Evidence map›Paper›PMID 25107900›Full record

Trial reportThe British journal of ophthalmology2015

Efficacy and safety of intravitreal aflibercept injection in wet age-related macular degeneration: outcomes in the Japanese subgroup of the VIEW 2 study.

Yuichiro Ogura, Hiroko Terasaki, Fumi Gomi, Mitsuko Yuzawa, Tomohiro Iida, Miki Honda, Koichi Nishijo, Olaf Sowade, Tetsushi Komori, Ursula Schmidt-Erfurth and 3 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00637377 (A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration), which is not on this map. Cited by 30 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 3 pooled it
–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.

NCT00637377 phase3completednot on this map

A Randomized, Double Masked, Active Controlled, Phase 3 Study of the Efficacy, Safety, and Tolerability of Repeated Doses of Intravitreal VEGF Trap in Subjects With Neovascular Age-related Macular Degeneration (AMD)

TypeinterventionalSponsorBayerRan2008 to 2011Enrolled1,240ConditionsMacular DegenerationArmsRanibizumab, Aflibercept Injection (EYLEA, VEGF Trap-Eye, BAY86-5321)
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Aflibercept for neovascular age-related macular degeneration.The Cochrane database of systematic reviews · 2016
    Pooled it
  4. Trial
  5. Trial
  6. Review
  7. Article
  8. Article
  9. Article
  10. Review
  11. Article
  12. Review
  13. Review
  14. Article
  15. Article
  16. Article
  17. Observational
  18. Tachyphylaxis during treatment of exudative age-related macular degeneration with aflibercept.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2019
    Article
  19. Article
  20. Observational
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

13 authors.

Yuichiro OguraDepartment of Ophthalmology and Visual Science, Nagoya City University Graduate School of Medical Sciences, Nagoya, Japan.
Hiroko TerasakiDepartment of Ophthalmology, Nagoya University Graduate School of Medicine, Nagoya, Japan.
Fumi GomiDepartment of Ophthalmology, Osaka University Graduate School of Medicine, Osaka, Japan.
Mitsuko YuzawaDepartment of Ophthalmology, Nihon University School of Medicine, Tokyo, Japan.
Tomohiro IidaDepartment of Ophthalmology, Tokyo Women's Medical University, Tokyo, Japan.
Miki HondaDepartment of Ophthalmology, Juntendo University Urayasu Hospital, Chiba, Japan.
Koichi NishijoBayer Yakuhin, Ltd., Osaka, Japan.
Olaf SowadeBayer HealthCare Pharmaceuticals, Berlin, Germany.
Tetsushi KomoriBayer Yakuhin, Ltd., Osaka, Japan.
Ursula Schmidt-ErfurthDepartment of Ophthalmology and Optometry, Medical University of Vienna, Vienna, Austria.
Christian SimaderVienna Reading Center (VRC), Medical University of Vienna, Vienna, Austria.
Victor ChongOxford Eye Hospital, University of Oxford, Oxford, UK.
VIEW 2 Investigators

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimsTo evaluate efficacy and safety of intravitreal aflibercept (IVT-AFL) in Japanese patients with wet age-related macular degeneration (wAMD) from the VIEW 2 trial.

methodsIn this double-masked study, patients were randomised to: 0.5 mg IVT-AFL every 4 weeks (0.5q4); 2 mg IVT-AFL every 4 weeks (2q4); 2 mg IVT-AFL every 8 weeks (2q8) after 3 monthly injections; or 0.5 mg ranibizumab every 4 weeks (Rq4). Main efficacy outcomes included vision maintenance and best-corrected visual acuity (BCVA) at week 52.

resultsAt week 52, all Japanese patients in the IVT-AFL groups (n=70) maintained vision, compared with 96% of Japanese patients (n=23/24) treated with ranibizumab. Japanese patients in all treatment groups showed improvement in BCVA after treatment. The Rq4, 2q4 and 2q8 groups experienced similar gains in BCVA from baseline. The 0.5q4 group had higher gains due to an unexpected drop in BCVA between screening and baseline. Central retinal thickness and mean area of choroidal neovascularisation decreased in all treatment groups with similar magnitude. Ocular treatment-emergent adverse events were balanced across treatment groups.

conclusionsIVT-AFL was effective and well tolerated in Japanese patients. Outcomes in this population were consistent with those in the overall VIEW 2 population. TRIAL REGISTRATION NUMBER: NCT00637377.

Indexed as

AgedAged, 80 and overAsian PeopleDouble-Blind MethodFemaleFluorescein AngiographyHumansIntravitreal InjectionsJapanMaleMiddle AgedProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTomography, Optical CoherenceTreatment OutcomeafliberceptReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAngiogenesisClinical TrialMaculaNeovascularisationRetina

Identifiers

PMID25107900
PMCPMC4283691

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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.