Thomas Ciulla: Real-World Outcomes for DME Patients


Thomas Ciulla speaks about the “real-world” outcomes for anti-VEGF therapy in patients with diabetic macular edema (DME) in the United States.

Thomas Ciulla, MD: We sought to look at real-world outcomes for DME with anti-VEGF, and the upshot is that patients in the real world being treated with the anti-VEGF for DME aren't doing as well as they are in trials. The reason for it is, in part under treatment, and in part ocular and systemic comorbidities. As we evolve from a volume-based fee-for-service health care system to a value-based system, physicians and the whole health care system are going to be accountable for their outcomes. We will be rewarded or penalized based on those outcomes, so these real-world studies become more and more important as we and our health care system evolve.

We found that on average, patients gain approximately 6 letters of vision at 1 year, and whether it was Avastin (bevacizumab), Lucentis (Ranibizumab) or Eylea (Aflibercept) used as an anti-VGEF agent, the results were all very similar. The other issue that we looked at was who's at risk most for vision loss, and what we found is that patients who start off with good vision, 20/40 or better, actually lose 2 letters of vision at 1 year. So they actually do poorly.

It turns out that patients are slightly under treated. Again, if we were to look at all these large, randomized clinical trials, patients get, on average, about 10 anti-VEGF injections in these trials depending which trial you look at. In the real world, retina specialists are administering approximately 8 injections on average in 1 year, so slight under treatment. Then, of course, the other reason for under performance in the real world is that these patients start off with other comorbidities, both ocular and systemic, that typically wouldn't be allowed in randomized clinical trials.

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