Evidence map›Paper›PMID 37039948›Full record

Trial reportJapanese journal of ophthalmology2023

Efficacy, durability, and safety of faricimab up to every 16 weeks in patients with neovascular age-related macular degeneration: 1-year results from the Japan subgroup of the phase 3 TENAYA trial.

Ryusaburo Mori, Shigeru Honda, Fumi Gomi, Akitaka Tsujikawa, Hideki Koizumi, Haruka Ochi, Shino Ohsawa, Annabelle Ayame Okada, TENAYA and LUCERNE Investigators

Erratum issued Registry-linked trialOpen access · bronzeAbstract readRandomized Controlled TrialMulticenter StudyClinical Trial, Phase III
In one paragraph

Trial report in Japanese journal of ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT03823287 (A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration), which is not on this map. Cited by 28 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
28citing papers in PubMed, 1 pooled it
9.8field-weighted citation impact, top 1% of its field
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.

NCT03823287 phase3completednot on this map

A Phase III, Multicenter, Randomized, Double-Masked, Active Comparator-Controlled Study to Evaluate the Efficacy and Safety of Faricimab in Patients With Neovascular Age-Related Macular Degeneration (TENAYA)

TypeinterventionalSponsorHoffmann-La RocheRan2019 to 2022Enrolled671ConditionsWet Macular DegenerationArmsFaricimab, Aflibercept, Sham Procedure
3 · Its place in the literature

Who cites it

28 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.

  1. Pooled it
  2. Real-world durability of faricimab in treatment-naïve nAMD patients: outcomes of an observe-and-plan regimen.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2026
    Article
  3. Article
  4. Article
  5. Article
  6. Article
  7. Article
  8. Article
  9. Article
  10. One-year outcomes of three-monthly and four-monthly loading regimens of faricimab for treatment-naïve neovascular age-related macular degeneration.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2025
    Article
  11. Review
  12. Article
  13. Article
  14. Review
  15. Review
  16. Article
  17. Article
  18. Article
  19. Three-month outcomes of treatment with faricimab or aflibercept for neovascular age-related macular degeneration: a propensity score matching study in a Japanese population.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Article
  20. Faricimab for neovascular age-related macular degeneration and diabetic macular edema: from preclinical studies to phase 3 outcomes.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

9 authors at 6 institutions in 1 country.

Ryusaburo MoriDepartment of Ophthalmology, Nihon University School of Medicine, 1-6 Surugadai, Kanda, Chiyodaku, Tokyo, 101-8309, Tokyo, Japan. mori.ryusaburo@nihon-u.ac.jp.
Shigeru HondaDepartment of Ophthalmology and Visual Sciences, Graduate School of Medicine, Osaka Metropolitan University, Osaka, Japan.
Fumi GomiDepartment of Ophthalmology, Hyogo Medical University, Hyogo, Japan.
Akitaka TsujikawaDepartment of Ophthalmology and Visual Sciences, Kyoto University Graduate School of Medicine, Kyoto, Japan.
Hideki KoizumiDepartment of Ophthalmology, University of the Ryukyus, Okinawa, Japan.
Haruka OchiChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Shino OhsawaChugai Pharmaceutical Co., Ltd, Tokyo, Japan.
Annabelle Ayame OkadaDepartment of Ophthalmology, Kyorin University School of Medicine, Tokyo, Japan.
TENAYA and LUCERNE Investigators
Hyogo University · JPKyorin University · JPKyoto University · JPNihon University · JPOsaka Metropolitan UniversityUniversity of the Ryukyus · JP

Funding

Chugai Pharmaceutical Co. Chugai Pharmaceutical Co.F. Hoffmann-La Roche Ltd. F. Hoffmann-La Roche Ltd.Genentech, Inc Genentech, Inc
6 · The paper itself

Abstract

purposeTo evaluate the 1-year efficacy, durability, and safety of faricimab versus aflibercept in patients with neovascular age-related macular degeneration (nAMD) enrolled in the Japan subgroup of the TENAYA trial. STUDY

designTENAYA (NCT03823287) was a global, phase 3, multicenter, randomized, active comparator-controlled, double-masked, noninferiority, parallel-group, 112-week trial. After completion of global enrollment, additional patients were enrolled in the Japan extension of TENAYA.

methodsTreatment-naïve patients aged ≥ 50 years with nAMD were randomized (1:1) to intravitreal faricimab 6 mg up to every 16 weeks (Q16W) after 4 initial Q4W doses based on disease activity at weeks 20 and 24 or aflibercept 2 mg Q8W after 3 initial Q4W doses. Primary endpoint was mean change in best-corrected visual acuity (BCVA) from baseline averaged over weeks 40, 44, and 48. Anatomical/durability outcomes were assessed.

resultsOverall, 133 patients were included in the TENAYA Japan subgroup analysis (faricimab, n = 66; aflibercept, n = 67). The adjusted mean (95% confidence interval) BCVA changes were + 7.1 (4.6‒9.7) and + 7.7 (5.2‒10.1) letters in the faricimab and aflibercept treatment groups, respectively. At week 48, 66.1%, 22.6%, and 11.3% of patients in the faricimab group were on Q16W, Q12W, Q8W and dosing intervals, respectively. Ocular adverse event rates were similar between treatment groups (faricimab, n = 14 [21.2%] versus aflibercept, n = 17 [25.4%]).

conclusionThe TENAYA Japan subgroup analysis showed that faricimab up to Q16W had sustained efficacy with an acceptable safety profile. These findings are consistent with the global TENAYA and LUCERNE findings.

Indexed as

Macular DegenerationWet Macular DegenerationAngiogenesis InhibitorsAntibodies, BispecificHumansIntravitreal InjectionsJapanReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTreatment OutcomeVisual AcuityAngiogenesis InhibitorsAntibodies, BispecificfaricimabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAngiopoietin-2Anti-VEGF therapyChoroidal neovascularizationFaricimabNeovascular age-related macular degeneration

Identifiers

PMID37039948
PMCPMC10098238
OpenAlexW4364354542

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.