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 |
| Protocol serial number | MRC ref: G9404235 |
| Sponsor | Medical Research Council (UK) |
| Funder | Medical Research Council (UK) (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
Plain English summary of protocol
Not provided at time of registration
Contact information
Scientific
Department of Ophthalmology
Queen's University of Belfast
Royal Victoria Hospital
Belfast
BT12 6BA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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]) |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/1998 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | All |
| Target sample size at registration | 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
- United Kingdom
- Northern Ireland
Study participating centre
BT12 6BA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
