ArticleInternational journal of retina and vitreous2026
Intravitreal aflibercept 8 mg in patients with neovascular age-related macular degeneration from China: 48-week results from the PULSAR trial.
Article in International journal of retina and vitreous, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04423718 (Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration), which is not on this map. Not yet cited in PubMed.
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Randomized, Double-Masked, Active-Controlled, Phase 3 Study of the Efficacy and Safety of High Dose Aflibercept in Patients With Neovascular Age-Related Macular Degeneration
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17 authors.
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Abstract
backgroundPULSAR (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.
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