Annual Report of Activities CNC 2008 - Center for Neuroscience and ...

2. Areas of Expertise / Research / Staff2.1. Centre for Clinical TrialsThe Centre for Clinical Trials (CEC) performs randomized clinical trials with special emphasis onOphthalmology and, more specifically, in diabetic retinopathy, age‐related macular degeneration, glaucoma,cataract surgery and ocular inflammation.It is the purpose of the Centre for Clinical Trials to work with the Industry and to function as liaison between theDrug and Medical Device Industry and the Health Services.CEC has dedicated facilities and the most modern ophthalmological equipment. Its permanent staff includes twoOphthalmologists full time, one Pharmacist, five experienced Study Coordinators, five Technicians forDiagnostic Procedures, four Nurses, one Laboratory Technician and two Administrative Secretaries. EighteenOphthalmological Consultants and one Endocrinologist, collaborate regularly with the Centre.The professional organisation of the Centre for Clinical Trials with a Manual of SOP (Standardized OperatingProcedures) and its convenient location, next to the University Hospital of Coimbra and its Department ofOphthalmology are a guarantee that the deadlines are successfully met and in compliance with the ICH GoodClinical Practice Guidelines. The Centre for Clinical Trials renewed its Certificate ISO 9001:2000 to performclinical trials, thus guaranteeing the continual improvement of its work in Ophthalmological Research.CEC is also certified as an “EVI.CT.SE Site of Excellence”, that is a clinical trial in ophthalmology that complieswith ICH GCP Guidelines with written SOPs, has the necessary equipment and personnel to perform clinicaltrials and has proven expertise and scientific publications in this area.Areas of ExpertiseCharacterisation and evaluation of the most recent methods to study the initial stages of diabetic retinopathy.Evaluation of new methodologies for multimodal mapping of the macula.134Studies of the diseases of the choroid and retina and especially of their blood circulation, particularly in agerelatedmacular degeneration.Correlation between structure‐function with psychophysics tests and study the early signs of the disease.Testing new methods of early diagnosis and characterisation of macular edema and retinal vascular pathology.Evaluation of new drugs to treat glaucoma. Development of methods to correlate clinical indicators of diseaseprogression, particularly regarding optic nerve degeneration and the mechanisms of the actions of drugs beingtested.To test the pos‐operative inflammation after cataract surgery and evaluation of drugs for the prevention andtreatment of ocular inflammation after cataract surgery.ResearchOngoing Clinical TrialsClinical Trials in OphthalmologyMacular Edema after CRVOA Six‐ Month, Phase 3, Multicenter, Masked, Randomized, Sham‐Controlled Trial (with Six‐Month Open‐LabelExtension) to Assess the safety and Efficacy of 700μg and 350μg Dexamethasone Posterior Segment DrugDelivery System (DEX PS DDS) Applicator System in the Treatment of Patients with Macular Edema FollowingCentral Retinal Vein Occlusion or Branch Retinal Vein OcclusionDiabetic Macular EdemaProtocol B7A‐MC‐MBDL. Reduction in the Occurrence of center‐threatening Diabetic Macular Edema