Evidence map›Paper›PMID 31320738›Full record

Trial reportEye (London, England)2020

Relationship between duration and extent of oedema and visual acuity outcome with ranibizumab in diabetic macular oedema: A post hoc analysis of Protocol I data.

Srinivas R Sadda, Joanna Campbell, Pravin U Dugel, Nancy M Holekamp, Szilárd Kiss, Anat Loewenstein, Albert J Augustin, Vanessa Shih, Xiaoshu Xu, Charles C Wykoff and 1 more

Open access · hybridAbstract readClinical Trial, Phase IRandomized Controlled Trial
In one paragraph

Trial report in Eye (London, England), 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 32 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 1 pooled it
4.6field-weighted citation impact, top 5% 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

32 citing papers in PubMed, 1 synthesis or guideline pooled it, 48 citations in OpenAlex.

  1. Pooled it
  2. Trial
  3. Trial
  4. Trial
  5. Article
  6. Review
  7. Review
  8. Article
  9. Inflammatory Biomarkers in Diabetic Macular Edema.Journal of clinical medicine · 2026
    Review
  10. Article
  11. Article
  12. Article
  13. Review
  14. Anti-VEGF therapy for the long-term management of diabetic macular edema: a treat-to-target strategy based on macular morphology.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Review
  15. Article
  16. Article
  17. Article
  18. Review
  19. Article
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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

11 authors at 8 institutions in 3 countries.

Srinivas R SaddaDoheny Eye Institute, Los Angeles, CA, USA. SSadda@doheny.org.
Joanna CampbellAllergan plc, Irvine, CA, USA.
Pravin U DugelRetinal Consultants of Arizona, Phoenix, AZ, USA.
Nancy M HolekampPepose Vision Institute and Washington University School of Medicine, St. Louis, MO, USA.
Szilárd KissWeill Cornell Medical College, New York, NY, USA.
Anat LoewensteinDepartment of Ophthalmology, Tel Aviv Medical Center and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel.
Albert J AugustinDepartment of Ophthalmology, Staedtisches Klinikum Karlsruhe, Karlsruhe, Germany.ORCID http://orcid.org/0000-0003-1591-0536
Vanessa ShihAllergan plc, Irvine, CA, USA.
Xiaoshu XuAllergan plc, Irvine, CA, USA.
Charles C WykoffRetina Consultants of Houston, Blanton Eye Institute, Houston Methodist Hospital, Houston, TX, USA.
Scott M WhitcupJules Stein Eye Institute, David Geffen School of Medicine at UCLA, Los Angeles, CA, USA.
Allergan (United States) · USDoheny Eye Institute · USCornell University · USHouston Methodist · USPepose Vision Institute · USStädtisches Klinikum Karlsruhe · DETel Aviv University · ILUniversity of Southern California · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesThis post hoc analysis explores the relationship between residual oedema exposure after ranibizumab treatment initiation and long-term visual acuity outcome in eyes with centre-involved diabetic macular oedema (DMO). SUBJECTS/

methodsEyes randomised to the ranibizumab + prompt or deferred laser treatment arms in the Protocol I trial and with observed central retinal thickness (CRT) readings at baseline and ≥1 follow-up visits (n = 367) were stratified by 1) oedema duration (number of study visits with CRT ≥ 250 µm during the first 52 weeks of ranibizumab treatment); and 2) oedema extent (amount of excess CRT [≥ 250 µm] at each study visit, averaged over the first 52 weeks). Associations between measures of residual oedema and best-corrected visual acuity (BCVA) were assessed in multiple regression analyses.

resultsOedema duration and oedema extent during the first 52 weeks of ranibizumab treatment showed significant negative associations with BCVA improvement at weeks 52, 104 and 156. Eyes with the most persistent oedema gained (mean) 4.4 (95% CI 0.1─8.7) fewer Early Treatment Diabetic Retinopathy Study (ETDRS) letters at week 156 than eyes with the least persistent oedema (P = 0.044). Eyes with the greatest amount of oedema gained (mean) 9.3 (95% CI 4.0─14.5) fewer ETDRS letters at week 156 than eyes with the least amount of oedema (P < 0.001).

conclusionsMacular oedema exposure over the first 52 weeks of ranibizumab treatment is a negative prognostic factor for long-term visual acuity improvement in centre-involved DMO.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsEdemaHumansIntravitreal InjectionsRanibizumabTomography, Optical CoherenceTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityAngiogenesis InhibitorsRanibizumabVascular Endothelial Growth Factor A

Identifiers

PMID31320738
PMCPMC7042302
OpenAlexW2958970461

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.