Brimonidine 190342-033D Retinal Detachment

• Research type

  Research Study

• Full title

  A Multicenter, Patient-Masked, Safety Extension Study to Evaluate the Biodegradation of the Brimonidine Tartrare Posterior Segment Drug Delivery System.

• IRAS ID

  64298

• Contact name

  David Charteris

• Sponsor organisation

  Allergan Ltd.

• Eudract number

  2010-019079-32

• ISRCTN Number

  n/a

• Clinicaltrials.gov Identifier

  NCT01080209

• Research summary

  This is a multicenter, phase II, patient-masked study to evaluate the safety and biodegradation of the Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimo PS DDS©). No medication will be administered to the patients throughout the course of the study and no invasive procedure will be involved. This study is being offered to all patients who have received active treatment (or sham) of Brimo PS DDS© in previous Brimo PS DDS© treatment study. Patients will remain masked to their treatment assignment in their previous Brimo PS DDS study. This means, the patients will not know whether they received study active treatment or sham (placebo). The Brimo PS DDS© Application System has been used in a wide variety of eye condition. It is biodegradable polymer based implant containing brimonidine tartrate within an applicator designed to deliver the implant directly into the back of the eye. Brimonidine Tartrate is the active ingredient that is released from the implant matrix over approximately 6 months after the treatment. The implant matrix slowly dissolves so that there is no need to remove the implant once the drug has been released. At the outset of the Brimonidine PD DDS studies it was thought that the implant would degrade of the course of 6 months, however, additional information that has recently become available show that the implant may persist for two years or longer in the eye. Based on clinical observations from studies conducted by Allergan and described in the literature, persisting implant remnants have not been associated with any safety concerns. However patients will be monitored in this study to ensure safety regarding the implant matrix during the biodegradation process. We are estimating to recruit approximately 300 patients worldwide across 40 sites across UK, Israel, Italy, Portugal, France, Germany and Czech Republic.

• REC name

  South Central - Oxford C Research Ethics Committee

• REC reference

  11/H0606/3

• Date of REC Opinion

  24 Mar 2011

• REC opinion

  Further Information Favourable Opinion