The following is a summary of “Intravitreal Aflibercept 8-mg Injection in Patients With nAMD: Subgroup Analyses From the Phase 3 PULSAR Trial,” published in the issue of Ophthalmology 2023 by Eichenbaum et al.
Researchers performed a prospective study to investigate how baseline characteristics affect vision outcomes in neovascular AMD patients in the PULSAR trial.
Patients were randomly assigned in a 1:1:1 ratio to receive either intravitreal aflibercept 8 mg every 12/16 weeks (8q12, 8q16) or 2 mg every 8 weeks ( 2q8) following three initial monthly injections. Subgroups were defined after the fact, and these subgroups’ analysis was exploratory.
At Week 48, patients with lower (≤54 letters) initial BCVA had larger improvements compared to those with higher (≥74 letters) baseline BCVA. The mean changes and absolute BCVA scores at Week 48 were consistent across the 8q12, 8q16, and 2q8 groups. This pattern was also observed in subgroups based on baseline central subfield retinal thickness (CRT), with CRT <400 µm and ≥400 µm showing similar BCVA improvements with 8q12, 8q16, and 2q8—the same trends held for subgroups with minimally classic, occult, and predominantly classic diseases.
The study found BCVA improvements from baseline and BCVA scores at Week 48 were consistent with 8q12, 8q16, and 2q8 dosing.