Allen Ho, MD, discusses the Protocol W outcomes and what they indicate for prescribing ophthalmologists.
New two-year results from the DRCR Retina Network Protocol W trial showed benefit of aflibercept treatment in the reduced risk of proliferative diabetic retinopathy (PDR) and center-involved diabetic macular edema (CI-DME) development at 2 years among patients with patients with non-proliferative DR (NPDR).
The findings, presented at the Association for Research in Vision and Ophthalmology (ARVO) 2021 Virtual Sessions this weekend, showed reduced change in patient visual acuity among those administered the anti-VEGF therapy versus sham treatment.
The National Institutes for Health (NIH)-funded trial, presented by Raj K. Maturi, MD, of the Midwest Eye Institute, observed 328 patients with moderate to severe NPDR in either or both eyes, randomly assigned either intravitreal 2 mg aflibercept or sham. Treatment was administered at baseline, 1, 2, and 4 months, then every 4 months through 2 years. In events where CI-DME with vision loss or high-risk PDR developed, patients were provided aflibercept.
In an ARVO 2021 interview with HCPLive® regarding the study findings, Allen Ho, MD, director of Retina Research at the Wills Eye Hospital, discussed the Protocol W values in helping establish anti-VEGF treatment initiation in at-risk patients. However, he noted limitations of a representative patient population.
He stressed the need for improved clinical trial representation in a population increasingly burdened with progressing diabetes or diabetic risk.
“One way of looking at patients…looking at a reactive or proactive way of medicine,” Ho said. “I think one of the problems we have in general in trials is that the study populations are not reflective of the general population of patients with diabetes.”
Though the findings conclude that prescribing clinicians could be “a little more reactive” in anti-VEGF administration when seeking retained vision, Ho is looking forward to outcomes beyond the two-year mark.
“One easy concept to understand is that patients don’t care about their vision just at 2 years,” Ho said. “They care about their vision from day 0, 1, 2, 3, 4…all the way out to day 700. visual acuity results at 2 years may be shorter than we want to know—and Protocol W is looking out to 4 years—and we want the visual journey over time, instead of just a slice of time.”