A pilot RCT of ranibizumab in diabetic vitrectomy - The RaDiVit Study

• Research type

  Research Study

• Full title

  A prospective, randomised controlled trial of Ranibizumab pre-treatment in Diabetic Vitrectomy – a pilot study.

• IRAS ID

  62924

• Contact name

  James Bainbridge

• Sponsor organisation

  Moorfields Eye Hospital

• Eudract number

  2010-024062-22

• ISRCTN Number

  ISRCTN

• Research summary

  People with diabetes commonly have problems with their eyes because diabetes affects the way blood vessels function. The retina is the light-sensitive surface inside the eye and when diabetes affects blood vessels in the retina, patients are said to have diabetic retinopathy. Sometimes, fragile new blood vessels that bleed easily and cause scarring can grow - this is proliferative diabetic retinopathy.Proliferative diabetic retinopathy is the severest form of diabetic eye disease and is a leading cause of blindness in the working-age population. In the early stages of proliferative diabetic retinopathy laser treatment can help to reverse some of the changes. Despite having this laser treatment, some patients with this condition need surgery to clear blood from inside the eye and to cut away fibrous scar tissue that has grown onto the retina, worsening vision. This is called vitrectomy surgery.Even with this surgery, there is sometimes more bleeding and patients don't always see very well afterwards.This project will investigate whether the injection into the eye of a drug, ranibizumab, helps to shrink blood vessels and improve the vision for patients having this operation. This drug has been used in many thousands of patients to treat a different eye condition called age-related macular degeneration, so is known to be very safe.This trial, sponsored by Moorfields Eye Hospital in collaboration with Novartis, will recruit 30 patients undergoing vitrectomy surgery at Moorfields Eye Hospital. Every participant will have their vision tested and have scans and photographs taken of their eyes. Half will receive a ranibizumab injection one week before surgery and half will receive saline. We will evaluate the success of the surgery by repeating these tests at six weeks after surgery and again at twelve weeks, which marks the end of the trial.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/H0718/5

• Date of REC Opinion

  22 Mar 2011

• REC opinion

  Further Information Favourable Opinion