Evidence map›Paper›PMID 33559843›Full record

ArticleJapanese journal of ophthalmology2021

Treat-and-extend therapy with aflibercept for diabetic macular edema: a prospective clinical trial.

Takao Hirano, Yuichi Toriyama, Yoshihiro Takamura, Masahiko Sugimoto, Taiji Nagaoka, Yoshimi Sugiura, Fumiki Okamoto, Michiyuki Saito, Kousuke Noda, Shigeo Yoshida and 3 more

Abstract readMulticenter Study
PubMed Publisher
In one paragraph

Article in Japanese journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.

0numbers the graph read from it
0cells of the map it votes in
11citing papers in PubMed
0.7field-weighted citation impact, top 33% 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.

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

11 citing papers in PubMed, 8 citations in OpenAlex.

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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

13 authors at 9 institutions in 1 country.

Takao HiranoDepartment of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan. takaoh@shinshu-u.ac.jp.
Yuichi ToriyamaDepartment of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Yoshihiro TakamuraDepartment of Ophthalmology, Faculty of Medical Sciences, University of Fukui, Fukui, Japan.
Masahiko SugimotoDepartment of Ophthalmology, Mie University Graduate School of Medicine, Mie, Japan.
Taiji NagaokaDepartment of Ophthalmology, Nihon University Itabashi Hospital, Tokyo, Japan.
Yoshimi SugiuraDepartment of Ophthalmology, University of Tsukuba, Faculty of Medicine, Ibaraki, Japan.
Fumiki OkamotoDepartment of Ophthalmology, University of Tsukuba, Faculty of Medicine, Ibaraki, Japan.
Michiyuki SaitoDepartment of Ophthalmology, Hokkaido University School of Medicine, Hokkaido, Japan.
Kousuke NodaDepartment of Ophthalmology, Hokkaido University School of Medicine, Hokkaido, Japan.
Shigeo YoshidaDepartment of Ophthalmology, Kurume University School of Medicine, Fukuoka, Japan.
Akihiro IshibazawaDepartment of Ophthalmology, Asahikawa Medical University, Hokkaido, Japan.
Osamu SawadaDepartment of Ophthalmology, Shiga University of Medical Science, Shiga, Japan.
Toshinori MurataDepartment of Ophthalmology, Shinshu University School of Medicine, 3-1-1 Asahi, Matsumoto, Nagano, 390-8621, Japan.
Shinshu University · JPHokkaido University · JPUniversity of Tsukuba · JPAsahikawa Medical University · JPKurume University · JPMie University · JPNihon University Itabashi Hospital · JPShiga University of Medical Science · JPUniversity of Fukui · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

purposeTo investigate the efficacy and safety of a treat-and-extend (T&E) regimen using aflibercept (Eylea) for diabetic macular edema (DME). STUDY

designProspective, open-label, multicenter, single-arm, nonblinded clinical study.

methodsForty eyes of 40 patients with DME received a T&E regimen of intravitreal aflibercept injection (IAI) with the longest treatment interval set to 16 weeks and adjunct focal/grid laser for 1 year. An intent-to-treat analysis was performed using the same last-observation-carried-forward method. A per-protocol analysis was also performed for patients who completed a 1-year T&E regimen. The primary endpoints were mean changes in best-corrected visual acuity (BCVA) and central subfield macular thickness (CST) from baseline. Secondary endpoints included IAI-interval extension and resultant IAI numbers and the association between an early response to IAI and final BCVA gain at 1 year.

resultsThirty-one patients (77.5%) completed the 1-year aflibercept T&E regimen. In these per-protocol participants, the mean CST improvement/reduction was 187.3 ± 145.0 µm (P < .001), but the mean BCVA gain was limited to 4.3 ± 12.2 letters (P = .782). Subanalysis revealed that eyes that gained ≥ 4 letters (median at week 12) after the initial 3 consecutive IAIs (induction phase) achieved greater vision improvement (13.8 ± 9.5 letters) than did the residual eyes (- 4.3 ± 9.2 letters) at 1 year (P < .001). Treatment intervals were extended to 12 and 16 weeks in 16.1% (5/31) and 45.2% (14/31) of the patients, respectively. The mean IAI number was 7.0 ± 1.1.

conclusionsThe results of this study suggest that although the BCVA improvement might be somewhat less than that of frequent treatment, a T&E aflibercept regimen with the longest treatment interval set to 16 weeks is a realizable rational strategy for DME treatment over 1 year.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsHumansIntravitreal InjectionsLaser CoagulationProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AAfliberceptDiabetic macular edemaFocal/grid photocoagulationTreat-and-extend

Identifiers

PMID33559843
OpenAlexW3128148953

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.