Contact information
Type
Scientific
Primary contact
Mr NHV Chong
ORCID ID
Contact details
Denmark Hill
Camberwell
London
SE5 9RS
United Kingdom
+44 020 7737 4548
victor@eretina.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0116169807
Study information
Scientific title
Diffuse laser treatment for prophylaxis of the fellow eye with age-related maculopathy in patients with exudative age-related macular degeneration (AMD)
Acronym
Study hypothesis
Age-related macular degeneration (AMD) is the leading cause of blindness in the developed world. The formation of abnormal blood vessels (Choroidal Neovascular Vessels = CNV) under the retina is the main cause of visual loss. It is often referred to as 'wet' AMD. Once the first eye is affected, the other eye has a high risk of developing the disease. This risk is increased (>70% in 5 years) if the fellow eye has signs of early disease in the form of yellow deposits known as drusen.
Drusen disappear in over 60% of eyes treated with focal laser treatment. However, this type of laser can cause focal damage to the eye leading to a slight increase risk of developing CNV. Nonetheless, those who do not develop this complication, have better vision.
We propose to use diffuse laser treatment to make drusen disappear, in which laser energy is transmitted to a larger area of the retina. As the laser energy is applied diffusely, it is unlikely to cause focal damage and hence it is possible that this can reduce the risk of developing CNV. Diffuse laser is has previously been used as a treatment for wet AMD, and it has been shown to be a safe procedure.
The aim of this study is to evaluate whether diffuse laser treatment reduce the rate of CNV development in the fellow eye of patients with wet AMD and hence maintain stable vision.
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
Prevention
Patient information sheet
Condition
Eye Diseases: Age-related macular degeneration (AMD)
Intervention
Age-related macular degeneration (AMD) is one of the leading causes of blindness in the western world. Currently there is no cure for this disease and treatment options for stabilising the vision are limited and expensive.
AMD can be identified in its early stages by the appearance of pigment changes and yellow deposits (drusen) which form in the macular. At this stage the patient usually has minimal symptoms. There is however a high risk of CNV formation which is the blinding condition. We would like to enrol patients at the early stage of the disease to see if our proposed treatment will reduce their risk of converting to CNV.
Eligible patients will be referred to the principle investigator for the project who will explain the aims and limitations of the study including the background data, study design and relevant risks and benefits. Written informed consent will be obtained and a patient information leaflet including contact numbers will be given to the patient. A letter explaining the details and enrolment into the trial will be sent to the GP.
Patients will be asked to attend the outpatient clinic on day 1 (baseline) with follow up at 6 monthly intervals for the first year and yearly for the second year.
The baseline visit will include documentation of visual acuity, complete ocular examination, colour fundus photography, taking a single serum sample for analysis followed by randomisation to either diffuse laser treatment or placebo treatment of the fellow eye.
The diffuse laser treatment or placebo will involve instillation of topical anaesthetic drops followed by placing a laser contact lens on the eye to be treated. A diode laser using 3000 micron spot size at 400mW (active treatment) or 0mW (placebo) is applied for 60 seconds centred on the fovea. No after care is required.
Follow up appointments will be carried out by a masked observer with repeat documentation of the visual acuity, colour fundus photography. Repeat serum sample is taken at exit from the trial. All visual symptoms are documented and a complete dilated ocular examination will be performed.
The rate of conversion to CNV will be documented and confirmed using fundus fluoresceine angiogram.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Rate of development of CNV
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/07/2005
Overall trial end date
01/01/2009
Reason abandoned
Eligibility
Participant inclusion criteria
Outpatients aged 55 or over with a diagnosis of exudative age-related macular degeneration in one eye and early changes of AMD (drusen and retinal pigment changes) in the other eye
Participant type
Patient
Age group
Senior
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Patients in whom colour fundus photography is not possible due to ocular media opacities or other disabilities
2. Those with other retinal diseases.
Recruitment start date
01/07/2005
Recruitment end date
01/01/2009
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Denmark Hill
London
SE5 9RS
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Kings College Hospital NHS Trust R&D Consortium
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Own Account
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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