Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial

Background PULSAR (NCT04423718) was a global, phase 3, randomized, double-masked, non-inferiority study of adults with neovascular age-related macular degeneration (nAMD). Patients were randomized 1:1:1 to receive aflibercept 8 mg every 12 (8q12), or 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following 3 initial monthly doses. This subgroup analysis investigated the efficacy and safety of aflibercept 8 mg vs. aflibercept 2 mg in patients from China with nAMD from the PULSAR trial. Methods This exploratory analysis evaluated the change from baseline in best-corrected visual acuity (BCVA), central retinal thickness (CRT), durability, and safety outcomes through week 48 in patients from China. All results were descriptive in nature. Results Least squares (LS) mean (95% confidence interval [CI]) change from baseline in BCVA at week 48 was + 13.2 (+9.0, +17.4), +9.7 (+5.8, +13.7), and + 10.0 (+6.9, +13.1) letters for patients from China in the 8q12 ( n = 31), 8q16 ( n = 31), and 2q8 ( n = 39) groups, respectively. LS mean (95% CI) change from baseline in CRT (µm) at week 48 was –167 (–183, −151), −166 (–195, −137), and −180 (–195, −165) for patients in the 8q12, 8q16, and 2q8 groups, respectively. Randomized dosing intervals were maintained by 88.5% and 73.1% of patients in the 8q12 and 8q16 groups, respectively. The incidence of ocular treatment-emergent adverse events was similar across treatment groups. Conclusions In patients with nAMD from China, aflibercept 8 mg administered over extended dosing intervals demonstrated efficacy and a safety profile consistent with that observed with aflibercept 2 mg, in line with the overall PULSAR cohort. Trial registration ClinicalTrials.gov, TRN NCT04423718. Registration date 8 June 2020.