Inherited Retinal Degenerative Clinical Trial Network
Abstract
The Foundation Fighting Blindness Clinical Research Institute (FFBCRI) {formerly National Neurovision Research Institute (NNRI)], the clinical arm of the Foundation Fighting Blindness (FFB), proposes to establish the National Eye Evaluation Research (NEER) Network to be composed of a collaborative group of five Clinical Treatment and Evaluation Centers (CTECs). The intent of this new network is to advance the science of therapeutic and preventive interventions for inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD) through the conduct of clinical trials and other clinically relevant research. The scope of research to be carried out encompasses: (i) Phase I and Phase II clinical trials to evaluate the safety and efficacy of new therapeutic and preventive approaches, including devices, biopharmaceuticals, small molecules, nutritional supplements, and gene transfer approaches; (ii) natural history studies to develop standardized criteria to define disease stage, severity and progression; (iii) observational studies to enhance understanding of the natural history of these diseases for different genotypes and phenotypes; and (iv) evaluations of the reliability and validity of different available treatment outcomes measures to determine those that are most appropriate for various genotypes and phenotypes as well as for specific interventions. The NEER Network will also develop standard protocols for data collection, maintain and expand patient databases, classified by genotype and phenotype, to allow for the timely identification of eligible patients and facilities patient access for clinical trial participation, and design and conduct, in collaboration with the Department of Defense, training programs for military ophthalmologists in the latest technologies and diagnostic training regimens.
Document Details
- Document Type
- Technical Report
- Publication Date
- Oct 01, 2012
- Accession Number
- ADA602773
Entities
People
- Patricia Zilliox