Perception Study Version 1.0

• Research type

  Research Study

• Full title

  A PHASE IIIB, ONE YEAR, OPEN LABEL, MULTICENTRE, NONCOMPARATIVE STUDY TO EVALUATE THE SAFETY AND TOLERABILITY OF INTRAVITREAL PEGAPTANIB SODIUM INJECTION IN SUBJECTS WITH DIABETIC MACULAR EDEMA (DME)

• IRAS ID

  67938

• Contact name

  Christopher Brand

• Sponsor organisation

  Pfizer Inc

• Eudract number

  2010-020946-80

• Research summary

  Diabetic macular oedema is swelling of the retina in diabetes due to leaking oflud from blood vessels within the macula. The macula is the central portion of the retina (an inner layer of the eye), a small area rich in the specialised nerve endings that detect colour and upon which daytime vision depends.The drug under research in this study is pegaptanib sodium (Macugen©) and is approved in Europe and US and available by prescription for age-related macular degeneration (AMD). Age related macular degeneration is a medical condition that usually affects older adults, and can result in a loss of vision in the centre of the visual field (the macula) because of damage to the retina. However, the use of pegaptanib sodium in this study to treat diabetic macular edema is investigational. It is investigational because pegaptanib sodium is currently not approved to treat diabetic macular edema. The purpose of this study is to learn about the effects of pegaptanib sodium in treating diabetic macular edema and to learn about any side effects.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  11/H1005/7

• Date of REC Opinion

  1 Mar 2011

• REC opinion

  Further Information Favourable Opinion