Biometrical support and information infrastructure for the Priority Research Program "Age-related Macular Degeneration; biometrics, data management, and monitoring of the clinical study "MARAN - Surgical Management of Subfoveal Choroideal Membranes in AMD by Macular Translocation"

• Applicant: Professor Dr. Ulrich Mansmann
• Subject Area: Medical Physics, Biomedical Technology
• Term: from 2002 to 2007
• Project identifier: Deutsche Forschungsgemeinschaft (DFG) - Project number 5381840

This project aims at three goals: 1. The establishing of a cross-project database which collects the data in a standardized and anonymous way. The tasks of this database are: To establish a high-quality documentation of phenotypes, genetic and imaging information, to collect information useful for the planning of future clinical studies, to support future quality assurance activities in the field of AMD, and to codify the clinical experience of the priority research program in a way to be used by future researchers for activities like meta-analyses. It is intended to stimulated synergistic effects between the projects of the priority research program, to design cross-project research problems, and to improve the exchange of information between the individual projects. 2. The installing of a high-quality methodological support within the priority research program; to improve the modelling of pathological processes; to introduce model based merging of morphological data and findings in functional, biochemical and histological processes; to initiate the analysis of pooled data with respect to problems of prognosis, genetic epidemiology, and the correspondence between imaging and functional parameters; to support the transition of results in basic research to clinical concepts (Phase I, Phase II studies). 3. To ensure that the clinical study MARAN is conducted according to the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guideline for Good Clinical Practice (GCP). This goal consists in methodological and biometrical support, data management, and monitoring.

• DFG Programme: Priority Programmes
• Subproject of: SPP 1088: Age-Related Macular Degeneration
• Participating Person: Dr. Kristina Unnebrink