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ISRCTN
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ISRCTN84737434
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DOI
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10.1186/ISRCTN84737434
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Radiotherapy in the treatment of subfoveal neovascular membranes (CNVM) in age-related macular degeneration (ARMD) of the eye: a randomised controlled trial
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Scientific title
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Acronym
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SFRADS
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Serial number at source
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MRC ref: G9404235
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Study hypothesis
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To determine if radiotherapy has a treatment benefit in CNVM at a total dose of 12 Gy. To monitor for any adverse side-effects attributable to radiotherapy. To assess quality of life improvements attributable to therapy using a package of instruments which will be validated during the course of the study. To carry out an economic assessment by establishing the cost of treatment and any offsetting savings to the health and personal; social services associated with treatment.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Subfoveal neovascular membranes
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Participants - inclusion criteria
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Target population aged 60 years or over, with subfoveal CNVM and diagnosis of ARMD confirmed by the clinical and angiographic examination
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Participants - exclusion criteria
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1. Patients under 60 years of age
2. Those with vision worse than Bailey Lovie 1.0
3. Patients not wishing to be included in the study
4. Patients with unstable hypertension, diabetes or generalised vasculitides and or life-threatening disorder making three year survival unlikely.
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Anticipated start date
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01/12/1995
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Anticipated end date
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01/12/1998
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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240
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Interventions
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Radiotherapy at a total dose of 12 Gy versus control
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Primary outcome measure(s)
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1. Efficacy: distance visual acuity (ETDRS), near visual acuity (ETDRS), contrast sensitivity (Pelli Robson), reading speed, ophthalmoscopy, slit-lamp biomicroscopy, fundus photography, fluorescein angiography, generic quality of life questionnaire, condition-specific quality of life questionnaire, assessment of tear film, lens clarity, retinal vasculature and (electrophysiology to monitor retinal and optic nerve function [Belfast only])
2. Health economics: evaluation of treatment costs, care costs, costs on patient and family
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (UK) (ref: G9404235)
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Trial website
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Publications
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2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12149056
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16024863
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Contact name
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Professor
Usha
Chakravarthy
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Address
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Department of Ophthalmology
Queen's University of Belfast
Royal Victoria Hospital
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City/town
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Belfast
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Zip/Postcode
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BT12 6BA
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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17/10/2000
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Last edited
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26/03/2009
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Date ISRCTN assigned
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17/10/2000
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