Evidence map›Paper›PMID 35739147›Full record

Trial reportScientific reports2022

Randomized clinical trial comparing intravitreal aflibercept combined with subthreshold laser to intravitreal aflibercept monotherapy for diabetic macular edema.

Tomoaki Tatsumi, Yoko Takatsuna, Toshiyuki Oshitari, Tomomi Kaiho, Yohei Kawasaki, Yuki Shiko, Takeshi Sugawara, Takayuki Baba, Shuichi Yamamoto

Open access · goldAbstract readClinical Trial, Phase IVRandomized Controlled Trial
In one paragraph

Trial report in Scientific reports, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed, 3 pooled it
2.2field-weighted citation impact, top 13% 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

8 citing papers in PubMed, 3 syntheses or guidelines pooled it, 13 citations in OpenAlex.

  1. Pooled it
  2. Efficacy of anti-VEGF monotherapy versus anti-VEGF therapy with subthreshold micropulse laser (SML) in the management of diabetic macular oedema (DMO): a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it
  3. Pooled it
  4. Review
  5. Article
  6. Review
  7. Review
  8. Current Treatments for Diabetic Macular Edema.International journal of molecular sciences · 2023
    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

9 authors at 2 institutions in 1 country.

Tomoaki TatsumiDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan. ttatsumi@chiba-u.jp.
Yoko TakatsunaDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan. yoko_takatsuna@chibah.johas.go.jp.
Toshiyuki OshitariDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan.
Tomomi KaihoDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan.
Yohei KawasakiBiostatistics Section, Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan.
Yuki ShikoBiostatistics Section, Clinical Research Center, Chiba University Hospital, 1-8-1 Inohana, Chuo-ku, Chiba, 260-8670, Japan.
Takeshi SugawaraDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan.
Takayuki BabaDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan.
Shuichi YamamotoDepartment of Ophthalmology and Visual Science, Chiba University Graduate School of Medicine, 1-8-1, Inohana, Chuo-ku, Chiba, Chiba, 260-8670, Japan.
Chiba University · JPChiba University Hospital · JP

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

To compare the efficacy and safety of intravitreal aflibercept with three loading doses + pro re nata regimen combined with subthreshold laser application to that of IVA monotherapy on eyes with diabetic macular edema. This was a phase 4 clinical trial with a prospective, randomized, and parallel investigator-driven protocol. Patients with DME were randomly assigned to the IVA monotherapy group (n = 25) or the IVA + SL combination therapy group (n = 26). The main outcome measures were the number of IVA injections and the changes in the best-corrected visual acuity (BCVA) and the central retinal thickness (CRT) at the final evaluation at 96 weeks. The mean number of IVA injections in the monotherapy group was 5.86 ± 2.43 and it was 6.05 ± 2.73 in the IVA + SL group at 96 weeks, and this difference was not significant (P = 0.83). The differences in the mean changes of the CRT (P = 0.17) and the BCVA (P = 0.31) were also not significant between the two groups throughout the follow-up period. We conclude that adjunct of SL to anti-VEGF therapy does not reduce the number of necessary intravitreal injections.

Indexed as

Angiogenesis InhibitorsDiabetes MellitusDiabetic RetinopathyLaser TherapyMacular EdemaHumansIntravitreal InjectionsProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTomography, Optical CoherenceTreatment OutcomeVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID35739147
PMCPMC9226173
OpenAlexW4283395258

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.