Evidence map›Paper›PMID 33253664›Full record

Trial reportAmerican journal of ophthalmology2021

Retinal Fluid Volatility Associated With Interval Tolerance and Visual Outcomes in Diabetic Macular Edema in the VISTA Phase III Trial.

Justis P Ehlers, Atsuro Uchida, Duriye Damla Sevgi, Ming Hu, Kim Reed, Alyson Berliner, Robert Vitti, Karen Chu, Sunil K Srivastava

Abstract readClinical Trial, Phase IIIComparative StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of ophthalmology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing 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

8 citing papers in PubMed.

  1. Trial
  2. Trial
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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

9 authors.

Justis P EhlersTony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA. Electronic address: ehlersj@ccf.org.
Atsuro UchidaTony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Duriye Damla SevgiTony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Ming HuTony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Department of Quantitative Health Sciences, Lerner Research Institute, Cleveland Clinic, Cleveland, Ohio, USA.
Kim ReedRegeneron, Tarrytown, New York, USA.
Alyson BerlinerRegeneron, Tarrytown, New York, USA.
Robert VittiRegeneron, Tarrytown, New York, USA.
Karen ChuRegeneron, Tarrytown, New York, USA.
Sunil K SrivastavaTony and Leona Campane Center for Excellence in Image-Guided Surgery and Advanced Imaging Research, Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA; Cole Eye Institute, Cleveland Clinic, Cleveland, Ohio, USA.

Funding

RESOURCE/SERVICE CORE C - MOLECULAR INFORMATICS MODULEP30EY025585 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI BELA ANAND-APTE · 2016 to 2026
$7.7M
Intraoperative Optical Coherence Tomography for Ophthalmic SurgeryK23EY022947 · NEI · CLEVELAND CLINIC LERNER COM-CWRU · PI EHLERS, JUSTIS · 2013 to 2017
$1.0M
NEI NIH HHS K23 EY022947NEI NIH HHS P30 EY025585
6 · The paper itself

Abstract

purposeTo describe longitudinal retinal fluid dynamics on spectral domain OCT and to identify imaging biomarkers that predict the worsening of DME with interval extension during anti-vascular endothelial growth factor (VEGF) therapy.

designA post hoc sub-analysis of phase III, VISTA-DME study.

methodsEyes received either intravitreal aflibercept injection 2 mg every 4 weeks (2q4) or every 8 weeks after 5 initial monthly injections (2q8), and eyes imaged with the Cirrus HD-OCT system were included. The macular cube was analyzed for 10 time-points from baseline through week 100. Retinal OCT images were evaluated using a novel software platform to extract retinal fluid features for calculation of volumetric fluid parameters, including the retinal fluid index (RFI): the percentage of retinal volume that was occupied by intraretinal fluid.

resultsFifty-five eyes were included in the 2q4 group, and 58 eyes were included in the 2q8 group. Early RFI volatility with a central macular RFI increase by ≥5 points from week 4 to 8 (P = .004, odds ratio [OR] 31.3, 95% confidence interval [CI] 3.0 to 329) and cumulative RFI volatility with an aggregate increase in macular RFI by ≥10 points from those timepoints with increased RFI between baseline to week 20, P = .005, OR 10.2, 95% CI 2.1 to 51.3) were both significant predictors for the worsening of DME and visual acuity when the treatment interval was extended to 8 weeks in the 2q8 group.

conclusionsEarly fluid dynamics as measured by (1) early RFI volatility and (2) cumulative RFI instability with aggregate increased RFI were associated with intolerance of interval extension.

Indexed as

AdultAgedAged, 80 and overAngiogenesis InhibitorsDiabetic RetinopathyDouble-Blind MethodFemaleFluorescein AngiographyFollow-Up StudiesHumansIntravitreal InjectionsLaser CoagulationMacular EdemaMaleMiddle AgedReceptors, Vascular Endothelial Growth FactorafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID33253664
PMCPMC9307417

What OpenQuestion holds

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Registered trials

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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.