Brimonidine 190342-031D Retinal Detachment

• Research type

  Research Study

• Full title

  A Multicenter, Masked, Randomized, Sham-Controlled, Parallel-Group, 3 Month, Study with a 9 Month Safety Extension to Evaluate the Safety and Effects on Visual Function of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS) Applicator System in Patients with a Previous Rhegmatogenous Macula-Off Retinal Detachment

• IRAS ID

  32976

• Contact name

  David Charteris

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2009-015586-31

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  NCT00972374

• Research summary

  Rhegmatogenous Retinal Detachment (RRD) is the most common form of retinal detachment and Rhegmatogenous means the detachment is due to a leaking retinal tear, which allowflud to pass underneath the layer of light sensitive cells (neural retina) at the back of the eye, and detaches it from the supporting layer (retinal pigment epithelium) which means they do not function and may degenerate. Myopia (short-sightedness), cataract surgery and trauma are all leading risk factors for the development of RRDs.Surgery is needed to repair the detachment, this provides excellent structural repair of RRD however recovery of vision to pre-RRD levels is not guaranteed and the presence of a macular detachment means a poorer visual improvement. Patients have stable vision 3 to 6 months after surgery; however there are no current treatments for patients with stable vision loss following RRD. This study uses Brimonidine Tartrate in a delivery system (Brimo PS DDS). There is evidence to suggest that's well as retinal neuroprotective properties Brimonidine has neuroenhancement properties to improve the function of surviving retinal cells thus improving visual function. The delivery system ensures a slow release of the drug into the target area over a period of time, as the drug is absorbed into a biodegradable material which is placed into the eye by an injection and the material dissolves and is absorbed by the body.We are estimating to recruit approximately 99 patients, who have had corrective eye surgery for macula off RRD. Patients will be randomly assigned in a ratio of 1:1:1 to treatment groups and followed for 12 months: - Brimo PS DDS Applicator System 200Ç?æg, Brimo PS DDS Applicator System 400Ç?æg or sham treatment. In addition to the UK, the recruitment is planned in Italy, Israel, India, Korea, Philippines, Australia, New Zealand and the USA.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  09/H0606/117

• Date of REC Opinion

  29 Jan 2010

• REC opinion

  Further Information Favourable Opinion