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Sivaprasad S, Hykin P, Prevost AT, et al. Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT. Southampton (UK): NIHR Journals Library; 2018 Oct. (Efficacy and Mechanism Evaluation, No. 5.5.)

Cover of Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT

Intravitreal aflibercept compared with panretinal photocoagulation for proliferative diabetic retinopathy: the CLARITY non-inferiority RCT.

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List of abbreviations

ADL

activities of daily living

ANCOVA

analysis of covariance

APTC

Anti-Platelet Triallists’ Collaboration

AUC

area under the curve

AWI

average weighted impact

BCVA

best corrected visual acuity

BNF

British National Formulary

BP

blood pressure

CARF

Central Angiographic Resource Facility

CEAC

cost-effectiveness acceptability curve

CFP

colour fundus photography

CI

confidence interval

CLARITY

clinical efficacy and mechanistic evaluation of aflibercept for proliferative diabetic retinopathy

CONSORT

Consolidated Standards of Reporting Trials

CSRI

client service receipt inventory

CST

central subfield thickness

DD

disc diameter

DMEC

Data Monitoring and Ethics Committee

DMO

diabetic macular oedema

eCRF

electronic case report form

EDC

electronic data capture

EMA

European Medicines Agency

EQ-5D-3L

EuroQol-5 Dimensions, three-level version

ETDRS

Early Treatment Diabetic Retinopathy Study

EudraCT

European Union Drug Regulating Authorities Clinical Trials

FA

fluorescein angiography

FDA

US Food and Drug Administration

FFA

fundus fluorescein angiography

HbA1c

glycated haemoglobin

HRQoL

health-related quality of life

ICECAP-A

Investigating Choice Experiments Capability Measure for Adults

ICER

incremental cost-effectiveness ratio

ICH

International Conference on Harmonisation

IMP

investigational medicinal product

IQR

interquartile range

ITT

intention to treat

KCTU

King’s Clinical Trials Unit

LME

linear mixed-effects

MAR

missing at random

MHRA

Medicines and Healthcare products Regulatory Agency

mRNA

messenger ribonucleic acid

NEI-VFQ-25

National Eye Institute Visual Function Questionnaire

NetwORC UK

Network of Ophthalmic Reading Centres UK

NICE

National Institute for Health and Care Excellence

NIHR

National Institute for Health Research

NV

neovascularisation

NVA

neovascularisation of the angle

NVG

neovascular glaucoma

NVI

neovascularisation of iris

OBE

Officer of the Most Excellent Order of the British Empire

OCT

optical coherence tomography

PAS

Patient Access Scheme

PDR

proliferative diabetic retinopathy

PIN

patient identification number

PP

per protocol

PRP

panretinal photocoagulation

QALY

quality-adjusted life-year

RCT

randomised controlled trial

RetDQoL

Retinopathy-Dependent Quality-of-Life Questionnaire

RetTSQ

Retinopathy Treatment Satisfaction Questionnaire

SAE

serious adverse event

SD

standard deviation

SD-OCT

spectral-domain optical coherence tomography

SE

standard error

SOP

standard operating procedure

TMG

Trial Management Group

TSC

Trial Steering Committee

VEGF

vascular endothelial growth factor

Copyright © Queen’s Printer and Controller of HMSO 2018. This work was produced by Sivaprasad et al. under the terms of a commissioning contract issued by the Secretary of State for Health and Social Care. This issue may be freely reproduced for the purposes of private research and study and extracts (or indeed, the full report) may be included in professional journals provided that suitable acknowledgement is made and the reproduction is not associated with any form of advertising. Applications for commercial reproduction should be addressed to: NIHR Journals Library, National Institute for Health Research, Evaluation, Trials and Studies Coordinating Centre, Alpha House, University of Southampton Science Park, Southampton SO16 7NS, UK.
Bookshelf ID: NBK531676

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