2011-17: The Most Effective Treatment Strategy for Diabetic Macular Edema.
Diabetes mellitus is a worldwide epidemic with an anticipated prevalence of 4.4% in 2030. Diabetic macular edema (DME) often leads to severe visual acuity loss. It is expected that in 2025 there will be about 250.000 patients with DME in the Netherlands, with an annual incidence of 12.500 cases. Because of evident visual gain, current clinical treatment standards have switched from primary laser photocoagulation to (bi)monthly intravitreal anti-VEGF injections. It is conjectured that the outcome of photo¬coagulation therapy combined with intravitreal anti-VEGF injections is at least equivalent in visual outcome and, at the same time, helps to reduce the number of required intravitreal injections. With that, patient burden may become less and the growing demand on health care resources can be alleviated.
The objective of this study is to demonstrate that combined (repeated) laser photocoagulation prolongs time to failure compared to anti-VEGF monotherapy. This is a randomized, three-arms, double blind, comparative clinical trial with the primary endpoint being proportion of failures to treatment at 72 weeks.