Evidence map›Paper›PMID 38336282›Full record

Trial reportOphthalmology2024

Risk Factors for Meeting Criteria for Switching from Bevacizumab to Aflibercept When Treating Eyes with Diabetic Macular Edema and Visual Acuity of < 20/40.

Chirag D Jhaveri, Danni Liu, Maureen G Maguire, Adam R Glassman, Ruben A Grigorian, Lee M Jampol, Ronald M Kingsley, Mathew W MacCumber, Daniel F Martin, Raj K Maturi and 3 more

Open access · greenAbstract readRandomized Controlled TrialMulticenter Study
In one paragraph

Trial report in Ophthalmology, 2024. 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
2.2field-weighted citation impact, top 15% 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, 4 citations in OpenAlex.

  1. Trial
  2. Article
  3. 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

13 authors at 9 institutions in 1 country.

Chirag D JhaveriRetina Consultants of Austin and Austin Research Center for Retina, Austin, Texas.
Danni LiuJaeb Center for Health Research, Tampa, Florida.
Maureen G MaguireJaeb Center for Health Research, Tampa, Florida.
Adam R GlassmanJaeb Center for Health Research, Tampa, Florida. Electronic address: drcrstat2@jaeb.org.
Ruben A GrigorianJoseph E. Humble and Raymond Haik PTRS DBA Eye Association of Northeast Louisiana.
Lee M JampolFeinberg School of Medicine, Northwestern University, Chicago, Illinois.
Ronald M KingsleyDean A. McGee Eye Institute, Oklahoma City, Oklahoma.
Mathew W MacCumberRush University Medical Center, Department of Ophthalmology, Chicago, Illinois.
Daniel F MartinCole Eye Institute, Cleveland Clinic, Cleveland, Ohio.
Raj K MaturiMidwest Eye Institute, and Indiana University School of Medicine, Department of Ophthalmology, Indianapolis, Indiana.
Gisela VelezValley Eye Physicians and Surgeons, Ayer, Massachusetts.
Jennifer K SunBeetham Eye Institute, Joslin Diabetes Center, Department of Ophthalmology, Harvard Medical School, Boston, Massachusetts.
DRCR Retina Network
Jaeb Center for Health Research · USCleveland Clinic · USDean McGee Eye Institute · USJoslin Diabetes Center · USMidwest Eye Institute · USNorthwestern University · USNorthwest Eye Surgeons · USRetina Consultants of Texas · USRush University Medical Center · US

Funding

DRCR Retina NetworkUG1EY014231 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI Adam R Glassman, DANIEL F MARTIN · 2019 to 2026
$75.4M
NEI NIH HHS UG1 EY014231
6 · The paper itself

Abstract

purposeTo identify factors for meeting prespecified criteria for switching from bevacizumab to aflibercept in eyes with center-involved diabetic macular edema (CI-DME) and moderate vision loss initially treated with bevacizumab in DRCR Retina Network protocol AC.

designPost hoc analysis of data from a randomized clinical trial.

participantsTwo hundred seventy participants with one or both eyes harboring CI-DME with visual acuity (VA) letter score of 69 to 24 (Snellen equivalent, 20/50-20/320).

methodsEligible eyes were assigned to receive intravitreal aflibercept monotherapy (n = 158) or bevacizumab followed by aflibercept if prespecified criteria for switching were met between 12 weeks and 2 years (n = 154).

main outcome measuresMeeting switching criteria: (1) at any time, (2) at 12 weeks, and (3) after 12 weeks. Associations between meeting the criteria for switching and factors measured at baseline and 12 weeks were evaluated in univariable analyses. Stepwise procedures were used to select variables for multivariable models.

resultsIn the group receiving bevacizumab first, older participants showed a higher risk of meeting the switching criteria at any time, with a hazard ratio (HR) for a 10-year increase in age of 1.32 (95% confidence interval [CI], 1.11-1.58). Male participants or eyes with worse baseline VA were more likely to switch at 12 weeks (for male vs. female: odds ratio [OR], 4.84 [95% CI, 1.32-17.81]; 5-letter lower baseline VA: OR, 1.30 [95% CI, 1.03-1.63]). Worse 12-week central subfield thickness (CST; 10-μm greater: HR, 1.06 [95% CI, 1.04-1.07]) was associated with increased risk of switching after 12 weeks. The mean ± standard deviation improvement in visual acuity after completing the switch to aflibercept was 3.7 ± 4.9 letters compared with the day of switching.

conclusionsThe identified factors can be used to refine expectations regarding the likelihood that an eye will meet protocol criteria to switch to aflibercept when treatment is initiated with bevacizumab. Older patients are more likely to be switched. At 12 weeks, thicker CST was predictive of eyes most likely to be switched in the future. FINANCIAL DISCLOSURE(S): Proprietary or commercial disclosure may be found in the Footnotes and Disclosures at the end of this article.

Indexed as

Angiogenesis InhibitorsBevacizumabDiabetic RetinopathyDrug SubstitutionIntravitreal InjectionsMacular EdemaReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVisual AcuityAgedDouble-Blind MethodFemaleHumansMaleMiddle AgedafliberceptAngiogenesis InhibitorsBevacizumabReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, humanAnti-VEGFDiabetic macular edemaDRCR Retina Network

Identifiers

PMID38336282
PMCPMC11260250
OpenAlexW4391649482

What OpenQuestion holds

Textmetadata
LicenceTDM
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.