Real-World Study Suggests DME Patients Receive Suboptimal Anti-VEGF Dosing

Most patients with newly diagnosed treatment-naïve diabetic macular edema (DME) may be receiving suboptimal doses of anti-vascular endothelial growth factor (VEGF) injections, which results in suboptimal visual acuity (VA) gains in the real-world compared to clinical trial settings, according to new data from a large-scale, real-world retrospective cohort study presented at the 2018 annual meeting of the Association for Research in Vision and Ophthalmology (ARVO).

Jeffrey Willis MD

Jeffrey Willis, MD

To arrive at this finding, researchers led by Jeffrey Ryuta Willis, MD, PhD of Genentech gathered data from the American Academy of Ophthalmology’s Intelligent Research in Sight (IRIS) registry, the United States’ first electronic medical record-based eye disease registry. Of 197,220 patients in the registry, Willis and colleagues identified 13,410 cases of newly diagnosed, treatment-naïve DME.

Within 28 days of diagnosis, 9990 (74.5%) patients received no treatment, 2091 (15.6%) received anti-VEGF intravitreal injections, 113 (8.5%) received laser surgery, 130 (1%) received corticosteroids and 66 (0.5%) received combination treatment. Additionally, more than 28 days after diagnosis, the majority of patients who received no treatment continued to receive no treatment (8094; 81%). 1064, (10%) received delayed anti-VEGF, 708 (7.1%) received delayed laser surgery, 109 (1.9% received delayed corticosteroids and 15 (0.1%) received combination treatment.

Among patients who received anti-VEGF injections within the first 28 days following diagnosis, Willis and colleagues split the cohort into 3 groups based on their treatments thereafter: those who were observed (received no additional treatments), those that received 1-5 anti-VEGF injections, and those that received 6 or more anti-VEGF injections.

“Those that were observed started off with better visual acuity than the other 2 groups, and this visual acuity remained stable after 1 year. However, it’s important to note here that their visual acuity is not that great. It’s still 20/40 or worse on average,” Willis said during a presentation at the Hawaii Convention Center May 1. “When we looked at individuals who received 1 to 5 injections, their visual acuity gain was an improvement of 20/60 to 20/50, or about 3 letters. Individuals that received 6 or more anti-VEGF injections had a greater visual acuity gain. On average, they gained 0.1 logMAR units, so about a little over a line of letters.”

Patients who received anti-VEGF within the first 28 days of diagnosis had a mean number of injections after the 1-year follow-up of 4.2, while 49.8% received 3 injections or fewer during that period. The number of office visits during the first year was approximately 7.7, “about twice as often as they received anti-VEGF injections,” Willis said.

“The results from this database suggest that many patients with DME may not receive any treatment within a year following their initial diagnosis, with doctors potentially observing how a patient’s DME develops prior to treatment,” the authors noted. “These findings…are an important indicator of wider trends in the United States and will help guide future research and the development of new treatment strategies.”

Willis acknowledged several limitations of the study, including the fact that it only included data for one year, which limited the researchers’ insight into the longer-term management of DME. Additionally, many of the patients categorized as “observed” (not receiving treatment) could have been referred to ophthalmologists outside of the IRIS registry, leading to underestimation of treatment problems. Finally, selection bias could have occurred from practices where data is more stringent, and visual acuity rates were not available for all patients at follow-up.

“DME may be under treated in the real world,” Willis said. “Many patients may be getting suboptimally dosed and their visual acuity gains may be suboptimal compared to clinical trial settings.”

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