Intravitreal Macugen for Ischaemic Diabetic Macular Oedema

• Research type

  Research Study

• Full title

  A Phase IV Open-Labelled Prospective Pilot Study of Intravitreal Macugen (pegaptanib) for Ischaemic Diabetic Macular Oedema (MIDME study)

• IRAS ID

  34342

• Contact name

  Victor Chong

• Sponsor organisation

  Clinical Trials and Research Governance

• Eudract number

  2009-017540-13

• ISRCTN Number

  not known

• Research summary

  Diabetic macular oedema (DME) is the leading cause of blindness in the UK??s working population. It affects the macula, which lies at the centre of the retina, at the back of the eye. Damage to the macula can occur either because the blood supply is reduced (ischaemic DME), or because the blood vessels are leaking excessively (exudative DME). A chemical called vascular endothelial growth factor (VEGF) may underlie some of the abnormalities seen in DME. Studies have shown that VEGF encourages leakage oflud from blood vessels and increases the stickiness of white blood cells. When white blood cells are sticky they can attach to blood vessel walls. This may cause small blood vessels to block, and lead to ischaemia. Laser treatment often helps to stabilise exudative DME, but there is currently no recognised treatment for ischaemic DME. Macugen (pegaptanib), a drug that inactivates VEGF, has been tried and found to be of benefit in treating exudative DME. Since VEGF promotes ischaemia, it is possible that Macugen will also prove to be beneficial for ischaemic DME. This has not been tested before. A healthy macula is essential for good vision. The innermost area of the macula, the foveal avascular zone (FAZ), is the most important part. The FAZ is enlarged when it is ischaemic. This is a pilot study to assess whether Macugen can reduce the size of the FAZ in ischaemic DME. We will also assess whether it can reduce retinal thickness and improve vision in ischaemic DME. Thirty patients will be involved in the study for thirty weeks each. They will have their eyes examined and receive an injection of Macugen into the eye every 6 weeks. The study is taking place in the Oxford Eye Hospital and is being funded by Pfizer, the company that makes Macugen.

• REC name

  London - West London & GTAC Research Ethics Committee

• REC reference

  10/H0803/58

• Date of REC Opinion

  12 Jul 2010

• REC opinion

  Further Information Favourable Opinion