Safety and Efficacy of Brimonidine-DDS in patients with GA-AMD
Research type
Research Study
Full title
Safety and Efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration (BEACON Study)
IRAS ID
171579
Contact name
Geeta Menon
Contact email
Sponsor organisation
Allergan Limited
Eudract number
2013-003320-36
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 0 days
Research summary
Brimonidine the active substance of the investigational medication has a long history of clinical use in treatment of patients with ocular hypertension and open-angle glaucoma. Beyond its intraocular pressure (IOP)-lowering effect, brimonidine has also been reported to have neuroprotective effects. It is postulated that the neuroprotective effect of brimonidine is mediated by activation of the alpha-2 adrenoceptor which is expressed throughout the neurosensory retina and is involved in pathways that inhibit apoptosis which could prevent thining of tissue in retina caused in GA-AMD. Brimonidine Posterior segment DDS (Drug Delivery System) is a new formulation with a free base, effectively increasing the amount of active agent in the implant. The new formulation achieves rapid degradation of the implant and faster release of brimonidine.
The study investigates safety and efficacy of Brimonidine Posterior Segment Drug Delivery System in Patients with Geographic Atrophy Secondary to Age-related Macular Degeneration. The study is a randomised (treatment will be allocated by chance), double masked (neither patient nor the examining investigators in the study will know what treatment group the patient is assigned to) study where patients will either receive 400µg of Brimonidine posterior segment DDS or sham treatment (needleless procedure).
The study medication will be administered every 3 months from Baseline Visit Day 1 till Month 21 followed by 9 months of follow-up. Total duration of the study for each patient is 30 months or early exit from the study.REC name
London - Harrow Research Ethics Committee
REC reference
15/LO/0413
Date of REC Opinion
25 May 2015
REC opinion
Further Information Favourable Opinion