Evidence map›Paper›PMID 41452565›Full record

Trial reportJapanese journal of ophthalmology2026

Intravitreal aflibercept 8 mg in patients from Japan with neovascular age-related macular degeneration: 48-week subgroup analysis of the PULSAR trial.

Hideki Koizumi, Shigeru Honda, Tsutomu Yasukawa, Genichiro Kishino, Tetsuju Sekiryu, Andrea Schulze, Takuto Yamashita, Ursula Schmidt-Ott, Min Zhao, Xin Zhang and 10 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IIIMulticenter Study
In one paragraph

Trial report in Japanese journal of ophthalmology, 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. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04423718 phase3completednot on this map

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

TypeinterventionalSponsorBayerRan2020 to 2024Enrolled1,011ConditionsNeovascular Age-Related Macular DegenerationArmsAflibercept High Dose VEGF Trap-Eye (BAY86-5321), Aflibercept VEGF Trap-Eye (Eylea, BAY86-5321)
3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Five-year real-world outcomes and patterns of MNV-related atrophy after anti-VEGF therapy in eyes with pathologic myopia.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Hideki KoizumiDepartment of Ophthalmology, Graduate School of Medicine, University of the Ryukyus, Okinawa, Japan.
Shigeru HondaDepartment of Ophthalmology and Visual Sciences, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
Tsutomu YasukawaDepartment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Genichiro KishinoKozawa Eye Hospital and Diabetes Center, Ibaraki, Japan.
Tetsuju SekiryuDepartment of Ophthalmology, Fukushima Medical University, Fukushima, Japan.
Andrea SchulzeBayer AG, Berlin, Germany.
Takuto YamashitaBayer Yakuhin, Ltd., Osaka, Japan.
Ursula Schmidt-OttBayer AG, Berlin, Germany.
Min ZhaoBayer Healthcare Co. Ltd., Beijing, China.
Xin ZhangBayer Consumer Care AG, Basel, Switzerland.
Alyson J BerlinerRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Karen W ChuRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Kimberly ReedRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Yenchieh ChengRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Rafia BhoreRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Robert VittiRegeneron Pharmaceuticals, Inc., Tarrytown, NY, USA.
Ikuko FujitaBayer Yakuhin, Ltd., Osaka, Japan.
Sergio LealBayer Consumer Care AG, Basel, Switzerland.
Tomohiro IidaDepartment of Ophthalmology, Tokyo Women's Medical University, Shinjuku-ku, Tokyo, Japan. iida.twmu@gmail.com.
PULSAR investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the 1-year efficacy and safety of aflibercept 8 mg compared with aflibercept 2 mg in a pre-specified analysis of patients from Japan with neovascular age-related macular degeneration (nAMD) included in PULSAR. STUDY

designPULSAR (NCT04423718) was a global, phase 3, randomized, double-masked, non-inferiority study of adults with nAMD. Patients were randomized 1:1:1 to receive aflibercept 8 mg every 12 weeks (8q12), or every 16 weeks (8q16), or aflibercept 2 mg every 8 weeks (2q8), following three initial monthly doses in all groups.

methodsThis subgroup analysis of Japan and non-Japan cohorts from PULSAR evaluated changes from baseline in best-corrected visual acuity (BCVA), central subfield retinal thickness, durability and safety outcomes.

resultsIn the Japan subgroup, least squares (LS) mean (95% CI) changes from baseline in BCVA at week 48 were +6.5 (+0.7, +12.3), +7.9 (+5.1, +10.6), and +4.7 (-0.5, +9.9) letters for patients in the 8q12 (n = 31), 8q16 (n = 33), and 2q8 (n = 33) groups, respectively. The majority of patients in the 8q12 (82.1%) and 8q16 (93.8%) groups maintained their randomized dosing intervals through Week 48. Ocular treatment-emergent adverse events were reported in 35.5%, 30.3%, and 39.4% of patients in the Japan subgroup in 8q12, 8q16, and 2q8 groups, respectively. Similar efficacy and safety results were observed in the non-Japan subgroup.

conclusionAflibercept 8 mg has similar efficacy and safety to aflibercept 2 mg when administered at extended dosing intervals in both the Japan and non-Japan subgroups, consistent with the overall PULSAR results.

Indexed as

Receptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityWet Macular DegenerationAgedAged, 80 and overAngiogenesis InhibitorsDose-Response Relationship, DrugDouble-Blind MethodFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsJapanafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AAfliberceptAnti-VEGF agentNeovascular age-related macular degenerationVascular endothelial growth factor

Identifiers

PMID41452565
PMCPMC12948824

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.