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    Ranibizumab proves effective for DMO in NHS clinics

    Patients treated for diabetic macular oedema with ranibizumab in the UK National Health Service (NHS) are getting benefits similar to those seen in clinical trials, a new study suggests.

    Treated on a pro re nata (as needed) basis, the patients gained a mean of 6.6 ETDRS letters in 12 months in the study, reported Ranjan Rajendram and colleagues at Moorfields Eye Hospital in London, UK. They published their findings in the American Journal of Ophthalmology.

    "This Moorfields study on a cohort of 200 eyes shows that results from landmark clinical trials are reproducible in clinical practice to a large extent," they wrote.

    Related: Aflibercept DME superiority diminishes in second year

    Although anti-vascular endothelial growth factor (VEGF) treatments have achieved impressive results in clinical trials, researchers have wondered whether the same effects can be achieved in a real-world setting where patients are less carefully chosen and don't have as much support in getting to appointments.

    To see how well the treatment is working in the NHS, Dr Rajendram and colleagues retrospectively analysed records on 200 eyes in 164 patients.

    The patients had a mean age of 65.11 years, and 63.4% were women. 36% were white, 28.7% were southeast Asian, 9.2% were Afro-Caribbean, and the rest were designated as "other" or "unknown."

    98% of the patients had type 2 diabetes and 2% had type 1 diabetes.

    Their mean baseline visual acuity was 54.5 letters. Their mean baseline central sub field thickness was 490.16 μm. Their mean baseline macular volume was 10.46 mm3.

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    The patients received treatment according to the European Union summary of product characteristics label for ranibizumab. The initial loading phase of injections consisted of three consecutive monthly intravitreal injections of 0.5 mg ranibizumab, followed by injections as needed.

    Re-treatment was not based on strict criteria, but in general treatment was withheld when there was no further improvement in visual acuity attributable to ranibizumab treatment and/or the macular fluid was stable on two consecutive visits. Patients were monitored every 2 months, and ranibizumab treatment was resumed if disease activity was observed until visual acuity and macular fluid were judged stable.

    Over the course of 12 months, the patients received a mean of 7.2 injections.

    The visual acuity benefit in these patients was similar to that in the RESTORE clinical trial, where patients gained 6.8 letters. It was superior to the 4.8 letter gain seen in the RELIGHT study, but less than the 9 letters in the Protocol I letter (which included prompt or deferred laser arms).

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