Purpose: To evaluate 1-year efficacy and safety of aflibercept 8 mg in Asian patients with neovascular age-related macular degeneration (nAMD) in the PULSAR (NCT04423718) trial. Design: Subgroup analysis of the Phase 3 PULSAR trial. Methods: Patients aged >= 50 years with nAMD were randomized to receive intravitreal aflibercept 8 mg every 12 (8q12) or 16 (8q16) weeks, or aflibercept 2 mg every 8 weeks (2q8), following 3 initial monthly injections. Outcomes included change from baseline in best-corrected visual acuity (BCVA) and central subfield retinal thickness (CRT), durability, and safety at week (W) 48. Findings: Overall, 234 Asian patients participated and received study treatment (8q12 [n = 74], 8q16 [n = 77], and 2q8 [n = 83]). At W48, the least squares (LS) mean (95 % CI) BCVA change from baseline was +9.9 (6.9, 12.9), +9.2 (7.1, 11.2), and +7.6 (4.7, 10.5) letters in the 8q12, 8q16, and 2q8 groups, respectively. The LS mean (95 % CI) change in CRT from baseline to W48 for the 8q12, 8q16, and 2q8 groups was -141 (-152, -129), -156 (-167, -146), and -142 (-155, -129) mu m, respectively. Most patients receiving 8q12 (85 %) or 8q16 (87 %), maintained their randomized dosing interval, through W48. The safety profile of aflibercept 8 mg was comparable to aflibercept 2 mg. Conclusions: Aflibercept 8 mg was effective and well tolerated in Asian patients with nAMD, with demonstrated improvements in functional and anatomic outcomes comparable to aflibercept 2 mg at W48. Aflibercept 8 mg outcomes were achieved with fewer injections than with aflibercept 2 mg, consistent with overall PULSAR results.
[1]Sydney Retina Clin, Level 13,187 Macquarie St, Sydney, NSW 2000, Australia.
[2]Shanghai Gen Hosp, Shanghai, Peoples R China.
[3]Tokyo Womens Med Univ, Dept Ophthalmol, Shinjuku Ku, Tokyo, Japan.
[4]Chinese Univ Hong Kong, Dept Ophthalmol & Visual Sci, Hong Kong, Peoples R China.
[5]Singapore Natl Eye Ctr, Singapore Eye Res Inst, Singapore, Singapore.
[6]Tsinghua Univ, Beijing Tsinghua Changgung Hosp, Beijing Visual Sci & Translat Eye Res Inst BERI, Sch Clin Med, Beijing, Peoples R China.
[7]Natl Univ Singapore, Duke NUS Med Sch, Singapore, Singapore.
[8]Nune Eye Hosp, Seoul, South Korea.
[9]Bayer Consumer Care AG, Basel, Switzerland.
[10]Bayer AG, Berlin, Germany.
[11]Bayer Healthcare Co Ltd, Beijing, Peoples R China.
[12]Bayer Australia Ltd, Pymble, NSW, Australia.
[13]Taipei Vet Gen Hosp, Dept Ophthalmol, Taipei City, Taiwan.
[14]Natl Yang Ming Chiao Tung Univ, Taipei City, Taiwan.
(8.0+极速模式)