Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial
摘要
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.
MethodsThis 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.
ResultsLeast 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.
ConclusionsIn 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 registrationClinicalTrials.gov, TRN NCT04423718. Registration date 8 June 2020.