Evidence map›Paper›PMID 32783421›Full record

Trial reportKorean journal of ophthalmology : KJO2020

Prospective Clinical Trial of Intravitreal Aflibercept Treat-and-extend Regimen for Diabetic Macular Edema: 1-Year Outcomes.

Hiroki Mieno, Kazuhito Yoneda, Nobuhiro Terao, Kengo Yoshii, Kentaro Kojima, Kenji Nagata, Chie Sotozono

Abstract readRandomized Controlled Trial
In one paragraph

Trial report in Korean journal of ophthalmology : KJO, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 4 papers.

0numbers the graph read from it
0cells of the map it votes in
4citing 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

4 citing papers in PubMed.

  1. Trial
  2. Article
  3. Article
  4. 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

7 authors.

Hiroki MienoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kazuhito YonedaDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan. kazuyone@koto.kpu-m.ac.jp.
Nobuhiro TeraoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kengo YoshiiDepartment of Mathematics and Statistics in Medical Sciences, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kentaro KojimaDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Kenji NagataDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.
Chie SotozonoDepartment of Ophthalmology, Kyoto Prefectural University of Medicine, Kyoto, Japan.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the efficacy of aflibercept for the treatment of diabetic macular edema via a treat-and-extend regimen.

methodsThis prospective, single-center, open-label, interventional study involved 30 patients with a best-corrected visual acuity (BCVA) ≤0.6 and a central retinal thickness (CRT) ≥300 μm. The enrolled eyes each received a monthly intravitreal aflibercept injection until the CRT decreased below 300 μm, upon which the administration interval was extended for 1 month until the CRT once again increased to ≥300 μm. Main outcome measures were median BCVA and CRT at 6 and 12 months after initiation of treatment via last observation carried forward analysis, the median number of injections over the 12 months, and the effects on the diabetic retinopathy severity scale (DRSS) score of the patients who completed the 12-month follow-up period.

resultsOf the 30 enrolled patients, 29 and 25 respectively completed the 6- and 12-month follow-up examinations. From baseline to 6 and 12 months after treatment initiation, the median BCVA (logarithm of the minimum angle of resolution) significantly improved from 0.52 to 0.30 and 0.35, respectively, and the median CRT significantly decreased from 439.5 to 268.5 and 249.0 μm, respectively. The median number of injections over the 12-month follow-up period was 6.0. Compared to baseline, the DRSS score at 12 months was improved by 2 steps in 16% of patients; in no cases did the DRSS score worsen or improve by three steps or more.

conclusionsWhen administered in a treat-and-extend regimen, aflibercept is an effective treatment option for diabetic macular edema.

Indexed as

Visual AcuityAgedAngiogenesis InhibitorsDiabetic RetinopathyFemaleFluorescein AngiographyFollow-Up StudiesFundus OculiHumansIntravitreal InjectionsMacular EdemaMaleMiddle AgedProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsAfliberceptIntravitreal injectionsMacular edema

Identifiers

PMID32783421
PMCPMC7419240

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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.