Asia-Pacific journal of ophthalmology (Philadelphia, Pa.) · 2026
Intravitreal aflibercept 8 mg versus 2 mg in Asian patients with neovascular age-related macular degeneration: 48-week analysis of the Phase 3 PULSAR trial.
СтатьяРандомизированное исследованиеКлиническое исследование III фазыМногоцентровое исследованиеНазвание и аннотация: Перевод пока не подготовлен
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Chang Andrew, Sun Xiaodong, Iida Tomohiro, Lai Timothy Y Y, Wong Tien Y, Cheung Chui Ming Gemmy, Lee Won Ki, Zhang Xin, Schulze Andrea, Schmidt-Ott Ursula Maria, Zhao Min, Hasanbasic Zoran, Leal Sergio, Chen Shih-Jen, PULSAR study investigators
Аннотация
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) µm, 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.
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) µm, 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.
Предметные рубрики MeSH
HumansRecombinant Fusion ProteinsReceptors, Vascular Endothelial Growth FactorIntravitreal InjectionsMaleFemaleAgedVisual AcuityMiddle AgedWet Macular DegenerationAngiogenesis InhibitorsTreatment OutcomeTomography, Optical CoherenceDose-Response Relationship, DrugAged, 80 and overFollow-Up StudiesDouble-Blind MethodVascular Endothelial Growth Factor AAsian PeopleTime FactorsFluorescein Angiography