Avacincaptad Pegol Shows Sustained 2-Year GA Growth Reduction
Key Takeaways
- Multiple avacincaptad pegol dosing schedules were associated with less geographic atrophy growth than sham over two years.
- Treatment was given monthly in year 1, and participants were re-randomized at month 12 to monthly or every-other-month dosing.
- Choroidal neovascularization rates were reported. No retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation occurred.
GATHER2 was a phase 3 randomized, sham-controlled trial of avacincaptad pegol 2 mg in patients with non-center point-involving geographic atrophy secondary to AMD. During year 1, 225 patients were assigned to monthly active treatment and 222 were assigned to sham. At month 12, those originally given avacincaptad pegol were re-randomized to monthly dosing (96 patients) or every-other-month dosing (93 patients).
Among year-2 completers, 175 patients in the avacincaptad pegol group and 184 in the sham group finished follow-up. From baseline to year 2, mean geographic atrophy area growth was 4.46 mm2 with every-month dosing and 5.18 mm2 with sham. The between-group difference was 0.724 mm2, with a 95% CI of 0.133 to 1.315 and p = 0.0165, representing a 14% difference. Every-other-month dosing yielded mean growth of 4.20 mm2, with a sham difference of 0.976 mm2, a 95% CI of 0.377 to 1.575, and nominal p = 0.0015. That comparison represented a 19% difference, and both dosing schedules remained associated with lower geographic atrophy growth than sham through year 2.
Over 2 years, study-eye choroidal neovascularization occurred in 11.6% of all treated avacincaptad pegol patients and 9.0% of sham patients. No retinal vasculitis, ischemic optic neuropathy, or serious intraocular inflammation was reported during follow-up. Investigators said the 2-year findings did not indicate new safety signals compared with year 1 overall. Visual-function or quality-of-life outcomes were not reported.