Study design

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.

Outcomes

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.

Limitations

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.

Clinical significance

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.