Best-Corrected Visual Acuity in PULSAR Study Shows Comparable Scores at Week 48 in Subgroups

David A. Eichenbaum, MD

Credit: Retina Vitreous Associates of Florida

Aflibercept 2 mg and 8 mg improves best corrected visual acuity (BCVA) similarly between White and Asian patients, according to the PULSAR study.¹

PULSAR, a multi-center, randomized, double-masked study, focused on patients with treatment-naïve neovascular age-related macular degeneration. The investigators randomized participants at baseline into 3 groups: 2q8, 8q12, 8q16. Every group received 3 initial monthly injections, but then the 2q8 group received aflibercept 2 mg every 8 weeks, the 8q12 group received aflibercept 8 mg every 12 weeks, and the 8q12 group received aflibercept 8 mg every 16 weeks.

The study concluded at week 96, but participants had the option of extending their treatment for 1 year, making their new end date week 156. The primary endpoint was at week 46, which looked for mean change in best corrected visual acuity. Meanwhile, the second endpoint was at week 16, examining the proportion of patients without intra-retinal fluid and sub retinal fluid in center subfield.

The 127th Annual American Academy of Ophthalmology (AAO) conference in San Francisco, California featured several findings of the PULSAR trial. Jean-Francois Korobelnik, MD, of Bordeaux University Hospital had presented the session “Aflibercept 8 mg in patients with neovascular AMD: Phase 3 PULSAR Trial 96-week Results” on November 3rd, stating aflibercept 8 mg provides better outcomes than the 2 mg dose.²

The AAO conference included a poster called “Intravitreal Aflibercept 8-mg Injection in Patients With nAMD: Subgroup Analyses from the Phase 3 PULSAR Trial,” written by David A. Eichenbaum, MD, from Retina Vitreous Associates of Florida; Sobha Sivaprasad, FRCS, MBBS from Moorsfield Eye Hospital, Tobias Machewitz, and Sergio Leal, MD. The poster examined best corrected visual acuity and compared the scores with subgroups. The team found subgroups had comparable best-corrected visual acuity scores.

For instance, White and Asian participants both had +7.5 change from baseline at week 48 in the 2q8 group. Though, for the 8q16 groups, there was a change of +5 in White participants and +8.8 in Asian participants. As for the 8q12 group, White participants had a baseline change of +5.2 while Asian participants had a change of +9.3. Therefore, not all subgroups had similar baseline changes.

The investigators found that participants with baseline central subfield retinal thickness of <400 µm and ≥400 µm had increased mean best corrected visual acuity scores from baseline. Moreover, the scores at week 48 were similar in all 3 groups. Ultimately, the findings of the study showed that best corrected visual acuity improved from baseline.

References

1. ^{Eichenbaum, D, Sivaprasad, S, Machewitz, T, et. al. Intravitreal Aflibercept 8-mg Injection in Patients With nAMD: Subgroup Analyses from the Phase 3 PULSAR Trial. Presented at the 2023 American Academy of Ophthalmology Annual Meeting, November 3 – 6, 2023.}
2. ^{Korobelnik, J. Aflibercept 8 mg in Patients with Neovascular AMD: Phase 3 PULSAR Trial 96-Week Results. Presented at the 2023 American Academy of Ophthalmology Annual Meeting; November 3, 2023; California, San Francisco.}