Evidence map›Paper›PMID 18662829›Full record

Trial reportOphthalmology2008

A randomized trial comparing intravitreal triamcinolone acetonide and focal/grid photocoagulation for diabetic macular edema.

Diabetic Retinopathy Clinical Research Network

Registry-linked trialOpen access · greenAbstract readClinical Trial, Phase IIIComparative StudyMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Ophthalmology, 2008. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00367133 (A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema), which is not on this map. Cited by 207 papers, 6 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
207citing papers in PubMed, 6 pooled it
58.2field-weighted citation impact, top 1% 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.

NCT00367133 phase3completednot on this map

A Randomized Trial Comparing Intravitreal Triamcinolone Acetonide and Laser Photocoagulation for Diabetic Macular Edema

TypeinterventionalSponsorJaeb Center for Health ResearchRan2004 to 2008Enrolled840ConditionsDiabetic Macular EdemaArmsStandard of Care Group, 1mg triamcinolone acetonide, 4mg triamcinolone acetonide
3 · Its place in the literature

Who cites it

207 citing papers in PubMed, 6 syntheses or guidelines pooled it, 545 citations in OpenAlex.

  1. Subthreshold micropulse laser combined with anti-vascular endothelial growth factor therapy for diabetic macular edema: a systematic review and meta-analysis.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2024
    Pooled it
  2. Intravitreal steroids for macular edema in diabetes.The Cochrane database of systematic reviews · 2020
    Pooled it
  3. Pooled it
  4. Guideline
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  6. Diabetic retinopathy (treatment).BMJ clinical evidence · 2011
    Pooled it
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  10. Efficacy and safety of ranibizumab 0.5 mg in Chinese patients with visual impairment due to diabetic macular edema: results from the 12-month REFINE study.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2019
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  15. Changes in aqueous concentrations of various cytokines after intravitreal bevacizumab and subtenon triamcinolone injection for diabetic macular edema.Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2018
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147 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

1 author at 1 institution in 1 country.

Diabetic Retinopathy Clinical Research NetworkJaeb Center for Health Research, Tampa, FL 33647, USA. drcrnetB3@jaeb.org
Jaeb Center for Health Research · 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 NetworkU10EY014229 · NEI · UNIVERSITY OF WISCONSIN-MADISON · PI DANIS, RONALD · 2002 to 2008
$2.4M
Diabetic Retinopathy Clinical Research Network Chair GrantU10EY023207 · NEI · NORTHWESTERN UNIVERSITY AT CHICAGO · PI JAMPOL, LEE M · 2014 to 2018
$1.8M
Study Chair Core Center:DME Clinical Research NetworkU10EY014269 · NEI · JOSLIN DIABETES CENTER · PI AIELLO, LLOYD P · 2002 to 2005
$1.1M
The application of nanotechnology to the retinaK08EY017112 · NEI · UNIVERSITY OF HOUSTON · PI FOSTER, WILLIAM JOSEPH · 2006 to 2010
$950k
NEI NIH HHS EY14229NEI NIH HHS EY14231NEI NIH HHS EY14269NEI NIH HHS K08 EY017112NEI NIH HHS U10 EY014229NEI NIH HHS U10 EY014231NEI NIH HHS U10 EY014269NEI NIH HHS U10 EY023207NEI NIH HHS UG1 EY014231
6 · The paper itself

Abstract

objectiveTo evaluate the efficacy and safety of 1-mg and 4-mg doses of preservative-free intravitreal triamcinolone in comparison with focal/grid photocoagulation for the treatment of diabetic macular edema (DME).

designMulticenter, randomized clinical trial.

participantsEight hundred forty study eyes of 693 subjects with DME involving the fovea and with visual acuity of 20/40 to 20/320.

methodsEyes were randomized to focal/grid photocoagulation (n = 330), 1 mg intravitreal triamcinolone (n = 256), or 4 mg intravitreal triamcinolone (n = 254). Retreatment was given for persistent or new edema at 4-month intervals. The primary outcome was evaluated at 2 years.

main outcome measuresVisual acuity measured with the electronic Early Treatment Diabetic Retinopathy Study method (primary), optical coherence tomography-measured retinal thickness (secondary), and safety.

resultsAt 4 months, mean visual acuity was better in the 4-mg triamcinolone group than in either the laser group (P<0.001) or the 1-mg triamcinolone group (P = 0.001). By 1 year, there were no significant differences among groups in mean visual acuity. At the 16-month visit and extending through the primary outcome visit at 2 years, mean visual acuity was better in the laser group than in the other 2 groups (at 2 years, P = 0.02 comparing the laser and 1-mg groups, P = 0.002 comparing the laser and 4-mg groups, and P = 0.49 comparing the 1-mg and 4-mg groups). Treatment group differences in the visual acuity outcome could not be attributed solely to cataract formation. Optical coherence tomography results generally paralleled the visual acuity results. Intraocular pressure increased from baseline by 10 mmHg or more at any visit in 4%, 16%, and 33% of eyes in the 3 treatment groups, respectively, and cataract surgery was performed in 13%, 23%, and 51% of eyes in the 3 treatment groups, respectively.

conclusionsOver a 2-year period, focal/grid photocoagulation is more effective and has fewer side effects than 1-mg or 4-mg doses of preservative-free intravitreal triamcinolone for most patients with DME who have characteristics similar to the cohort in this clinical trial. The results of this study also support that focal/grid photocoagulation currently should be the benchmark against which other treatments are compared in clinical trials of DME.

Indexed as

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic RetinopathyFemaleGlucocorticoidsHumansInjectionsLaser CoagulationMacular EdemaMaleMiddle AgedPreservatives, PharmaceuticalRetreatmentTomography, Optical CoherenceTreatment OutcomeTriamcinolone AcetonideGlucocorticoidsPreservatives, PharmaceuticalTriamcinolone Acetonide

Identifiers

PMID18662829
PMCPMC2748264
OpenAlexW2805868637

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.