Comparing ABP 938 8 mg and EYLEA Aflibercept Injections for Treating Neovascular Age-related Macular Degeneration in Adults 50 and Older

What this Trial Is About

Researchers are evaluating the similarity in effectiveness between ABP 938 8 mg and aflibercept 8 mg in adults aged 50 and older with neovascular age-related macular degeneration nAMD. The trial aims to compare the change in best corrected visual acuity BCVA between these two treatments to understand their impact on vision in this condition. This is a Phase 3, randomized, double-masked clinical trial sponsored by Amgen. Participants receive intravitreal injections of either ABP 938 8 mg or aflibercept 8 mg at the start of the study, at Week 4, and at Week 8. After these initial doses, injections continue at intervals determined by disease activity, ranging from every 4 to 16 weeks, with adjustments beginning at Week 16. This treatment schedule continues through the end of the study. During the study, participants are regularly assessed for visual acuity changes, retinal fluid presence, lesion size, and adverse events. Evaluations include imaging like spectral-domain optical coherence tomography SD-OCT and fluorescein angiography FA at various time points up to Week 48. Blood samples are taken to measure drug concentrations and antibody development. Safety and immunogenicity are closely monitored throughout the study, which runs until early 2028.

A Study to Evaluate Efficacy, Safety, and Immunogenicity With ABP 938 8 mg Versus EYLEA® HD (Aflibercept) in Participants With Neovascular Age-related Macular Degeneration