Real-world treatment of DME yields fewer gains than in trials

Issue: September 25, 2014

SAN DIEGO — Patients with diabetic macular edema receive fewer intravitreal anti-VEGF injections in clinical practice than in published clinical trials, with consequently less visual acuity improvement, according to a speaker here.

Perspective from Paul E. Tornambe, MD, FACS

Nancy M. Holekamp, MD, and colleagues looked at large national claims databases to determine real-world treatment of diabetic macular edema and found that patients receive two to three anti-VEGF injections in a 12-month period.

“This is far below the monthly dosing we saw in RIDE and RISE. It’s even less than the average nine injections people received in the BOLT study,” Holekamp said at the American Society of Retina Specialists annual meeting.

In a subsequent analysis of electronic medical record data from a large health system in Pennsylvania, Holekamp and colleagues found that 75% of patients received three or fewer injections for DME over 12 months. In the 94 eyes studied, mean change in visual acuity from baseline was a gain of four letters at 6 months and 1.9 to 3.7 letters at 12 months. In comparison, patients gained 11.4 letters and 10.5 letters in the RIDE and RISE studies, respectively.

“What we knew before is that patients who received two to three injections in a 12-month period of time were likely being undertreated. What this study shows for the first time is that patients are also experiencing less visual acuity improvement,” Holekamp said.

The injection paradigm will be difficult to change due to the large total office visit burden in this population, she said, adding that treatments with longer duration of action are needed to achieve better visual acuity outcomes with fewer injections.

Disclosure: Holekamp has received consulting fees or honoraria from Allergan.

Perspective

Paul E. Tornambe, MD, FACS

The data are alarming, but the devil is always in the details. Doctors get paid for doing procedures, unless they are capitated, so beyond good medical care, it is in their financial interest to inject eyes with DME. Patients who are losing vision are usually compliant, especially if they have insurance. Before we jump on doctors for not following clinical trial data because they do not believe the literature or before we jump on patients for being lazy and not following up, we should consider that there may be other reasons why fewer injections were given. Were three or fewer injections given because the patient changed doctors or insurance plans? Were they snowbirds and went out of plan during the winter? Did they lose their insurance? Were they treated with drugs that were not covered by their plan or did they have a large co-pay that they could not afford? Had they already received many injections the prior year? (The trials suggest that fewer injections are needed in the second and third year.) Did they have a steroid pellet or an intravitreal triamcinolone injection just before or during the injection period? Did they have a vitrectomy? Did their medical control change? Did they start dialysis or was their blood pressure and/or blood sugar better controlled? Did they have a stroke or die? Was vision worse because they had prior steroid injections and are now developing a cataract, or were they started on treatment too late, after the DME was present for 2 to 3 years, making improvement unlikely on the basis of irreversible damage? If they were undertreated and lost vision because of it, we should find out why.

Paul E. Tornambe, MD, FACS

Retina Consultants

San Diego, Calif.

Disclosures: Tornambe has no relevant financial disclosures.