Miniburst Laser for Early Age-Related Macular Degeneration (MBEAD)v1.0
Research type
Research Study
Full title
A single-centre, prospective randomised pilot study into the safety and efficacy of miniburst laser intervention in early high-risk age-related macular degeneration (MBEAD)
IRAS ID
231388
Contact name
Martin Harris
Contact email
Sponsor organisation
Royal Free London NHS Foundation Trust
Duration of Study in the UK
1 years, 6 months, 2 days
Research summary
The Miniburst Laser for Early Age-Related Degeneration (MBEAD) study is a two-arm parallel, randomised, double-masked, controlled prospective pilot study designed to further investigate the safety and efficacy of miniburst laser intervention as a treatment for patients with early high-risk (advanced intermediate) age-related macular degeneration (AMD). AMD is currently the leading cause of blindness in person aged over 50 years in developed countries. Whilst there is available treatment (i.e. intravitreal anti-VEGF injections) for the wet form of AMD which accounts for the majority of blind registration from this disease, there is still no cure for the disease. Prevention is therefore the first approach to reducing vision loss and the associated burden of AMD. A promising approach to this is the use of miniburst mode laser treatment which have been suggested to bring about changes in the pathology of early AMD (i.e. drusen which accumulate as deposits in the retina).
This study will be a Phase I/IIa pilot study conducted at hospitals under the Royal Free London NHS Foundation Trust in London, UK. The planned enrolment period is 6 months and the planned duration of the study is 18 months (12 months follow-up). The study population will be 36 patients aged 50 to 95 years with early high-risk AMD. The study design is a patient and assessor masked, randomised controlled trial of 36 participants (2:1 active to sham laser procedure) designed to assess the effectiveness of miniburst laser therapy of patients with advanced intermediate AMD. Miniburst laser will be performed in the study eye(s) and each patient will be followed for progression to advanced AMD over a period of one year. The primary study objective is to ascertain whether miniburst laser therapy can reduce drusen area and drusen load as compared with baseline and sham-treated patients.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/2061
Date of REC Opinion
14 Jan 2019
REC opinion
Further Information Favourable Opinion