190342-032D: Brimonidine Tartrate PS DDS in Patients with GA from AMD
Research type
Research Study
Full title
A Multicenter, Masked, Randomized, Sham-controlled, Paired-eye Comparison, 12 Month (Plus 12 Month Extension) Study to Evaluate the Safety and Effects on Retinal Structure and Visual Function of Brimonidine Tartrate Posterior Segment Drug Delivery System (Brimonidine Tartrate PS DDS) Applicator System in Patients with Geographic Atrophy from Age-related Macular Degeneration
IRAS ID
6823
Sponsor organisation
Allergan
Eudract number
2008-001487-37
ISRCTN Number
na
Clinicaltrials.gov Identifier
Research summary
Age-related macular degeneration (AMD) is a degenerative eye disease and the leading cause of vision loss in senior population. Vision loss from the advanced stage could be neovascular (wet), caused by the formation of new blood vessels; or atrophic (dry), likely caused by atrophy of the outermost surface of the retina, resulting in progressive retinal thinning. There are a number of avenues being developed and explored to treat GA, though none have yet shown a treatment benefit, and none have been approved. There is evidence to demonstrate that brimonidine has retinal neuroprotective properties to reduce the degeneration of the retinal pigment epithelium and photoreceptor cell death which are associated with vision loss. There is also evidence that brimonidine has neuroenhancement properties to improve the function of the surviving retinal cells, thus improving visual function.This study uses brimonidine tartrate in a delivery system (Brimo PS DDS); this ensures a slow release of the drug in the target area over a period of time. The drug is absorbed into a biodegradable material which is placed into the eye by an injection. The material dissolves and is absorbed by the body.It is estimated to recruit 100 patients in total for this study. The recruitment is planned to be held in US, Europe (United Kingdom, Portugal, Italy and Germany), Australia, S.Korea and Philippines.
REC name
London - Central Research Ethics Committee
REC reference
08/H0718/81
Date of REC Opinion
24 Feb 2009
REC opinion
Further Information Favourable Opinion