Effect of Key Baseline Disease Characteristics on Aflibercept 8 mg Dosing Interval Extension: A Post Hoc 96-Week Analysis of PULSAR.

In 30 seconds

This exploratory post hoc analysis of the 96-week, double-masked, active-controlled, randomised PULSAR phase 3 trial examined whether baseline visual acuity, central retinal thickness (CRT), or macular neovascularization (MNV) area related to dosing intervals in patients with treatment-naïve neovascular age-related macular degeneration receiving aflibercept 8 mg. By week 96, 86.6% of patients assigned to every-12-week dosing and 78.4% assigned to every-16-week dosing had maintained or extended their randomised interval. Baseline characteristics showed no consistent trends in the every-12-week arm; in the every-16-week arm, shorter intervals tended to occur with greater baseline CRT or MNV area.

Key findings

• By week 96, 86.6% of the every-12-week group and 78.4% of the every-16-week group maintained or extended their randomised dosing interval.
• In the every-12-week group, baseline visual acuity, CRT, and MNV area showed no trends across groups defined by final dosing interval.
• In the every-16-week group, shorter final intervals tended to be associated with greater baseline CRT or MNV area, but not with baseline visual acuity.

Why it matters

The findings suggest that many patients with treatment-naïve neovascular age-related macular degeneration can sustain extended aflibercept 8 mg dosing intervals across a range of baseline disease characteristics. The observed tendency toward shorter intervals with greater CRT or MNV area in the every-16-week group may help frame expectations about interval durability, while not establishing a reliable individual prediction.

What to keep in mind

This was an exploratory post hoc analysis, and patients were grouped by their last assigned dosing interval; the observed baseline-characteristic patterns do not establish causal relationships or predict an individual patient's interval.