EBM Focus articles provide concise summaries of clinical trials most likely to inform clinical practice curated by the DynaMed® editorial team.

Aflibercept is a vascular endothelial growth factor (VEGF) inhibitor first approved for treatment of diabetic macular edema (DME) in July 2014 after several large trials showed that it was superior to laser photocoagulation in patients with reduced visual acuity. It is an intravitreal injection administered every four weeks for five injections, and then every eight weeks for at least an additional 20 weeks. Before the introduction of VEGF-inhibitors, laser photocoagulation was the standard of care for treatment of DME with or without preserved visual acuity. In a randomized clinical trial, aflibercept was compared to either laser photocoagulation or observation to determine whether aflibercept has the same benefit in patients with DME and preserved visual acuity as in patients with reduced visual acuity.

The study included 702 adults with type 1 or type 2 diabetes, with only one study eye per participant. There were three treatment groups: laser photocoagulation, aflibercept injections, and observation. However, some patients in each group received aflibercept injections. Sixteen percent of patients in the aflibercept group had a decrease in visual acuity of one line or more at two years compared to 17 percent of patients receiving laser photocoagulation and 19 percent of those in the observation group. These were not statistically significant differences. At the end of the trial period, all three groups had a mean vision of 20/20 and the mean changes in visual acuity were not statistically significant. Aflibercept was associated with increased frequency of increased intraocular pressure compared to observation, while laser photocoagulation was not. The clinical significance of this is unclear.

Cost is a critical consideration when deciding among therapies with similar efficacy. Each aflibercept injection costs around $1,850, with total baseline treatment cost in the United States of about $416,250 compared to $120,000 for patients having laser photocoagulation. Additionally, 80 of the 236 eyes in the observation group received at least one aflibercept injection with a median of nine injections over two years ($16,650). The bottom line is that for diabetic patients with preserved visual acuity, the benefit of receiving aflibercept or photocoagulation, even in patients with DME, is limited. Given the cost associated with both aflibercept injections and laser photocoagulation, the benefits may not justify these invasive therapies. More data are needed to determine whether aflibercept makes a difference in the preservation of vision in patients with DME.

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