Dr Charles Wykoff discussed the study design and key findings from the GALE study, an extension of the pivotal phase 3 OAKS and DERBY trials for pegcetacoplan in geographic atrophy.
This is a video synopsis of a discussion involving Charles C. Wykoff, MD, PhD, where he provides insights into the GALE study, presenting one-year data on the long-term utilization of pegcetacoplan (complement C3 inhibitor) in patients with geographic atrophy (GA). Dr. Wykoff, a retina specialist in Houston, Texas, notes the study's presentation at the American Academy of Ophthalmology in 2023.
The GALE trial serves as a 36-month long-term extension study following the DERBY and OAKS trials, which led to the FDA approval of pegcetacoplan in February 2023 for managing GA. In GALE, patients from DERBY and OAKS were offered the opportunity to continue treatment, creating an open-label extension.
The study design involved three treatment arms: monthly pegcetacoplan, every other month pegcetacoplan, and a sham arm, with patients crossing over to active treatment after completing DERBY and OAKS. Notably, 83% of patients from DERBY and OAKS continued into GALE.
Analyzing the efficacy data, Dr. Wykoff highlights a consistent reduction in GA lesion growth through month 36 with continuous pegcetacoplan treatment. The data shows a 35% reduction with monthly dosing and a 24% reduction with every other month dosing in the last 12 months.
Safety data from GALE aligns with preceding trials, with adverse events including AMD development, intraocular inflammation, ischemic optic neuropathy, and infectious endophthalmitis. The cumulative rate of wet AMD development through three years is about 19.5% with monthly dosing and less than 9% with every other month dosing.
Intraocular inflammation occurred in 0.7% to 3.9% of arms, predominantly mild cases treated with local steroids. Ischemic optic neuropathy and infectious endophthalmitis rates were low, emphasizing the overall safety profile.
Dr. Wykoff concludes by noting the absence of reported cases of vasculitis or retinitis in GALE to date. The synopsis provides a comprehensive overview of the GALE study, emphasizing both efficacy and safety outcomes related to the extended use of pegcetacoplan in GA treatment.
Video synopsis is AI-generated and reviewed by Modern Retina® editorial staff.