Evidence map›Paper›PMID 25602634›Full record

Trial reportRetina (Philadelphia, Pa.)2015

Topical nepafenec in eyes with noncentral diabetic macular edema.

Scott M Friedman, Talat H Almukhtar, Carl W Baker, Adam R Glassman, Michael J Elman, Neil M Bressler, Manvi P Maker, Lee M Jampol, Michele Melia, Diabetic Retinopathy Clinical Research Network

Registry-linked trialAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in Retina (Philadelphia, Pa.), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01331005 (A Phase II Evaluation of Topical Non-steroidal Anti-inflammatories in Eyes With Non Central Involved Diabetic Macular Edema), which is not on this map. Cited by 40 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
40citing papers in PubMed, 2 pooled it
7.1field-weighted citation impact, top 3% 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.

NCT01331005 phase2completednot on this map

A Phase II Evaluation of Topical Non-steroidal Anti-inflammatories in Eyes With Non Central Involved Diabetic Macular Edema

TypeinterventionalSponsorJaeb Center for Health ResearchRan2011 to 2013Enrolled125ConditionsDiabetic Macular EdemaArmsnepafenac 0.1% drops, Nepafenac Vehicle
3 · Its place in the literature

Who cites it

40 citing papers in PubMed, 2 syntheses or guidelines pooled it, 84 citations in OpenAlex.

  1. Pooled it
  2. Topical Treatment for Retinal Degenerative Pathologies: A Systematic Review.International journal of molecular sciences · 2023
    Pooled it
  3. Trial
  4. Topical ketorolac as an adjunctive treatment with intravitreal bevacizumab in the management of diabetic macular edema: A double-masked placebo-controlled randomized clinical trial.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2021
    Trial
  5. Trial
  6. Review
  7. Article
  8. Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Article
  14. Review
  15. Article
  16. Review
  17. Article
  18. Review
  19. Diabetic Retinopathy and Diabetic Macular Edema in People With Early-Onset Diabetes.Clinical diabetes : a publication of the American Diabetes Association · 2022
    Article
  20. Observational
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

10 authors at 6 institutions in 1 country.

Scott M Friedman*Florida Retina Consultants, Lakeland, Florida; †Jaeb Center for Health Research, Tampa, Florida; ‡Paducah Retinal Center, Paducah, Kentucky; §Elman Retina Group, P.A., Philadelphia, Pennsylvania; ¶Wilmer Eye Institute, Johns Hopkins University School of Medicine, Baltimore, Maryland; **North Shore University Health System, Pritzker School of Medicine, University of Chicago, Glenview, Illinois; and ††Feinberg School of Medicine, Northwestern University, Chicago, Illinois.
Talat H Almukhtar
Carl W Baker
Adam R Glassman
Michael J Elman
Neil M Bressler
Manvi P Maker
Lee M Jampol
Michele Melia
Diabetic Retinopathy Clinical Research Network
Jaeb Center for Health Research · USCalifornia Retina Consultants · USJohns Hopkins University · USNorthShore University HealthSystem · USNorthwestern University · USPain Management Center of Paducah · US

Funding

DIABETIC RETINOPATHY CLINICAL RESEARCH NETWORK COORDINATING CENTERU10EY014231 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI GLASSMAN, ADAM R · 2002 to 2018
$91.2M
DRCR Retina NetworkUG1EY014231 · NEI · JAEB CENTER FOR HEALTH RESEARCH, INC. · PI Adam R Glassman, DANIEL F MARTIN · 2019 to 2026
$75.4M
Diabetic Retinopathy Clinical Research Network Chair GrantU10EY023207 · NEI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI JAMPOL, LEE M · 2014 to 2018
$1.8M
Diabetic Retinopathy Clinical Research Network Operations CenterU10EY018817 · NEI · JOHNS HOPKINS UNIVERSITY · PI BRESSLER, NEIL MICHAEL · 2009 to 2013
$769k
NEI NIH HHS EY023207NEI NIH HHS EY14231NEI NIH HHS EY18817NEI NIH HHS U10 EY014231NEI NIH HHS U10 EY018817NEI NIH HHS U10 EY023207NEI NIH HHS UG1 EY014231
6 · The paper itself

Abstract

purposeTo evaluate the effect of a topical, nonsteroidal antiinflammatory drug, nepafenac 0.1%, in eyes with noncentral diabetic macular edema.

methodsMulticenter, double-masked randomized trial. Individuals with good visual acuity and noncentral-involved diabetic macular edema were randomly assigned to nepafenac 0.1% (N = 61) or placebo (nepafenac vehicle, N = 64) 3 times a day for 12 months. The primary outcome was mean change in optical coherence tomography retinal volume at 12 months.

resultsMean baseline retinal volume was 7.8 mm. At 12 months, in the nepafenac and placebo groups respectively, mean change in retinal volume was -0.03 mm and -0.02 mm (treatment group difference: -0.02, 95% confidence interval: -0.27 to 0.23, P = 0.89). Central-involved diabetic macular edema was present in 7 eyes (11%) and 9 eyes (14%) at the 12-month visit (P = 0.79), respectively. No differences in visual acuity outcomes were identified. One study participant developed a corneal melt after using nepafenac in the nonstudy eye, which had a history of severe dry eye. No additional safety concerns were evident.

conclusionIn eyes with noncentral diabetic macular edema and good visual acuity, topical nepafenac 0.1% 3 times daily for 1 year likely does not have a meaningful effect on optical coherence tomography-measured retinal thickness.

Indexed as

Administration, TopicalAgedAnti-Inflammatory Agents, Non-SteroidalBenzeneacetamidesDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic RetinopathyDouble-Blind MethodFemaleHumansMacular EdemaMaleMiddle AgedOphthalmic SolutionsPhenylacetatesRetinaAnti-Inflammatory Agents, Non-SteroidalBenzeneacetamidesnepafenacOphthalmic SolutionsPhenylacetates

Identifiers

PMID25602634
PMCPMC4408212
OpenAlexW2061080968

What OpenQuestion holds

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Registered trials

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.