Evidence map›Paper›PMID 26581718›Full record

Trial reportThe British journal of ophthalmology2016

Anatomical effects of dexamethasone intravitreal implant in diabetic macular oedema: a pooled analysis of 3-year phase III trials.

Ronald P Danis, Srinivas Sadda, Xiao-Yan Li, Harry Cui, Yehia Hashad, Scott M Whitcup

2 registry-linked trialsOpen access · hybridAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in The British journal of ophthalmology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 19 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
19citing papers in PubMed, 1 pooled it
2.6field-weighted citation impact, top 11% 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.

NCT00168337 phase3completednot on this map

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

TypeinterventionalSponsorAllerganRan2005 to 2012Enrolled554ConditionsDiabetic Macular EdemaArmsDexamethasone, Sham
NCT00168389 phase3completednot on this map

A Study of the Safety and Efficacy of a New Treatment for Diabetic Macular Edema

TypeinterventionalSponsorAllerganRan2005 to 2012Enrolled494ConditionsDiabetic Macular EdemaArmsDexamethasone, Sham
3 · Its place in the literature

Who cites it

19 citing papers in PubMed, 1 synthesis or guideline pooled it, 39 citations in OpenAlex.

  1. Pooled it
  2. Natural history of diabetic macular edema and factors predicting outcomes in sham-treated patients (MEAD study).Graefe's archive for clinical and experimental ophthalmology = Albrecht von Graefes Archiv fur klinische und experimentelle Ophthalmologie · 2019
    Trial
  3. Review
  4. Review
  5. Article
  6. Article
  7. Article
  8. Article
  9. Recent Advancements in the Medical Treatment of Diabetic Retinal Disease.International journal of molecular sciences · 2021
    Review
  10. Review
  11. Review
  12. Review
  13. Review
  14. Cataract in diabetes mellitus.World journal of diabetes · 2019
    Review
  15. Article
  16. Review
  17. Review
  18. Article
  19. Review
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

6 authors at 3 institutions in 1 country.

Ronald P DanisDepartment of Ophthalmology and Visual Sciences, University of Wisconsin-Madison, Madison, Wisconsin, USA.
Srinivas SaddaDoheny Image Reading Center, Doheny Eye Institute, Los Angeles, California, USA.
Xiao-Yan LiAllergan, Inc., Irvine, California, USA.
Harry CuiAllergan, Inc., Irvine, California, USA.
Yehia HashadAllergan, Inc., Irvine, California, USA.
Scott M WhitcupAllergan, Inc., Irvine, California, USA.
Allergan (United States) · USDoheny Eye Institute · USUniversity of Wisconsin–Madison · US

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

aimTo assess long-term effects of dexamethasone intravitreal implant (DEX implant) monotherapy on retinal morphology in diabetic macular oedema (DME).

methodsTwo multicentre, masked, phase III studies with identical protocols randomised patients with DME, best-corrected visual acuity of 34-68 Early Treatment Diabetic Retinopathy Study letters and central subfield retinal thickness (CSRT) ≥300 µm to DEX implant 0.7, 0.35 mg or sham procedure. Patients were followed up for 3 years (39 months if treated at month 36), with retreatment allowed at ≥6-month intervals. Patients needing other macular oedema (ME) therapy exited the study. Changes from baseline in CSRT, macular volume and ME grade, area of retinal thickening, macular leakage, macular capillary loss and diabetic retinopathy severity were assessed.

resultsAfter 3 years, more eyes treated with DEX implant 0.7 and 0.35 mg than sham showed improvement (although small) in ME grade (p<0.05 vs sham). DEX implant 0.7 mg delayed time to onset of two-step progression in diabetic retinopathy severity by ∼12 months. DEX implant 0.7 and 0.35 mg produced small, non-sustained reductions in macular leakage but had no significant effect on macular capillary loss.

conclusionsDEX implant 0.7 or 0.35 mg, administered at ≥6-month intervals over 3 years, produced sustained retinal structural improvement in DME. TRIAL REGISTRATION NUMBER: NCT00168337 and NCT00168389.

Indexed as

DexamethasoneDiabetic RetinopathyDose-Response Relationship, DrugDouble-Blind MethodDrug ImplantsFollow-Up StudiesGlucocorticoidsHumansIntravitreal InjectionsMacular EdemaRetinaTime FactorsTomography, Optical CoherenceTreatment OutcomeVisual AcuityVitreous BodyDexamethasoneDrug ImplantsGlucocorticoidsAnatomyClinical TrialDrugsImagingRetina

Identifiers

PMID26581718
PMCPMC4893085
OpenAlexW2172579108

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC
Read underepoch 390

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.