Evidence map›Paper›PMID 36653595›Full record

ArticleEye (London, England)2023

Evaluation of standard-of-care intravitreal aflibercept treatment practices in patients with diabetic macular oedema in the UK: DRAKO study outcomes.

Sobha Sivaprasad, Faruque Ghanchi, Simon P Kelly, Ajay Kotagiri, James Talks, Peter Scanlon, Hellen McGoey, Andrew Nolan, Moneeb Saddiq, Jackie Napier and 1 more

Registry-linked trialOpen access · hybridAbstract readComment
In one paragraph

Article in Eye (London, England), 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02850263 (An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact, top 99% 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.

NCT02850263 completednot on this map

An Observational Study to Assess the Effectiveness of Intravitreal Aflibercept in Routine Clinical Practice tn Patients With Visual Impairment Due to Diabetic Macular Oedema (DMO)

TypeobservationalSponsorBayerRan2016 to 2020Enrolled750ConditionsMacular EdemaArmsEylea (Aflibercept, VEGF Trap-Eye, BAY86-5321), Anti-VEGF therapies including: Eylea Aflibercept, VEGF Trap-Eye, BAY86-5321) and Ophthalmologicals / Antineovascularisation agents (S01LA05)
3 · Its place in the literature

Who cites it

0 citing papers in PubMed, 0 citations in OpenAlex.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

11 authors at 8 institutions in 1 country.

Sobha SivaprasadNational Institute for Health Research, Moorfields Biomedical Research Centre, London, UK. s.sivaprasad@ucl.ac.uk.ORCID 0000-0001-8952-0659
Faruque GhanchiBradford Teaching Hospitals NHS Foundation Trust, Bradford, UK.ORCID 0000-0002-4448-8162
Simon P KellyBolton Hospital NHS Foundation Trust, Bolton, UK.
Ajay KotagiriSouth Tyneside and Sunderland NHS Foundation Trust, Sunderland, UK.
James TalksNewcastle Upon Tyne Hospitals NHS Foundation Trust, Newcastle Upon Tyne, UK.
Peter ScanlonGloucestershire Hospitals NHS Foundation Trust, Cheltenham, UK.ORCID 0000-0001-8513-710X
Hellen McGoeyBayer Plc, Reading, UK.ORCID 0000-0002-9579-9390
Andrew NolanIpsen UK Ltd, Slough, UK.ORCID 0000-0003-0799-2914
Moneeb SaddiqO4 Research Limited, Belfast, UK.
Jackie NapierBayer Plc, Reading, UK.
Peter Morgan-WarrenBayer Plc, Reading, UK.
Bayer (United Kingdom) · GBBolton NHS Foundation Trust · GBBradford Teaching Hospitals NHS Foundation Trust · GBGloucestershire Hospitals NHS Foundation Trust · GBIpsen (United Kingdom) · GBNational Institute for Health Research · GBNewcastle upon Tyne Hospitals NHS Foundation Trust · GBSouth Tyneside and Sunderland NHS Foundation Trust · GB

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

BACKGROUND/

objectivesDRAKO (NCT02850263) was a 24-month, prospective, non-interventional, multi-centre cohort study enrolling patients with diabetic macular oedema (DMO) including central involvement. The study evaluated UK standard-of-care intravitreal aflibercept (IVT-AFL) treatment. This analysis describes the treatment pathway and service provision for the anti-vascular endothelial growth factor (VEGF) treatment-naïve (C1) and non-naïve patients (C2) who received prior anti-VEGF treatment for DMO other than IVT-AFL.

methodsMean changes in best-corrected visual acuity and central subfield thickness were measured and stratified by baseline factors, including ethnicity and administration of five initial monthly injections within predefined windows. Clinic visits were classified as treatment only (T1), monitoring assessment only (T2), combined visits (T3) or post-injection visits with no treatment or assessment (T4).

resultsMedian time from decision to treat to treatment was 6 days. As a percentage of total visits, T1, T2, T3 and T4 were 7%, 42%, 48% and 3% for C1 and 11%, 39%, 48% and 2% for C2. Most IVT-AFL injections were administered by healthcare professionals (HCPs) other than doctors (C1, 57.4%; C2, 58.5%). The percentage of treatments associated with a procedure-related adverse event where at least 75% of injections were completed by the same injector role were similar for doctors and other HCPs (C1, 1.1% and 0.8%; C2, 0.7%, and 1.0%).

conclusionsResults indicate that upon DMO diagnosis, patients were treated promptly, and most visits were combined (treatment and assessment) or monitoring only. Most IVT-AFL was administered by non-physicians with a similar treatment-related safety profile as IVT-AFL administered by physicians.

Indexed as

Diabetes MellitusDiabetic RetinopathyMacular EdemaAngiogenesis InhibitorsCohort StudiesHumansIntravitreal InjectionsProspective StudiesReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsUnited KingdomafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion Proteins

Identifiers

PMID36653595
PMCPMC10397211
OpenAlexW4317212760

What Socratic holds

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LicenceCC BY
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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 Socratic graph.