Ozurdex in PVR

• Research type

  Research Study

• Full title

  Ozurdex in proliferative vitreoretinopathy; a randomised control trial

• IRAS ID

  88688

• Contact name

  David Charteris

• Sponsor organisation

  Moorfields Eye Hospital NHS Foundation Trust

• Eudract number

  2011-004498-96

• ISRCTN Number

  ISRCTN

• Research summary

  The purpose of this study is to investigate the potential benefit of an additional anti-inflammatory treatment (Ozurdex) to improve the outcome of surgery in eyes that have developed scar tissue (proliferative vitreoretinopathy, PVR) on the surface of the retina after it has become detached. The retina is the light-sensitive layer that lines the eye and is necessary for vision. The development of PVR can increase the failure rate of surgically reattaching the retina. The study is designed to investigate whether Ozurdex is a feasible treatment to prevent this scarring response from recurring. The standard treatment involves an operation to reattach the retina and fill the eye with silicone oil (to keep the retina in place). The oil is then removed later as a second operation. We plan to enrol 140 patients and randomly divide them into 2 groups. Both groups will receive the standard surgical procedure needed to reattach the retina as mentioned above. The study treatment group will receive an injection of Ozurdex at the time of their first surgery (and again repeated at the time of their second planned surgery) whereas the control group will not receive any additional treatment. We will perform identical assessments over 12 months (as 9-11 visits to the out- patient department) each taking approximately one hour. The assessments will be standard eye examinations and a scan of the back of the eye, which would routinely be performed as part of normal care. No tests are invasive or painful. We plan to compare the results of the assessments between the two groups to determine whether the additional use of Ozurdex offers any benefit. This study is an NHS sponsored study (Moorfields Eye Hospital NHS Foundation Trust) and commercially funded (Allergan Ltd) trial.

• REC name

  London - Central Research Ethics Committee

• REC reference

  11/LO/1685

• Date of REC Opinion

  25 Nov 2011

• REC opinion

  Further Information Favourable Opinion