ADA: Intravitreal aflibercept injection shows consistency of effect across levels of HbA1c control in diabetic macular edema

Patients with diabetic macular edema (DME) treated with aflibercept injection significantly improved vision and reduced the severity of diabetic retinopathy versus laser photocoagulation, according to data recently presented at the American Diabetes Association (ADA) Scientific Sessions in San Francisco.

In a new exploratory within-group analysis of the phase 3 VISTA VIVID DME studies, measures of visual acuity and central retinal thickness change were evaluated by baseline quartile HbA_1c levels. Findings suggest consistency of effect with aflibercept compared to laser.  

The VIVID and VISTA trials are similarly designed, randomized, double-masked, active control trials to evaluate the safety and efficacy of aflibercept in 872 patients with DME.  Patients in both trials were randomly assigned to receive either aflibercept 2 mg monthly, aflibercept 2 mg every 2 months (after 5 initial monthly injections), or the comparator treatment of laser photocoagulation. The primary efficacy end point was the mean change in best-corrected visual acuity (BCVA) from baseline at week 52.

In the VISTA VIVID DME studies, aflibercept was shown to significantly improve vision vs. laser photocoagulation in patients with DME with every-other-month administration following 5 initial monthly doses as well as with monthly dosing. Aflibercept has been on the market since 2011 to treat 2 other eye conditions.  

“The most interesting finding was that patients who had the best HbA_1c control actually did better with focal laser than those who had poor control,” said David Brown, MD, Retina Consultants of Houston, who presented the data. “While these gains were modest compared with the [aflibercept] groups, the patients with the best control gained, on average, 4 letters with laser compared with no average gain in the quartile with the worst glycemic control.” 

About 1.5 million people are currently diagnosed with DME and approximately another million more may be undiagnosed. DME is a frequent manifestation of diabetic retinopathy (DR), the most common diabetic eye disease.

“While anti-VEGF medications are rapidly becoming the standard of care for DME, the results of this sub-group analysis imply that focal laser may be theoretically helpful in patients with the best glycemic control,” said Dr Brown. “Thus, if a managed care group is able to improve glycemic control in its overall population, it could potentially see cost savings if patients’ macular edema can be controlled by laser and thus delay anti-VEGF therapy.

DME is the most frequent cause of vision loss in patients with diabetes and eventually can lead to blindness.  According to the CDC,  more than 29 million American adults currently living with diabetes, thus many individuals are at risk for developing DME and potentially losing some or all of their site.

“Exploring new treatments for DME is a crucial component of diabetes management,” Dr Brown said. “Although controlling the underlying systemic disease is the primary goal in diabetes care, the results of this analysis from the VIVID and VISTA trials are encouraging and suggest the consistency of effect with [ compared to laser in patients with varying levels of baseline HbA_1c.”

Dr Brown is a consultant for Regeneron and Genentech.