Clinical Research and Protocol Support Services

National Eye Institute

Investigators

Abstract

The clinical program is centrally managed by the Office of the Clinical Director http://www.nei.nih.gov/intramural/cbranch.asp which consists of a state-of-the-art outpatient facility and a multidisciplinary team of ophthalmic physicians, ophthalmic imagers, ophthalmic technicians, and clinical research coordinators, all highly skilled and trained to support clinical research. The Office of the Clinical Director continues to provide core clinical research service support to the National Eye Institute investigator during all phases of the clinical research protocol approval process from concept to approval by the NIH-IRB until completion. This support includes; diagnostic, statistical, protocol design, coordinating, regulatory, management, and clinical facilities that enable NEI clinical investigators to focus their time and resources on developing and conducting innovative and high-risk clinical research. This support covered, on average, 30 plus active protocols. A complete description of NEI's intramural scientific portfolio can be found at http://www.nei.nih.gov/intramural/. Specific NEI clinical trials being conducted at the Warren Grant Magnuson Clinical Center in Bethesda, Maryland can be found at http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html and include among others: imaging/diagnostic, diabetic macular edema, cataract, and vision motor disorders; nutritional, pharmacologic, and gene therapies for retinal vascular and genetically-inherited ocular diseases; and laser approaches and supplemental methodologies for neovascularization in age-related macular degeneration. In addition, the Office of the Clinical Director provides ophthalmic consult services to the NIH community. These consultations provide an interesting mix of rare pathologies such as neurocysticercosis (NIAID), metastatic melanoma-a disease with autoimmune ocular inflammation (NCI), graft versus host disease with ocular involvement (NHLBI), and Wegener's granulomatosis (NIAID) which has fostered long-term collaborations and has lead to clinical trials and additional investigations. Note: All human subject materials for protocols supported by the NEI clinic are recorded in the separate annual reports submitted by each PI.