Evidence map›Paper›PMID 26493038›Full record

Trial reportEye (London, England)2015

A randomized clinical trial comparing fixed vs pro-re-nata dosing of Ozurdex in refractory diabetic macular oedema (OZDRY study).

J Ramu, Y Yang, G Menon, C Bailey, N Narendran, C Bunce, A Quartilho, A T Prevost, P Hykin, S Sivaprasad and 1 more

Open access · bronzeAbstract readComparative StudyMulticenter StudyRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Eye (London, England), 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 17 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
17citing papers in PubMed, 4 pooled it
5.1field-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

17 citing papers in PubMed, 4 syntheses or guidelines pooled it, 37 citations in OpenAlex.

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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 5 institutions in 1 country.

J RamuNIHR Moorfields Biomedical Research Centre, London, UK.
Y YangThe Royal Wolverhampton NHS Trust, Birmingham, UK.
G MenonFrimley Health NHS Foundation Trust, Surrey, UK.
C BaileyBristol Eye Hospital, Bristol, UK.
N NarendranThe Royal Wolverhampton NHS Trust, Birmingham, UK.
C BunceNIHR Moorfields Biomedical Research Centre, London, UK.
A QuartilhoNIHR Moorfields Biomedical Research Centre, London, UK.
A T PrevostDivision of Health and Social Care Research, King's College London London, UK.
P HykinNIHR Moorfields Biomedical Research Centre, London, UK.
S SivaprasadNIHR Moorfields Biomedical Research Centre, London, UK.
OZDRY Study Group
NIHR Moorfields Biomedical Research Centre · GBFrimley Health NHS Foundation Trust · GBBristol Eye Hospital · GBDepartment of Health and Social Care · GBKing's College London · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo compare the clinical effectiveness and safety of 5-monthly fixed dosing vs pro-re-nata (PRN) Ozurdex treatment in patients with refractory diabetic macular oedema (DMO).

designProspective, multicentre, randomized active-controlled non-inferiority clinical trial.

participantsParticipants were 100 patients who attended Medical Retina Clinics for management of centre-involving refractory DMO.

interventionsParticipants were randomized 1 : 1 to either 5-monthly fixed dosing or optical coherence tomography (OCT)-guided PRN regimen of Ozurdex therapy for DMO. Data were collected on best-corrected visual acuity (BCVA), patient-reported outcome measures (PROM), macular thickness and morphology, diabetic retinopathy status, number of injections and adverse events from baseline for a period of 12 months.Main outcome measuresThe primary outcome was the difference between arms in change in BCVA from baseline to 12 months. The prespecified non-inferiority margin was five ETDRS letters. Key secondary outcomes included change in PROM scores, change in macular thickness, change in retinopathy and macular morphology, and safety profile.

resultsThe mean change in BCVA was +1.48 (SD 14.8) in the fixed arm vs -0.17 (SD 13.1) in the PRN arm, with adjusted effect estimate +0.97, 90% confidence interval (-4.01, +5.95), P=0.02 (per protocol analysis). The conclusions of the ITT analysis were primarily supportive, -0.34 (-5.49, 4.81) P=0.07, but sensitive to an alternative assumption on missing data, +0.28 (-4.72, 5.27) P=0.04.

conclusionsThe mean change in BCVA with 5-monthly fixed dosing of Ozurdex was non-inferior to OCT-guided PRN Ozurdex therapy for refractory DMO based on a per protocol analysis.

Indexed as

AgedDexamethasoneDiabetes Mellitus, Type 1Diabetes Mellitus, Type 2Diabetic RetinopathyDrug ImplantsFemaleGlucocorticoidsHumansIntravitreal InjectionsMacular EdemaMaleMiddle AgedProspective StudiesRetinaRetreatmentDexamethasoneDrug ImplantsGlucocorticoids

Identifiers

PMID26493038
PMCPMC5129797
OpenAlexW2143429362

What OpenQuestion holds

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Registered trials

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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.