Aflibercept 8mg noninferior to Aflibercept 2mg in nAMD Treatment: PULSAR Trial
New research revealed that aflibercept 8 mg was non-inferior to aflibercept 2 mg and provided more significant therapeutic benefit, prolonged injection interval, and similar safety compared to aflibercept 2 mg. The study was presented at the 2023 ARVO Annual Meeting and published in the journal Investigative Ophthalmology and Visual Science.
Neovascular age-related macular degeneration, also known as exudative or wet AMD is a common, progressive retinal degenerative macular disease that is characterized by neovascularization of the choroid, mainly affecting the elderly population leading to gradual vision impairment. Anti-VEGF is the main modality of the treatment of nAMD. Aflibercept, a 115 kDa completely human recombinant fusion protein that binds to VEGF-A, VEGF-B, and placental growth factor (PlGF), is made up of the immunoglobulin binding domains of VEGF receptors 1 and 2. Recent literature has shown that aflibercept 2mg can be used for naïve neovascular age-related macular degeneration (nAMD). Hence researchers conducted a trial to evaluate the efficacy and safety of intravitreal aflibercept 8 mg injection administered every 12 (8q12) or 16 weeks (8q16) for the management of treatment-naïve neovascular age-related macular degeneration (nAMD).
PULSAR trial is an ongoing, double-masked, 96-week, Phase 3 trial that recruited patients aged ≥50 years with nAMD. Participants were randomly assigned 1:1:1 to receive 8q12, 8q16, or 2q8 of aflibercept 8 mg injection and 2mg injection. The best-corrected visual acuity (BCVA) change from baseline and measured at Week 48 by a non-inferiority margin at four letters was considered as the primary endpoint. The key secondary endpoint was the proportion of patients with no intraretinal/subretinal fluid (IRF/SRF) in the central subfield at Week 16, and other secondary endpoints included safety. The proportion of patients with ≥12-week and 16-week treatment intervals through Week 48 was the Exploratory endpoint.
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