Evidence map›Paper›PMID 37697082›Full record

Observational studyInternational ophthalmology2023

Effectiveness and safety of fluocinolone acetonide intravitreal implant in diabetic macular edema patients considered insufficiently responsive to available therapies (REACT): a prospective, non-randomized, and multicenter study.

José María Ruiz-Moreno, Alfredo Adán, María Lafuente, Mónica Asencio Durán, Luís Arias Barquet, Alfredo García Layana, Javier Araiz Iribarren

Open access · hybridAbstract readObservational StudyMulticenter Study
In one paragraph

Observational study in International ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
0.8field-weighted citation impact, top 27% 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

3 citing papers in PubMed, 3 citations in OpenAlex.

  1. Article
  2. Article
  3. 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

7 authors at 6 institutions in 1 country.

José María Ruiz-MorenoPuerta de Hierro-Majadahonda University Hospital, Joaquín Rodrigo, 2, 28222, Majadahonda, Madrid, Spain. josemaria.ruiz@uclm.es.ORCID http://orcid.org/0000-0001-9636-0788
Alfredo AdánClínic University Hospital, Barcelona, Spain.
María LafuenteVirgen de la Arraixaca University Hospital, Murcia, Spain.
Mónica Asencio DuránLa Paz University Hospital, Madrid, Spain.
Luís Arias BarquetBellvitge University Hospital, Barcelona, Spain.
Alfredo García LayanaNavarra University Clinic, Navarra, Spain.
Javier Araiz IribarrenClinical Surgical Institute of Ophthalmology, Vizcaya, Spain.
Bellvitge University Hospital · ESClinica Universidad de Navarra · ESConsejo Superior de Investigaciones Científicas · ESHospital Clínic de Barcelona · ESHospital Universitario La Paz · ESHospital Universitario Virgen de la Arrixaca · ES

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo assess the effectiveness and safety of the intravitreal fluocinolone-acetonide implant (FAc-i) in patients with chronic diabetic macular edema who did not sufficiently respond to other available therapies.

methodsThis was a multicenter, prospective, non-randomized, and phase-IV observational study conducted on patients with recurrent-DME who were insufficient responders to currently available therapies (REACT-Study). The primary end-point was the mean change in best-corrected-visual-acuity from baseline to month-24 values.

resultsThirty-one eyes from 31 patients were included in the study. Mean age was 68.0 ± 7.7 years, and 10 (32.3%) were women. Study patients had received 5.3 ± 7.3 previous DME treatments before starting the study. In the overall study sample, BCVA improved from 56.1 ± 12.3 letters at baseline to 62.4 ± 17.0 letters at month-24 (p = 0.0510). The eyes with a baseline BCVA < 70 ETDRS letters had a significant improvement in BCVA from 53.2 ± 10.2 letters at baseline to 61.5 ± 17.9 letters at month-24 (p = 0.0165). In the overall study population, central-subfoveal-thickness (CST) was significantly reduced from 474.0 ± 135.1 µm at baseline to 333.4 ± 135.6 at month-24 (p < 0.0001). Similarly, macular-volume (MV) was significantly reduced from 10.7 ± 2.7 mm

conclusionsIn DME eyes who did not sufficiently respond to previous therapies, the FAc-i was associated with an improvement in visual and anatomic outcomes. There were no unexpected adverse-events. TRIAL REGISTRATION NUMBER: EudraCT identifier: 2016-001680-37.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAgedDrug ImplantsFemaleFluocinolone AcetonideGlucocorticoidsHumansIntravitreal InjectionsMaleMiddle AgedProspective StudiesDrug ImplantsFluocinolone AcetonideGlucocorticoidsCorticoidsDiabetic macular edemaFluocinolone acetonide intravitreal implantVEGF inhibitors

Identifiers

PMID37697082
PMCPMC10724319
OpenAlexW4386624033

What OpenQuestion holds

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LicenceCC BY
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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.