Subconjunctival bevacizumab for corneal neovascularization RCT

• Research type

  Research Study

• Full title

  Pilot Randomised Placebo-Controlled Double-Masked Clinical Trial of Subconjunctival Bevacizumab on eyes with recent onset of corneal neovascularization

• IRAS ID

  11948

• Sponsor organisation

  Moorfields Eye Hospital

• Eudract number

  2008-007984-17

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  n/a

• Research summary

  The human cornea is the clear window in front of the eye. Normally it has no blood vessels, which is important to maintain its transparency and focus light for seeing. The growth of new blood vessels where there were none previously is called corneal neovascularisation (CN). CN results in a reduction in the clarity of the cornea, causing a reduction in a patient's vision and often leads to blindness. CN is very common in the community and every year it is estimated that 280,000 patients in the UK develop the condition. The cause of CN is due to a number of different conditions which all damage the cornea. These include excessive contact lens use, corneal infections, chemical injuries, chronic inflammation of the eye. Despite its commonness, there are few treatments to treat CN. The current standard is topical corticosteroids, which are only mildly effective. Recently a medication has been designed called bevacizumab, which is a modified human/mouse antibody that blocks the growth of new blood vessels. It is available through the NHS to treat bowel cancers; however, it has also been shown and used in the NHS to treat blood vessel growth in patients with macular degeneration and appears so far to be safe and effective in preventing blindness in these patients. We have designed a pilot randomised controlled trial to investigate the effectiveness and safety of bevacizumab (Avastin) for CN. The study will give all 30 patients standard therapy of steroid eye drops. In addition, patients will be randomly assigned to receive either monthly bevacizumab injections or a monthly saline (placebo) injection, for a duration of 3 months. Full eye examinations and digital photography will be performed at each monthly visit.This research is sponsored by Moorfields Eye Hospital and funded by the Special Trustees of Moorfields.

• REC name

  London - City & East Research Ethics Committee

• REC reference

  09/H0703/2

• Date of REC Opinion

  2 Mar 2009

• REC opinion

  Further Information Favourable Opinion