JUL 11, 2018
Investigators report data from 2 randomized phase 3 trials assessing the safety and efficacy of lampalizumab, a complement factor D inhibitor, for the treatment of geographic atrophy.
The authors analyzed data from 2 separate but identically designed phase 3, double-masked, randomized trials that enrolled a total of 1,881 participants from 23 countries. Participants were aged 50 years or older and had bilateral geographic atrophy secondary to AMD. Patients were randomized to receive an intravitreal injection of lampalizumab or sham either every 4 or every 6 weeks.
The mean increase in geographic atrophy lesion size from baseline through week 48 was approximately 2 mm2 in all groups.
These findings conflict with those from the phase 2 MAHALO trial, which demonstrated a 20% reduction in geographic atrophy progression at 18 months, and a 44% reduction in patients who had the complement factor I biomarker.
This study did not address the effect of lampalizumab beyond 48 weeks. The trial excluded patients with very small or very large lesions, unilateral geographic atrophy, eyes with current or prior choroidal neovascularization or earlier stage AMD.
These large, well-designed, multicenter trials were conducted among a diverse group of patients around the globe. Lampalizumab did not seem to influence geographic atrophy progression over the course of 1 year.