CP received consultancy fees and travel reimbursement from Novartis Pharma AG. RS received consultancy fees and travel reimbursement from Novartis Pharma AG. US-E is a consultant for Alcon, Bayer, Novartis, and Pfizer. The University of Vienna performs contract research as a clinical trial centre and Central Reading Centre.
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Bandello, F., Cunha-Vaz, J., Chong, N. et al. New approaches for the treatment of diabetic macular oedema: recommendations by an expert panel. Eye 26, 485–493 (2012). https://doi.org/10.1038/eye.2011.337
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DOI: https://doi.org/10.1038/eye.2011.337
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