Evidence map›Paper›PMID 26369798›Full record

Trial reportBMJ open2015

Clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy (acronym CLARITY): a multicentre phase IIb randomised active-controlled clinical trial.

Sobha Sivaprasad, A Toby Prevost, James Bainbridge, Rhiannon Tudor Edwards, David Hopkins, Joanna Kelly, Phil Luthert, Caroline Murphy, Jayashree Ramu, Negin Sarafraz-Shekary and 3 more

Open access · goldAbstract readClinical Trial, Phase IIMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMJ open, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 1 pooled it
1.4field-weighted citation impact, top 18% 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

12 citing papers in PubMed, 1 synthesis or guideline pooled it, 27 citations in OpenAlex.

  1. Pooled it
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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

13 authors at 5 institutions in 1 country.

Sobha SivaprasadNIHR Moorfields Biomedical Research Centre, London, UK.
A Toby PrevostKCL Department of Primary Care and Public Health Sciences, NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust, and King's College London, London, UK.
James BainbridgeNIHR Moorfields Biomedical Research Centre, London, Institute of Ophthalmology, London, UK.
Rhiannon Tudor EdwardsCentre for Health Economics and Medicines Evaluation, Bangor University, Bangor, Gwynedd, UK.
David HopkinsDepartment of Diabetes and Endocrinology, King's College Hospital NHS Foundation Trust, London, UK.
Joanna KellyKing's Clinical Trials Unit at KHP, Kings College London, Institute of Psychiatry, London, UK.
Phil LuthertInstitute of Ophthalmology, London, UK.
Caroline MurphyKing's Clinical Trials Unit at KHP, Kings College London, Institute of Psychiatry, London, UK.
Jayashree RamuNIHR Moorfields Biomedical Research Centre, London, UK.
Negin Sarafraz-ShekaryKing's Clinical Trials Unit at KHP, Kings College London, Institute of Psychiatry, London, UK.
Joana VasconcelosKCL Department of Primary Care and Public Health Sciences, NIHR Biomedical Research Centre at Guy's and St Thomas' NHS Foundation Trust, and King's College London, London, UK.
Beverley White-AlaoKing's Clinical Trials Unit at KHP, Kings College London, Institute of Psychiatry, London, UK.
Philip HykinNIHR Moorfields Biomedical Research Centre, London, UK.
King's College London · GBNIHR Moorfields Biomedical Research Centre · GBBangor University · GBGuy's and St Thomas' NHS Foundation Trust · GBKing's College Hospital NHS Foundation Trust · GB

Funding

Department of Health 12/66/15Department of Health NIHR-RP-011-003Medical Research Council EME 12/66/15
6 · The paper itself

Abstract

introductionProliferative diabetic retinopathy (PDR) is the main cause of severe visual loss in people with diabetes mellitus. The standard treatment for this condition is panretinal photocoagulation (PRP). This laser treatment is inherently destructive, with predictable adverse effects on visual function, and a safer alternative is required. Intravitreal injection of vascular endothelial growth factor (VEGF) inhibitors can induce short-term regression of retinal neovascularisation. The aim of this randomised controlled trial is to determine the efficacy, safety and cost-effectiveness of intravitreal aflibercept, an inhibitor of VEGF-A, VEGF-B and placental growth factor (PLGF), in PDR, and to investigate the impact on local oxygenation. METHODS AND ANALYSIS: This is a phase IIb randomised controlled single-masked multicentre clinical trial to determine the impact of repeated intravitreal aflibercept injections in the treatment and prevention of PDR. 220 participants with treatment-naïve or treated but active retinal neovascularisation in at least one eye will be randomly allocated 1:1 to intravitreal aflibercept injections or PRP for a period of 52 weeks. The primary outcome is the change in best-corrected visual acuity in the study eye at 52 weeks. Secondary outcomes include changes from baseline in other visual functions, anatomical changes and cost-effectiveness. Ocular and non-ocular adverse events will also be reported over 52 weeks. ETHICS AND DISSEMINATION: The study has been approved by the National Research Ethics Service (NRES) committee with respect to scientific content and compliance with applicable research and human subjects' regulations. Findings will be reported through scientific publications and research conferences. The results of this study will provide clinical evidence for the feasibility, efficacy safety and cost-effectiveness of intravitreal aflibercept for PDR. TRIAL REGISTRATION NUMBER: ISRCTN 32207582.

Indexed as

Angiogenesis InhibitorsDiabetic RetinopathyFemaleHumansIntravitreal InjectionsMaleReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsTreatment OutcomeVascular Endothelial Growth Factor AVisual AcuityafliberceptAngiogenesis InhibitorsReceptors, Vascular Endothelial Growth FactorRecombinant Fusion ProteinsVascular Endothelial Growth Factor AVEGFA protein, human

Identifiers

PMID26369798
PMCPMC4577925
OpenAlexW2276823644

What OpenQuestion holds

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LicenceCC BY
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Registered trials

None linked

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.