Accession Number : ADA602841


Title :   Inherited Retinal Degenerative Clinical Trial Network


Descriptive Note : Final rept. 27 Sep 2007-29 Sep 2009


Corporate Author : NATIONAL NEUROVISION RESEARCH INST OWINGS MILLS MD


Personal Author(s) : Rose, Stephen


Full Text : https://apps.dtic.mil/dtic/tr/fulltext/u2/a602841.pdf


Report Date : Oct 2009


Pagination or Media Count : 55


Abstract : The National Neurovision Research Institute (NNRI}, the clinical arm of the Foundation Fighting Blindness (FFB), has established the National Eye Evaluation Research (NEER) Network composed of a collaborative group of five Clinical Treatment and Evaluation Centers (CTECs) and a support Clinical Coordinating Center. 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; 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 standardized patient databases, classified by patient genotype and phenotype, to allow for the timely identification of eligible patients and facilitate 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 and treatment regimens.


Descriptors :   *CLINICAL TRIALS , *DEGENERATION(PHYSIOLOGY) , *RETINA , CLINICAL MEDICINE , DEGRADATION , DIAGNOSIS(MEDICINE) , DISEASES , EYE , GENES , NATURAL HISTORY , NUTRITION , OPHTHALMOLOGISTS , TEST AND EVALUATION


Subject Categories : Anatomy and Physiology
      Medicine and Medical Research


Distribution Statement : APPROVED FOR PUBLIC RELEASE