Subjects

• Major Inclusion Criteria:
  • Patients must self-identify as Black/African American, Hispanic/Latino American, or Native American/Alaska Native/Native Hawaiian or other Pacific Islander, or self-identify as Asian Indian residents of the Indian subcontinent
  • Treated diabetes with hemoglobin A1c ≤ 10% (up to 20% enrolled, though, may have A1c up to 12%)
  • Treatment-naïve DME on OCT and BCVA score of 73 to 20 letters
• Major Exclusion Criteria:
  • Untreated diabetes or previously untreated diabetes who started on new diabetic medication within 3 months of treatment
  • Stroke or myocardial infarction within 12 months of study
  • High-risk PDR in the study eye or VMT or ERM in the study eye
  • History of PRP, focal laser, or history of intravitreal injections or periocular steroids in the study eye

Study Interventions

• In the main phase, patients receive intravitreal injection of faricimab 6mg q4 weeks up to week 20, followed by faricimab 6mg q8 weeks up to week 52
• Eligible patients in the United States who opt to continue into the long-term extension will receive intravitreal faricimab 6mg according to the personalized treatment interval (PTI) dosing algorithm
• In the long-term extension phase, the minimum and maximum PTIs are q4 weeks and q24 weeks

Results

• The primary outcome is change in BCVA through week 56 for the main phase of the study
• The primary outcome for the long-term extension phase is the incidence and severity of adverse events
• Initial data from 124 participants in the US (45% Hispanic or Latino, 48% Black or African American) showed that at week 56, patients gained an average of 12 letters
• Results were similar among major and ethnic groups. Hispanic and Latino patients started the study with the most severe disease and gained an average of 14 letters. African American and Black patients gained an average of 11 letters

Conclusions

• ELEVATUM is an ongoing phase 4 open-label, single-arm study to investigate faricimab treatment response in treatment-naïve, underrepresented patients with diabetic macular edema (DME) where patients received intravitreal faricimab 6mg q4 weeks up to week 20, followed by faricimab 6mg q8 weeks up to week 52
• For the primary outcome of change in BCVA through week 56, initial data from 124 participants showed that patients gained an average of 12 letters
• Results were similar among major and ethnic groups--Hispanic and Latino patients had the most severe disease and gained an average of 14 letters while African American and Black patients gained an average of 11 letters