Vitrectomy In Diabetic macular Oedema Trial (VIDEO Trial)
Research type
Research Study
Full title
The VIDEO Trial: A Feasibility Randomised Control Trial of Vitrectomy Plus Standard Care Intravitreal Ranibizumab Injections versus Standard Care Intravitreal Ranibizumab injections Alone In Patients With Centre Involving Diabetic Macular Edema
IRAS ID
220073
Contact name
DAH Laidlaw
Contact email
Sponsor organisation
Kings College London
Duration of Study in the UK
2 years, 0 months, 0 days
Research summary
Diabetic macular edema (DME) is the commonest cause of sight loss in working age adults.
Treatments of DME aim to improve vision by reducing macular swelling.
Standard NICE approved treatment since 2011 has been with injections into the eye of anti VEGF drugs such as Ranibizumab or Aflibercept. These agents are effective in improving vision but 9 injections are required in the first year and up to six in the second. The treatment is also not universally effective. These injections impose a considerable cost and time burden on patients and the NHS. The introduction of anti-VEGF agents has been a paradigmn shift; prior to this macular laser was the standard of care which reduced the rate of vision loss rather than improving vision.
Vitrectomy is surgery to remove the jelly-like substance inside the eye and from the surface of the retina. Most studies indicate that vitrectomy for DME results in lasting improvements in macular swelling.When there is a membrane distorting the surface of the macula the surgery has also been shown to improve vision, this is about ¼ of patients with DME who may anyway be less responsive to drug therapy. In the absence of such a membrane the visual benefit is less clear. Such surgery was usually performed as rescue treatment when repeated laser had failed and the retina was damaged. Where vitrectomy has been performed early vision has improved.
Our aim is to investigate whether adding a vitrectomy to the standard injection treatment of DME improves treatment outcomes measured in terms of vision, macular swelling and number of injections. We propose a randomised feasibility trial of 100 patients stratified on the basis of macular traction. This initial trial is to inform the design of a larger definitive trial and is not expected to provide definitive proof of effectiveness.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/0324
Date of REC Opinion
10 Apr 2018
REC opinion
Further Information Favourable Opinion