OAKS and DERBY trials show pegcetacoplan significantly slows vision loss
Pegcetacoplan demonstrated significant efficacy by slowing the growth of geographic atrophy lesions compared to a sham treatment, with an acceptable safety profile, according to results of the Phase 3 OAKS and DERBY trials.
Conducted over a span of 24 months, these multicenter, double-masked studies involved patients aged 60 and above with geographic atrophy due to age-related macular degeneration (n = 1258).
Patients were randomly assigned to receive intravitreal 15 mg per 0.1 mL pegcetacoplan either monthly or every other month, or a sham treatment on the same schedule.
In the OAKS trial, patients receiving monthly injections of pegcetacoplan experienced a 21% reduction in geographic atrophy lesion growth compared to the sham group at the 12-month mark. The every-other-month treatment regimen demonstrated a significant 16% reduction in lesion growth.
The DERBY trial, though not reaching the same level of significance, also displayed promising results. Both monthly and every-other-month pegcetacoplan treatments exhibited a 12% reduction in lesion growth at 12 months compared to the sham group.
Serious ocular treatment-emergent adverse events were rare, occurring in less than 2% of patients.
Heier JS, Lad EM, Holz FG, et al; OAKS and DERBY study investigators. Pegcetacoplan for the treatment of geographic atrophy secondary to age-related macular degeneration (OAKS and DERBY): two multicentre, randomised, double-masked, sham-controlled, phase 3 trials. Lancet. 2023;402(10411):1434-1448. doi: 10.1016/S0140-6736(23)01520-9. PMID: 37865470.