Evidence map›Paper›PMID 37541745›Full record

Observational studyBMJ open ophthalmology2023

Dexamethasone intravitreal implant in diabetic macular oedema refractory to anti-vascular endothelial growth factors: the AUSSIEDEX study.

Paul Mitchell, Jennifer Arnold, Samantha Fraser-Bell, Hyong Kwon Kang, Andrew A Chang, Jodi Tainton, Susan Simonyi

Registry-linked trialOpen access · goldAbstract readObservational Study
PubMed Full text at PMC Publisher
In one paragraph

Observational study in BMJ open ophthalmology, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02731911 (Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study), which is not on this map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
5.3field-weighted citation impact, top 4% 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.

NCT02731911 completednot on this map

Phase 4, Open-label, Non-randomized, Prospective Study of OZURDEX® in the Treatment of Diabetic Macular Oedema - The AUSSIEDEX Study

TypeobservationalSponsorAllerganRan2016 to 2018Enrolled202ConditionsDiabetic Macular OedemaArmsdexamethasone intravitreal implant
3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 19 citations in OpenAlex.

  1. Review
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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

7 authors at 4 institutions in 5 countries.

Paul MitchellWestmead Institute for Medical Research / Sydney West Retina, University of Sydney, Sydney, New South Wales, Australia paul.mitchell@sydney.edu.au.
Jennifer ArnoldMarsden Eye Research, Sydney, New South Wales, Australia.
Samantha Fraser-BellThe University of Sydney Save Sight Institute, Sydney, New South Wales, Australia.ORCID 0000-0001-5646-9359
Hyong Kwon KangRetina & Vitreous Centre, Sydney, New South Wales, Australia.
Andrew A ChangSydney Retina Clinic & Day Surgery, Sydney, New South Wales, Australia.ORCID 0000-0001-7555-1585
Jodi TaintonAllergan, an AbbVie Company, Gordon, New South Wales, Australia.
Susan SimonyiAllergan, an AbbVie company, Singapore.ORCID 0000-0002-1236-4026
The University of Sydney · AUAbbVie (Ireland) · IEAbbVie (United States) · USRetina Clinic · BR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

aimTo evaluate effectiveness of dexamethasone intravitreal implant 0.7 mg (DEX) monotherapy in the AUSSIEDEX study non-responder subgroup, defined by diabetic macular oedema (DME) refractory to anti-vascular endothelial growth factor (anti-VEGF) agents.

methodsThis prospective, open-label, observational, real-world study included pseudophakic and phakic (scheduled for cataract surgery) eyes that did not achieve a ≥5-letter best corrected visual acuity (BCVA) gain and/or clinically significant central subfield retinal thickness (CRT) improvement after 3-6 anti-VEGF injections for DME (N=143 eyes), regardless of baseline BCVA and CRT. After an initial DEX injection (baseline visit), reinjection was permitted at ≥16-week intervals. PRIMARY ENDPOINTS: changes in mean BCVA and CRT from baseline to week 52. Safety assessments included adverse events.

resultsOf 143 eyes, 53 (37.1%) and 89 (62.2%) switched to DEX after 3-6 (early) and >6 (late) anti-VEGF injections, respectively; 1 (0.7%) had missing information. With 2.3 injections (mean) over 52 weeks, the change in mean BCVA from a baseline of 57.8 letters was not significant at week 52. Mean CRT improved significantly from a baseline of 417.8 μm at week 52 (mean change -60.9 μm; p<0.001). Outcomes were similar in eyes switched to DEX early and late. No unexpected adverse events were reported; no filtration surgeries were required.

conclusionTo date, AUSSIEDEX is the largest prospective, real-world study of DEX monotherapy for treatment-naïve or anti-VEGF-refractory DME. Following early or late switch from anti-VEGF agents, DEX significantly improved anatomic outcomes at 52 weeks without new safety concerns, supporting use in anti-VEGF-refractory DME. TRIAL REGISTRATION NUMBER: NCT02731911.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaDexamethasoneDrug ImplantsGlucocorticoidsHumansIntravitreal InjectionsProspective StudiesVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsDexamethasoneDrug ImplantsGlucocorticoidsVascular Endothelial Growth Factor AVascular Endothelial Growth FactorsInflammationMaculaRetinaTreatment MedicalVision

Identifiers

PMID37541745
PMCPMC10407411
OpenAlexW4385575343

What OpenQuestion holds

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LicenceCC BY-NC
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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.