Background and research question: Diabetic macular oedema (DME) is the leading cause of vision loss in the working age population in developed countries. Therapeutic approaches so far have been laser photocoagulation (current gold standard), intravitreal steroid injections and vitrectomy. In this report we address the question whether vascular-endothelial-growth-factor-inhibitors (anti-VEGF), leads to better clinical outcomes and fewer adverse events than current treatments in patients with clinically manifest diabetic macular oedema.
Methods: We performed a systematic literature search in common medical and HTA-databases and synthesised the evidence according to the GRADE-methodology.
Results: Overall quality of evidence for efficacy of anti-VEGF in the management of DME is moderate, while quality of evidence for safety is very low. In a proportion of patients (on average 25%) VEGF-inhibitors result in better visual acuity (≥ 15 ETDRS letters or equivalent) than in patients treated with with laser photocoagulation or sham-injection. However, the number of injections required for long-term improvement as well as general long-term efficacy is unknown. While neither study demonstrated serious safety problems, evidence is not sufficient to regard the products as safe in patients with DME. Concerning the different products, there is slightly stronger evidence supporting ranibizumab compared to bevacizumab, however due to the lack of head-to-head trials, this does not suggest superiority of a single product.
Conclusion: For some patients with DME, VEGF-inhibitors seem to be a more effective short-term treatment than alternative therapies. Evidence is not of sufficient quality to confirm safety. Decision on financing should take into account the high price-difference between the products and the fact that many studies are still ongoing.