OCTOME Study

• Research type

  Research Study

• Full title

  An exploratory phase III prospective open-label clinical study on monthly OCT monitoring of the effects of Ozurdex for macular oedema related to retinal vascular diseases

• IRAS ID

  65597

• Contact name

  Sobha Sivaprasad

• Sponsor organisation

  King's College Hospital NHS Foundation Trust

• Eudract number

  2010-023110-30

• ISRCTN Number

  ISRCTN

• Research summary

  Ozurdex, a long acting dexamethasone intravitreal injection, has recently received approval both in USA and Europe for use in macular oedema secondary to retinal vein occlusions. This was based on a clinial trial that treated the patients every 6 months. However, the effect of the drug was shown to fade off at about 4 months. The reason for this effect could not be ascertained as OCT (optical coherence tomography) was not done monthly to assess treatment response. So in this study, we aim to monitor these patients every month to assess response and treat the patient at any point after 4 months if the visual acuity declines and there is eveidence of rebound oedema on OCT. This will ensure that each patient get maximum benefit based on individual treatment response with close monitoring of safety events.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/H0718/6

• Date of REC Opinion

  11 Apr 2011

• REC opinion

  Further Information Favourable Opinion