Early Versus Delayed Pegcetacoplan Treatment for Geographic Atrophy Secondary to Age-Related Macular Degeneration in OAKS, DERBY, and GALE

Résumé fourni par la source

PURPOSE : To report the efficacy of early versus delayed pegcetacoplan treatment in eyes with geographic atrophy (GA) secondary to age-related macular degeneration as well as the 48-month safety profile of pegcetacoplan. DESIGN : Efficacy and safety data from the phase 3 GALE open-label extension (OLE) of the phase 3 OAKS and DERBY studies, representing up to 48 months of continuous pegcetacoplan treatment, were analyzed. PARTICIPANTS : Eyes with nonsubfoveal or subfoveal GA receiving pegcetacoplan in OAKS and DERBY continued receiving pegcetacoplan at the same dosing regimen in GALE, and sham-observed eyes with nonsubfoveal or subfoveal GA in OAKS and DERBY crossed over to active treatment in GALE at the same dosing interval in those studies. METHODS : The overall population included eyes with nonsubfoveal GA and eyes with subfoveal GA. Subgroup analyses were performed on data from eyes with nonsubfoveal GA and eyes with subfoveal GA. The early treatment group comprised eyes receiving pegcetacoplan for 48 months across the OAKS, DERBY, and GALE studies. The delayed treatment group included sham-observed eyes from OAKS and DERBY which crossed over at 24 months to receive pegcetacoplan treatment for 24 months in the GALE OLE. MAIN OUTCOME MEASURES : GA area growth rate, amount of retinal tissue preserved, risk of progression to absolute scotoma, and safety. RESULTS : In the overall population, 48 continuous months of pegcetacoplan treatment reduced GA area growth rate by up to 24% compared with projected sham, translating to 1.88 mm 2 of retinal tissue. Approximately three times more retinal tissue (up to 3.16 mm 2 with monthly treatment) was preserved in eyes with nonsubfoveal GA in the early treatment group compared with eyes in the nonsubfoveal GA delayed treatment group (1.11 mm 2 ). Reduced risk of progression to absolute scotoma of all central 4 and 16 loci (32% and 43%, respectively) was observed in the overall population. GALE safety data were consistent with the findings of the OAKS and DERBY studies. CONCLUSIONS : Pegcetacoplan demonstrated effectiveness in slowing GA progression and consistent safety over 48 months. Long-term anatomic and functional outcomes support the importance of early treatment to maximize the preservation of retinal tissue and function.

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