Phase 4 Elevatum Trial Will Observe Faricimab In Underrepresented DME Populations

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Matthew Cunningham, MD, explains the need for greater inclusion of impacted races and ethnicities in ophthalmic clinical trials.

A new phase 4 clinical trial from Genentech seeks to interpret the efficacy of its newest approved ophthalmic drug, faricimab (Vabysmo) for diabetic macular edema (DME) in patients from underrepresented populations

The Elevatum trial is enrolling Black, African American, Hispanic, Latin American and Indigenous patients with the leading cause of blindness to assess the population-based clinical efficacy and safety of intravitreal bispecific antibody Ang-2 and VEGF-A inhibitor faricimab, shortly following the drug’s approval for DME and neovascular age-related macular degeneration (nAMD) this January.

In an interview with HCPLive, Elevatum investigator Matthew Cunningham, MD, of the Florida Retina Institute, discussed the importance of what he believes to be the first industry-sponsored assessment to address the issue of representation in DME trials.

“The whole rationale for this study is that, while underrepresented populations are disproportionately affected by diabetes and at a higher risk of developing DME, there’s historically been a lack of diversity in ophthalmic clinical trials,” Cunningham said.

On the heels of the historic faricimab approval this year—which made it the first of its novel drug class approved for both DME and nAMD—Cunningham believes Elevatum is a necessary step toward proving its absolute value to patients with DME.

“In any clinical trial, the goal is to set up a new standard of care, potentially,” Cunningham said. “And standard of care is great if there’s enough representation to state the the results are transmissible across all populations.”

Underrepresented patients generally present at Cunningham’s clinic with more advanced diabetic retinopathy and a greater risk of developing DME, he explained. With robust data lacking for such patients, it’s currently impossible to confirm whether agents like faricimab are efficacious enough to compensate for these disparities.

“Who knows if we’re comparing apples to apples when we’re comparing an underrepresented patient to a Caucasian or the like,” Cunningham said. “That’s why trials like this are important, because these questions have really not been addressed in the past.”

Cunningham also spoke to to the issue of diverse patient population recruitment into clinical ophthalmology trials, noting there’s often a need to “ease the burden” that underrepresented patients face with trial inclusion standards.

“Specific to ophthalmology and diabetic trials, hemoglobin A1c has been a really big deterrent,” he explained. “A lot of patients from underrepresented populations come in with more advanced diabetic retinopathy. However, some of them come in with more highly unregulated disease—their A1c’s might be 12-15%. Cutoff for clinical trials might be 10%. So those numbers alone might sometimes exclude (them).”