Clinical studies

The know-how

The Clinical Investigation Centre offers to industrial and institutional sponsors different types of support during the various stages of the clinical research studies, from the preparation phase through to the end of the study:

• Protocol writing assistance
• Methodogical advices through the Clinical Research Unit of the East of Paris, (Unité de Recherche Clinique de l'Est Parisien)
• Technical assistance for the regulatory procedures: Ethical Research Comittee and Competent Authority (AFSSAPS, The French Agency for the safety of health products),
• Help recruiting healthy volunteers or affected patients,
• Technical and logistical support to carry out the protocols,
• Involvement of a qualified medical team,
• Help entering data and analysing results.

Quality control

The role of quality assurance is to « guarantee the security of the patients participating in the biomedical research, to ensure the credibility of the research results and their recognition by the medical and scientific community ». A committee is appointed to closely supervise the preparation, implementation and revision of about twenty standard procedures. These procedures must take into account all legal, regulatory and ethical issues in the conduct of clinical investigation that are in use or currently evolving. All of this provides a scientific guarantee that the clinical trial meets international quality standards. The Clinical Investigation Centre of the Quinze-Vingts Hospital is part of the EVI.CT.SE (European Vision Institute. Clinical Trials. Sites of Excellence), a Network of European Ophthalmologic Clinical Research Sites, dedicated to perform clinical research in ophthalmology with the highest standards of quality.

On-going studies

The Clinical Investigation Centre manages several clinical studies in the field of sensory diseases. These include:

• AMD (Age-related Macular Degeneration): prevention, phenotype, genotype, neo-vessel treatment, poly-handicap, sensorial replacement

• Diabetic retinopathies: diagnosis, detection, physiopathology, treatment

• Retinal vascular occlusions: common forms, treatment

• Pigmentary retinopathies and retinal degeneration: cohorts, phenotypes, genotypes, cellular therapy

• High definition retinal imaging

• Artificial retina

• Ocular dryness and glaucoma (trials conducted by Pr Baudouin)

Read more about the on-going studies at the Clinical Investigation Centre: click here

Created on 09 March 2009. Last Updated on 19 July 2011.