| Title: |
Aflibercept 8 mg in Polypoidal Choroidal Vasculopathy ; Post Hoc Analysis of the PULSAR Randomized Clinical Trial |
| Authors: |
Lee, Won Ki; Wong, Tien Y.; Chen, Shih-Jen; Sun, Xiaodong; Cheung, Chui Ming Gemmy; Silva, Rufino; Ricci, Federico; Zhang, Xin; Machewitz, Tobias; Schulze, Andrea; Schmidt-Ott, Ursula M.; Zhao, Min; Hasanbasic, Zoran; Leal, Sergio; Iida, Tomohira; Schlottmann, Patricio; Zompa, Tamara; Alezzandrini, Arturo; Chang, Andrew; Arnold, Jennifer; Fraser-Bell, Samantha; Luckie, Alan; Verma, Nitin; El-Shabrawi, Yosuf; Reinelt, Peter; Findl, Oliver; Haas, Anton; Bolz, Matthias; Daskalov, Veselin; Mitova, Daniela; Blagoeva, Hristina; Grupcheva, Hristina; Oscar, Aleksandar; Petkova, Iva; Andreev, Andrei; Sheidow, Thomas; Koushan, Keyvan; Gauvin, Louis-Pierre; Zhang 张, Mingchang 明昌; Fan 范, Ke 珂; Chen 陈, Xueyi 雪艺; Han, Mei; Dai, Hong; Xiao 肖, Jun 骏; Yang杨, Wenhui 文慧; Sun 孙, Xufang 旭芳; Liu 刘, Xiaoling 晓玲; Ha 哈, Shaoping 少平; Zhang 张, Jing Lin 静琳 |
| Source: |
JAMA Ophthalmology ; volume 144, issue 2, page 129 ; ISSN 2168-6165 |
| Publisher Information: |
American Medical Association (AMA) |
| Publication Year: |
2026 |
| Description: |
Importance In the Study of the Effects of High-Dose Aflibercept Injected Into the Eye of Patients With an Age-Related Disorder That Causes Loss of Vision Due to Growth of Abnormal Blood Vessels at the Back of the Eye (PULSAR) phase 3 randomized clinical trial, treatment with aflibercept, 8 mg, demonstrated noninferior (4-letter margin) best-corrected visual acuity (BCVA) gains vs aflibercept, 2 mg, in participants with neovascular age-related macular degeneration (nAMD). This post hoc subgroup analysis evaluated clinical outcomes in participants with polypoidal choroidal vasculopathy (PCV). Objective To compare the efficacy and safety of aflibercept, 8 mg vs 2 mg, monotherapy among participants with PCV in the PULSAR trial. Design, Setting, and Participants This was a post hoc subgroup analysis of the PULSAR randomized clinical trial. The setting included hospitals and clinics in 12 countries where indocyanine green angiography (ICGA) was performed to identify PCV. Included were a subgroup of adults with nAMD enrolled in the PULSAR trial with ICGA-confirmed PCV. Study data were analyzed from August 2020 to July 2022. Interventions Participants were randomly assigned 1:1:1 to aflibercept, 8 mg, every 12 weeks or 16 weeks, or aflibercept, 2 mg, every 8 weeks, each after 3 initial monthly doses. From week 16, dosing intervals in the treatment arms receiving 8 mg every 12 weeks and every 16 weeks were shortened if predefined disease activity criteria were met at prespecified visits. Main Outcomes and Measures Least-squares (LS) mean change in BCVA from baseline at week 48. Results A total of 139 participants were included in this analysis. ICGA-confirmed PCV was present in 44 participants in the treatment group receiving aflibercept, 8 mg, every 12 weeks (mean [SD] age, 72.2 [8.1] years; 50% male), 41 participants receiving 8 mg every 16 weeks (mean [SD] age, 73.2 [8.7] years; 63% male), and 54 participants receiving 2 mg every 8 weeks (mean [SD] age, 72.6 [8.2] years; 69% male). Mean baseline BCVA letter score ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| DOI: |
10.1001/jamaophthalmol.2025.5098 |
| Availability: |
https://doi.org/10.1001/jamaophthalmol.2025.5098; https://jamanetwork.com/journals/jamaophthalmology/articlepdf/2842906/jamaophthalmology_lee_2025_oi_250078_1770917820.9764.pdf |
| Accession Number: |
edsbas.6877E23A |
| Database: |
BASE |