Evidence map›Paper›PMID 29470308›Full record

Trial reportRetina (Philadelphia, Pa.)2019

EFFICACY AND SAFETY OUTCOMES OF INTRAVITREAL AFLIBERCEPT FOCUSING ON PATIENTS WITH DIABETIC MACULAR EDEMA FROM JAPAN.

Hiroko Terasaki, Kunihiko Shiraki, Masahito Ohji, Carola Metzig, Thomas Schmelter, Oliver Zeitz, Olaf Sowade, Masato Kobayashi, Robert Vitti, Alyson Berliner and 1 more

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Retina (Philadelphia, Pa.), 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04288232 (A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing 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.

NCT04288232 phase3completednot on this map

A Multicenter, Open-label, Prospective, Interventional Study to Assess the Efficacy and Safety of Aflibercept as Mono-therapy in Treat and Extend Regimen for DME Patients in Taiwan

TypeinterventionalSponsorTaipei Veterans General Hospital, TaiwanRan2015 to 2017Enrolled45ConditionsCenter-involved Diabetic Macular EdemaArmsAflibercept Injection [Eylea]
3 · Its place in the literature

Who cites it

5 citing papers in PubMed.

  1. Trial
  2. Review
  3. Article
  4. Article
  5. Review
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

11 authors.

Hiroko TerasakiDepartment of Ophthalmology, Nagoya University Hospital, Nagoya, Japan.
Kunihiko ShirakiDepartment of Ophthalmology and Visual Sciences, Osaka City University, Osaka, Japan.
Masahito OhjiDepartment of Ophthalmology, Shiga University of Medical Science, Otsu, Japan.
Carola MetzigBayer AG, Berlin, Germany.
Thomas SchmelterBayer AG, Berlin, Germany.
Oliver ZeitzBayer AG, Berlin, Germany.
Olaf SowadeBayer AG, Berlin, Germany.
Masato KobayashiBayer Pharmaceuticals, Osaka, Japan.
Robert VittiRegeneron Pharmaceuticals, Tarrytown, New York.
Alyson BerlinerRegeneron Pharmaceuticals, Tarrytown, New York.
Fumio ShiragaDepartment of Ophthalmology, Okayama University Medical School, Okayama, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo evaluate the efficacy and safety of intravitreal aflibercept injection (IAI) in Japanese patients with diabetic macular edema (DME).

methodsVIVID-DME was a Phase 3 study comprising patients with DME randomized 1:1:1 to IAI 2 mg every 4 weeks (2q4), IAI 2 mg every 4 weeks until Week 16 then 8-week dosing (2q8), and laser. A total of 403 patients (76 Japanese) were included in this study. VIVID-Japan (72; all Japanese patients) was a nonrandomized, open-label study comprising Japanese patients with DME receiving IAI 2q4 until Week 16, then 2q8. Primary efficacy endpoint (Week 52) of VIVID-DME was mean change from baseline in best-corrected visual acuity; VIVID-Japan evaluated safety and tolerability.

resultsMean change in best-corrected visual acuity (letters) for 2q4, 2q8, and laser groups was +10.6, +10.9, and +1.2 and +9.8, +9.5, and +1.1 in the non-Japanese and Japanese populations of VIVID-DME, respectively. In VIVID-Japan, it was +9.3 for IAI 2q8. Intravitreal aflibercept injection also provided consistently greater benefits for anatomical outcomes versus laser. Adverse events were consistent with the known safety profile of IAI.

conclusionIn Japanese patients with DME, IAI treatment was superior to laser for visual and anatomical outcomes and resulted in efficacy and safety outcomes similar to those in a non-Japanese patient population.

Indexed as

Visual AcuityAgedDiabetic RetinopathyDose-Response Relationship, DrugDouble-Blind MethodFemaleFollow-Up StudiesHumansIntravitreal InjectionsJapanMacula LuteaMacular EdemaMaleMiddle AgedReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID29470308
PMCPMC6510325

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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.