Abstract
ObjectivesThis paper describes recommendations from a panel of UK retina experts on aflibercept in diabetic macular oedema (DMO).MethodsA roundtable meeting was held in London, UK in March 2018. The meeting was sponsored by Bayer.ResultsRecommendations are based on clinical experience and level 1 evidence. Clinical experience supports the evidence base, reinforcing that aflibercept should be initiated with intensive proactive dosing at 2 mg every 4 weeks. Most panel members use six initial 4-weekly doses as in Protocol T, rather than five initial monthly doses as recommended in the Summary of product characteristics (SmPC). After intensive proactive dosing, patients with a good response (meet Protocol T ‘improvement’ criteria ≥5-letter improvement in visual acuity [VA] and/or ≥10% improvement in central subfield thickness [CST] from baseline) but who are not yet stable should continue with 4-weekly aflibercept until stability is reached. Patients with a good response and stability should initiate monitor-and-extend (not in line with SmPC). Those with a sub-optimal response (meet ‘improvement’ criteria but with additional concerns e.g. fluid worsening on macular volume map) should continue with 4-weekly aflibercept but additional treatments should be considered (aflibercept is not licensed for combination treatment). For patients with no response (no change, or meeting Protocol T ‘worsening’ criteria [≥5-letter decrease in VA and/or ≥ 10% increase in CST] from baseline), switching to a non-anti-vascular endothelial growth factor treatment should be considered.ConclusionsClinical experience reinforces that, when using aflibercept in DMO, the licensed posology or Protocol T regimens achieve the best outcomes.
Highlights
Bradford, UK 5 Southampton General Hospital, Southampton, UK 6 Aberdeen Royal Hospitals National Health Service (NHS) Trust, Aberdeen, UK 7 Medical Affairs, Bayer Plc, Reading, UK 8 The Royal Wolverhampton NHS Trust, Wolverhampton, UKDiabetic macular oedema (DMO) is characterised by accumulation of fluid from leaking blood vessels [1], caused by breakdown of the blood-retinal barrier [2]
Aflibercept is approved for the treatment of visual impairment due to diabetic macular oedema (DMO); the licensed posology is shown in Table 1 and Appendix Fig. 1 [4]
At the 24-week visit, response to aflibercept treatment should be assessed in order to determine continued management (Fig. 1)
Summary
Diabetic macular oedema (DMO) is characterised by accumulation of fluid from leaking blood vessels [1], caused by breakdown of the blood-retinal barrier [2]. DMO is often associated with exudates and can lead to blurring and distortion of central vision [2]. It represents the most common cause of visual impairment in patients with diabetes, accounting for around 75% of cases of vision loss [3]. Aflibercept is approved for the treatment of visual impairment due to DMO; the licensed posology is shown in Table 1 and Appendix Fig. 1 [4]. Based on the results from the Protocol T trial [5, 6], guidelines from the European Society of Retina Specialists (EURETINA), published in
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