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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN84737434 |
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Date of registration:
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17/10/2000 |
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Prospective Registration:
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No |
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Primary sponsor: |
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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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Date of first enrolment:
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01/12/1995 |
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Target sample size:
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240 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN84737434 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Usha
Chakravarthy |
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Address:
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Department of Ophthalmology
Queen's University of Belfast
Royal Victoria Hospital
BT12 6BA
Belfast
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: Target population aged 60 years or over, with subfoveal CNVM and diagnosis of ARMD confirmed by the clinical and angiographic examination
Exclusion criteria: 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.
Age minimum:
Age maximum:
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Subfoveal neovascular membranes
Eye Diseases
Other retinal disorders
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Intervention(s)
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Radiotherapy at a total dose of 12 Gy versus control
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Primary Outcome(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(s)
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Not provided at time of registration
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Secondary ID(s)
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MRC ref: G9404235
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Source(s) of Monetary Support
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Medical Research Council (UK) (ref: G9404235)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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