Manchester anti-VEGF vs anti-VEGF & Laser (MarVEL) Study
Research type
Research Study
Full title
Comparison of Therapeutic Effect of Ranibizumab/Bevacizumab alone with the combination of Ranibizumab/Bevacizumab and Laser Therapy in Fovea-involving Diabetic Macular Oedema: MarVEL (Manchester anti-VEGF vs anti-VEGF & Laser) Study.
IRAS ID
168410
Contact name
Greg Nagy
Contact email
Sponsor organisation
Topcon Corporation
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Diabetic Macular Oedema (DMO) is a major cause of visual impairment in patients with diabetes. Historically, laser photocoagulation was the standard treatment for DMO based on results from previous studies. However, this technique suffers from some adverse events that can still occur, such as loss of central vision, decreased colour vision etc., mostly caused by the progressive enlargement of the laser scars.
Recent developments in laser treatments have managed to minimize the damage on the retina (ie the back of the eye) while maintaining at least similar treatment efficacy. Such a recently developed strategy is Pascal laser photocoagulation, which uses barely visible light to induce minimal laser scar formation while being as effective as the standard laser treatment.
Another treatment of choice that has recently emerged is the use of Anti-Vascular Endothelial Growth (anti-VEGF) factors, such as ranibizumab. Increased VEGF levels in the vitreous of eyes with diabetic retinopathy have been reported therefore making anti-VEGF treatment an attractive therapeutic option in DMO. Previous studies have shown that anti-VEGF treatment, either alone or in combination with conventional laser therapy, is well tolerated and significantly more effective in providing rapid and continuous improvements in visual acuity over 12 months.
The aim of this study is to demonstrate that non-damaging laser treatment (ie Pascal laser) in combination with ranibizumab/bevacizumab (ie anti-VEGF factor) will reduce the treatment burden on both the patient and the health system, compared with ranibizumab/bevacizumab alone.
REC name
North West - Greater Manchester Central Research Ethics Committee
REC reference
16/NW/0306
Date of REC Opinion
24 Jun 2016
REC opinion
Further Information Favourable Opinion