Faricimab improves vision for minority patients with diabetic macular edema

Johns Hopkins researcher J. Fernando Arevalo, MD, PhD, FACS, FASRS, presents ELEVATUM, a pioneering multicountry study examining faricimab's effectiveness in treating diabetic macular edema among underrepresented minorities. The research focused on 124 patients across 40 centers in the United States, targeting individuals aged 18 and older with type 1 or type 2 diabetes.

The study specifically recruited African American, Hispanic, Native American, and Alaska Native patients with diabetic macular edema, addressing a critical gap in clinical research. Participants had visual acuity ranging from 20/40 to 20/200 and hemoglobin A1c levels up to 10-12%, designed to increase enrollment of minority populations.

Using an open-label design, patients received monthly faricimab injections for 6 months, followed by bimonthly treatments until week 56. The primary endpoint measured visual acuity improvements, with secondary endpoints including central field thickness and diabetic retinopathy score assessment.

Key findings revealed that Hispanic/Latino patients initially presented with more severe disease characteristics, including worse visual acuity and central subfield thickness. Remarkably, all patient groups demonstrated significant improvements in visual acuity and central subfield thickness, consistent with previous studies like YOSEMITE and RHINE.

The drug proved exceptionally safe, with only 2.4% of cases experiencing mild inflammation and no instances of retinal occlusive vasculitis. The study successfully demonstrated that underrepresented minorities can be effectively recruited for randomized clinical trials and can achieve meaningful treatment outcomes.

Arevalo's research highlights the importance of inclusive clinical studies and offers promising insights into diabetic macular edema treatment for diverse patient populations.