Radiotherapy in the treatment of subfoveal neovascular membranes (CNVM) in age-related macular degeneration (ARMD) of the eye: a randomised controlled trial

ISRCTN ISRCTN84737434
DOI https://doi.org/10.1186/ISRCTN84737434
Secondary identifying numbers MRC ref: G9404235
Submission date
17/10/2000
Registration date
17/10/2000
Last edited
26/03/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Eye Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Usha Chakravarthy
Scientific

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study acronymSFRADS
Study objectivesTo 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSubfoveal neovascular membranes
InterventionRadiotherapy at a total dose of 12 Gy versus control
Intervention typeOther
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/12/1995
Completion date01/12/1998

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target number of participants240
Key inclusion criteriaTarget population aged 60 years or over, with subfoveal CNVM and diagnosis of ARMD confirmed by the clinical and angiographic examination
Key exclusion criteria1. 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.
Date of first enrolment01/12/1995
Date of final enrolment01/12/1998

Locations

Countries of recruitment

  • Northern Ireland
  • United Kingdom

Study participating centre

Department of Ophthalmology
Belfast
BT12 6BA
United Kingdom

Sponsor information

Funders

Funder type

Research council

Medical Research Council (UK) (ref: G9404235)
Government organisation / National government
Alternative name(s)
Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location
United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/2002 Yes No
Results article results 01/08/2005 Yes No
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