Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
MRC ref: G9404235
Study information
Scientific title
Acronym
SFRADS
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Subfoveal neovascular membranes
Intervention
Radiotherapy at a total dose of 12 Gy versus control
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/1995
Overall trial end date
01/12/1998
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Target population aged 60 years or over, with subfoveal CNVM and diagnosis of ARMD confirmed by the clinical and angiographic examination
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
240
Participant 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.
Recruitment start date
01/12/1995
Recruitment end date
01/12/1998
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Department of Ophthalmology
Belfast
BT12 6BA
United Kingdom
Sponsor information
Organisation
Medical Research Council (UK)
Sponsor details
20 Park Crescent
London
W1B 1AL
United Kingdom
+44 (0)20 7636 5422
clinical.trial@headoffice.mrc.ac.uk
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
Medical Research Council (UK) (ref: G9404235)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12149056
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16024863
Publication citations
-
Results
Stevenson MR, Hart PM, Chakravarthy U, Mackenzie G, Bird AC, Owens SL, Chisholm IH, Hall V, Houston RF, McCulloch DW, Plowman N, Visual functioning and quality of life in the SubFoveal Radiotherapy Study (SFRADS): SFRADS report 2., Br J Ophthalmol, 2005, 89, 8, 1045-1051, doi: 10.1136/bjo.2003.030445.
-
Hart PM, Chakravarthy U, Mackenzie G, Chisholm IH, Bird AC, Stevenson MR, Owens SL, Hall V, Houston RF, McCulloch DW, Plowman N, Visual outcomes in the subfoveal radiotherapy study: a randomized controlled trial of teletherapy for age-related macular degeneration., Arch. Ophthalmol., 2002, 120, 8, 1029-1038.