Abstract
Purpose :
The effect of treatment on the primary endpoint in patients aged ≥50 years with treatment-naïve neovascular age-related macular degeneration (nAMD) in the PULSAR (NCT04423718) ongoing, double-masked, 96-week, Phase 3 trial was determined for clinically relevant subgroups.
Methods :
Patients were randomly assigned 1:1:1 to receive intravitreal aflibercept 8 mg every 12 or 16 weeks (8q12, 8q16) or 2 mg every 8 weeks (2q8), each after three initial monthly injections. The primary endpoint was change from baseline in best-corrected visual acuity (BCVA) at Week 48. Subgroups were determined post hoc and subgroup analyses were exploratory.
Results :
Mean changes from baseline in BCVA at Week 48 were numerically larger in patients with lower baseline BCVA (≤54 letters), and smaller in those with higher baseline BCVA (≥74 letters), as anticipated. Within the baseline subgroups, mean changes and absolute BCVA letter scores at Week 48 were similar in the 8q12, 8q16 and 2q8 treatment groups. Mean increases from baseline in BCVA with 8q12, 8q16 and 2q8 were also similar, with overlapping CIs, in patients with baseline central subfield retinal thickness (CRT) <400 µm and ≥400 µm, again resulting in similar absolute BCVA letter scores at Week 48 irrespective of treatment group. The same trends were also observed in the subgroup of patients with minimally classic, occult, and predominantly classic disease. Data will also be presented for additional patient subgroups, including by race.
Conclusions :
In patients with nAMD, BCVA gains from baseline at Week 48 were seen in all subgroups based on baseline BCVA, CRT, and lesion type, with comparable BCVA letter scores at Week 48 achieved with aflibercept 8 mg and 2 mg.
This abstract was presented at the 2023 ARVO Annual Meeting, held in New Orleans, LA, April 23-27, 2023.