Title: Brolucizumab for treating diabetic macular oedema [ID3902]
Funder: Department of Health and Social Care

Abstract: Diabetic macular oedema (DMO) is a common complication associated with diabetic retinopathy, and is the most common cause of visual impairment in diabetes mellitus. It occurs as a result of changes in retinal blood vessels in people with diabetes. Disruption of the blood–retinal barrier allows fluid to leak from blood vessels in the central part of the retina (the macula), leading to fluid accumulation and thickening of the macula. This can lead to severe visual impairment in the affected eye._x000D_ _x000D_ DMO can be classed as focal, diffuse or ischaemic (although no universal definition has been agreed). The majority of vision loss occurs when DMO involves the centre of the macula. This is known as clinically significant macular oedema (CSMO), and is regarded as the threshold for treatment._x000D_ _x000D_ More than 3.3 million people were diagnosed with diabetes in England in 2019[1] , and the condition is more common in people of African-Caribbean and South Asian family origin than in those of European family origin. Approximately 7% of people with diabetes may have DMO in England, of whom 39% have CSMO[2] . The prevalence of DMO is related to the duration and severity of diabetes, and to numerous risk factors including age, pregnancy, smoking, hypertension, nephropathy, obesity and high cholesterol._x000D_ _x000D_ Good management of diabetes and other risk factors may delay the onset and progression of DMO. This includes diet and lifestyle modification, blood pressure control and pharmacological treatments. NICE technology appraisals TA274 and TA346 recommend ranibizumab and aflibercept as options for treating visual impairment due to DMO if the eye has a central retinal thickness (CRT) of 400 micrometres or more at the start of treatment. For eyes with a CRT of less than 400 micrometres, laser photocoagulation may be a treatment option. In addition, bevacizumab is used outside its marketing authorisation in some NHS centres._x000D_ _x000D_ NICE technology appraisal TA301 recommends fluocinolone acetonide intravitreal implant as an option for treating chronic DMO that is insufficiently responsive to available therapies (laser photocoagulation and therapies targeting the vascular endothelial growth factor [VEGF]) if the implant is to be used in an eye with an intraocular (pseudophakic) lens. For DMO that does not respond to non corticosteroid treatment, or when such treatment is unsuitable, TA349 recommends dexamethasone intravitreal implant if the implant is to be used in an eye with an intraocular lens._x000D_ _x000D_ References_x000D_ 1 Diabetes UK (2020) Diabetes prevalence 2019. Accessed January 2022._x000D_ 2 Minassian DC, Owens DR, Reidy A. Prevalence of diabetic macular oedema and related health and social care resource use in England. British Journal of Ophthalmology 2012;96:345-349.

Lay abstract: To appraise the clinical and cost effectiveness of brolucizumab within its marketing authorisation for treating diabetic macular oedema.

Research activity codes: 6.1 PHARMACEUTICALS
Health categories: METABOLIC AND ENDOCRINE