Evidence map›Paper›PMID 39083147›Full record

Trial reportJapanese journal of ophthalmology2024

Efficacy, durability, and safety of faricimab with extended dosing up to every 16 weeks in diabetic macular edema: 2-year results from the Japan subgroup of the phase 3 YOSEMITE trial.

Masahiko Shimura, Hideyasu Oh, Tetsuo Ueda, Shigehiko Kitano, Yoshinori Mitamura, Junko Sato, Keisuke Iwasaki, Akito Hirakata, YOSEMITE and RHINE Investigators

2 registry-linked trialsAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Japanese journal of ophthalmology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 14 papers.

0numbers the graph read from it
0cells of the map it votes in
14citing 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.

NCT03622580 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (YOSEMITE)

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2021Enrolled940ConditionsDiabetic Macular EdemaArmsAflibercept, Faricimab, Sham Procedure
NCT03622593 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab (RO6867461) in Patients With Diabetic Macular Edema (RHINE)

TypeinterventionalSponsorHoffmann-La RocheRan2018 to 2023Enrolled951ConditionsDiabetic Macular EdemaArmsAflibercept, Faricimab, Sham Procedure
3 · Its place in the literature

Who cites it

14 citing papers in PubMed.

  1. Racial and ethnic disparities in faricimab injections: a propensity matched cohort study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
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  3. A real-world study of Faricimab: efficacy and biomarkers in treatment-experienced neovascular age-related macular degeneration(nAMD) and diabetic macular edema (DME) patients.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  4. Early macular choroidal hemodynamic changes after faricimab loading in treatment-naïve diabetic macular edema.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
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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

9 authors.

Masahiko ShimuraTokyo Medical University Hachioji Medical Center, 1163, Tatemachi, Hachioji-shi, Tokyo, 193-0998, Japan. masahiko@v101.vaio.ne.jp.ORCID http://orcid.org/0000-0001-5456-6374
Hideyasu OhHyogo Prefectural Amagasaki General Medical Center, Hyogo, Japan.
Tetsuo UedaNara Medical University Hospital, Nara, Japan.
Shigehiko KitanoTokyo Women's Medical University Hospital, Tokyo, Japan.
Yoshinori MitamuraTokushima University Graduate School, Tokushima, Japan.
Junko SatoChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Keisuke IwasakiChugai Pharmaceutical Co., Ltd., Tokyo, Japan.
Akito HirakataKyorin University School of Medicine, Tokyo, Japan.
YOSEMITE and RHINE Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the 2-year efficacy, durability, and safety of faricimab in patients with diabetic macular edema (DME) in the YOSEMITE Japan subgroup. STUDY

designYOSEMITE/RHINE (NCT03622580/NCT03622593) subgroup analysis: global, multicenter, randomized, double-masked, active-comparator-controlled, phase 3 faricimab trials.

methodsPatients were randomized 1:1:1 to intravitreal faricimab 6.0 mg every 8 weeks (Q8W) and per treat-and-extend (T&E) dosing, or aflibercept 2.0 mg Q8W. Outcomes were assessed through year 2 for the YOSEMITE Japan subgroup (N = 60) and the pooled YOSEMITE/RHINE global cohort (N = 1891).

resultsIn the YOSEMITE Japan subgroup, 21, 19, and 20 patients were randomized to faricimab Q8W, faricimab T&E, and aflibercept Q8W, respectively (632, 632, and 627 patients in the pooled YOSEMITE/RHINE cohort). Vision gains and anatomic improvements with faricimab at year 1 were maintained over 2 years and were generally consistent between groups. Mean best-corrected visual acuity changes from baseline at year 2 (weeks 92-100 average) for the YOSEMITE Japan subgroup were +12.5, +9.0, and +5.0 letters in the faricimab Q8W, faricimab T&E and aflibercept Q8W arms, respectively (+10.8, +10.4, and +10.3 letters in the pooled YOSEMITE/RHINE cohort). At week 96, 61.1% of the YOSEMITE Japan subgroup and 78.1% of the pooled YOSEMITE/RHINE cohort were on ≥ Q12W dosing. Faricimab was well-tolerated with a safety profile comparable with aflibercept.

conclusionFaricimab up to Q16W offered durable vision gains and anatomic improvements up to 2 years in patients with DME in the YOSEMITE Japan subgroup. Outcomes were generally consistent with the pooled YOSEMITE/RHINE cohort.

Indexed as

Angiogenesis InhibitorsDiabetic RetinopathyDose-Response Relationship, DrugIntravitreal InjectionsMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVisual AcuityAgedAntibodies, Monoclonal, HumanizedDouble-Blind MethodDrug Administration ScheduleFemaleFollow-Up StudiesHumansJapanafliberceptAngiogenesis InhibitorsAntibodies, Monoclonal, HumanizedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AAngiopoietin-2Anti-VEGF therapyDiabetic macular edemaFaricimabVascular stability

Identifiers

PMID39083147
PMCPMC11420323

What Socratic holds

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LicenceCC BY
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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 Socratic graph.