Condition category
Eye Diseases
Date applied
17/10/2000
Date assigned
17/10/2000
Last edited
26/03/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Professor Usha Chakravarthy

ORCID ID

Contact details

Department of Ophthalmology
Queen's University of Belfast
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom

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 measures

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

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

http://www.mrc.ac.uk

Funders

Funder type

Research council

Funder name

Medical Research Council (UK) (ref: G9404235)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

Results - basic reporting

Publication summary

2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12149056
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/16024863

Publication citations

  1. 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.

  2. 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.

Additional files

Editorial Notes