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Anti-VEGF treatments for diabetic macula oedema (DMO) reports Cochrane review meta-analysis.

Researchers at the Department of Neurosciences, Psychology, Drug Research and Child Health (NEUROFARBA), University of Florence, Italy and the Centre of Public Health, Queen’s University Belfast, UK, have published a Cochrane Library meta-analysis on several anti-VEFG (anti-vascular endothelial growth factor) treatments for diabetic macula oedema (DMO) patients.  The study found that all anti‐VEGF treatments improved vision (BVCA) with DMO, and “with no important differences in vision at two years between aflibercept (Eylea), bevacizumab (Avastin), brolucizumab (Beovu), and ranibizumab (Lucentis)”. The researchers reported “no clinically important differences in BCVA outcomes at 24 months, although there were differences in CRT (central retinal thickness) change”. In addition, their  paper commented that, “evidence from RCTs may not apply to real‐world practice, where people in need of antiangiogenic treatment are often under‐treated, and the individuals exposed to these drugs may be less healthy than trial participants”.

Diabetic retinopathy (DR) is the most frequent and severe ocular complication of diabetes, and according to the literature, an estimated one-third of people with diabetes have DR, and 1 in 10 is affected by DMO.  DMO is due to the breakdown of the blood-retina barrier with an increase in vascular permeability and treatment of anti-VEGF may reduce oedema.  In their current study, the objective of the updated review was to compare the effectiveness and safety of the different anti-VEGF drugs in RCTs (randomized control trials) at longer follow-up (24 months).

According to their results, 23 studies were assessed (including 13 with industry funding) comprising 3,513 patients with DMO.   The study design used ranibizumab (Lucentis) as the reference drug for efficacy, and the control (including laser, observation, and sham) as the reference for systemic safety.  Following the review, eight (8) trials provided data on the primary outcome of a change in BCVA at 24 months.  There was no evidence of a difference between the interventions and ranibizumab alone, showing: aflibercept (Eylea), with amean difference (mean difference, MD) −0.05 logMAR, 95% confidence interval (CI) −0.12 to 0.02); bevacizumab (Avastin) (MD ‐0.01 logMAR, 95% CI −0.13 to 0.10; brolucizumab (Beovu) (MD 0.00 logMAR, 95% CI −0.08 to 0.07; ranibizumab plus deferred laser (MD 0.00 logMAR, 95% CI −0.11 to 0.10; and ranibizumab plus prompt laser (MD 0.03 logMAR, 95% CI −0.04 to 0.09. These comparisons on efficacy show no clinical differences between them although there was moderate-certainty evidence of greater CRT reduction at 24 months with brolucizumab (MD −23 microns, 95% CI −65 to −1 9) and aflibercept (MD −26 microns, 95% CI −53 to 0.9) compared to ranibizumab.   The researchers stated that DMO causes “a significant burden of low vision and blindness, hence the importance of assessing and updating the evidence base for the effectiveness and safety of these agents”. In addition, the clinicians stated that, “there is a continuing clinical need to establish evidence-based recommendations regarding anti-VEGF agents. There is evidence that about two-thirds of people with DMO need treatment up to five years, although the number of injections may be low after year 2, and only 8% of participants received 20 or more injections in years 3 to 5”.