Intravitreal Macugen for Ischaemic Diabetic Macular Oedema (MIDME)
Diabetic macular oedema (DME) is one of the leading causes of blindness in the United Kingdom'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 of fluid 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. The investigators 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.
|Diabetic Macular Oedema||Drug: Intravitreal injection of pegaptanib sodium||Phase 4|
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
|Official Title:||A Phase IV OpenLabelled Prospective Pilot Study of Intravitreal Macugen (Pegaptanib) for Ischaemic Diabetic Macular Oedema (MIDME Study)|
- Change in size of FAZ at 30 weeks [ Time Frame: 30 weeks ]
- Change in central foveal thickness and best corrected visual acuity at 30 weeks. [ Time Frame: 30 weeks ]
|Study Start Date:||January 2011|
|Study Completion Date:||March 2013|
|Primary Completion Date:||March 2013 (Final data collection date for primary outcome measure)|
Participants receiving 6-weekly treatment with pegaptanib sodium (Macugen [TM]) for ischaemic diabetic macular oedema over a 30 week period.
Drug: Intravitreal injection of pegaptanib sodium
Eligible participants with ischaemic diabetic macular oedema will receive an intravitreal injection of pegaptanib sodium (Macugen [TM]) 0.3mg every 6 weeks over a 30 week period.
Other Name: Macugen 0.3mg
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01175070
|Oxford Eye Hospital|
|Oxford, Oxfordshire, United Kingdom, OX3 9DU|
|Principal Investigator:||Victor Chong, MPhil, MD, FRCSEd, FRCOphth||Oxford Eye Hospital|