Efficacy of Pegaptanib Sodium in Preproliferative Diabetic Retinopathy

• Research type

  Research Study

• Full title

  Efficacy of Pegaptanib Sodium in Pre-proliferative Diabetic Retinopathy

• Sponsor organisation

  Frimley Park Hospital Foundation NHS Trust

• Eudract number

  2007-006795-10

• ISRCTN Number

  N/A

• Research summary

  Standard treatment option for Pre-proliferative diabetic retinopathy is now only observation and no treatment. When the disease progresses toproliferative diabetic reyinopathy (PDR), the treatment is laser photocoagulation. Pan retinal photocoagulation (PRP), the standard treatment for PDR, reduces risk of severe visual loss by 50%. However, this destructive procedure causes decreased field of vision and difficulties with night vision and often patients have to give up their driving license. As PDR is VEGF(vascular endothelial growth factor) driven, inhibition of VEGF may be an effective preventive option. A retrospective analysis of a phase II clinical trial of Macugen in patients with DME followed up for 36 weeks, demonstrated regression of retinal neovascularisation. The hypothesis for this study is intravitreal Macugen, a specific VEGF-A 165 isomer; given at the stage of severe non-proliferative diabetic retinopathy (sNPDR) should prevent the development of PDR and the need for Pan retinal photocoagulation

• REC name

  London - South East Research Ethics Committee

• REC reference

  08/H1102/91

• Date of REC Opinion

  19 Nov 2008

• REC opinion

  Further Information Favourable Opinion