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
Professor Usha Chakravarthy
Scientific
Scientific
Department of Ophthalmology
Queen's University of Belfast
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study acronym | SFRADS |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Subfoveal neovascular membranes |
| Intervention | Radiotherapy at a total dose of 12 Gy versus control |
| Intervention type | Other |
| 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 study start date | 01/12/1995 |
| Completion date | 01/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | 240 |
| Key inclusion criteria | Target population aged 60 years or over, with subfoveal CNVM and diagnosis of ARMD confirmed by the clinical and angiographic examination |
| Key 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. |
| Date of first enrolment | 01/12/1995 |
| Date of final enrolment | 01/12/1998 |
Locations
Countries of recruitment
- Northern Ireland
- United Kingdom
Study participating centre
Department of Ophthalmology
Belfast
BT12 6BA
United Kingdom
BT12 6BA
United Kingdom
Sponsor information
Medical Research Council (UK)
Research council
Research council
20 Park Crescent
London
W1B 1AL
United Kingdom
| Phone | +44 (0)20 7636 5422 |
|---|---|
| clinical.trial@headoffice.mrc.ac.uk | |
| Website | http://www.mrc.ac.uk |
Funders
Funder type
Research council
Medical Research Council (UK) (ref: G9404235)
Government organisation / National government
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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not 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 |
