This contract is designed to attain extramural support for developing, designing, interpreting, and evaluating clinical trials, epidemiologic and natural history studies. In addition, it will provide for outcomes research involving eye diseases and visual disorders and some preclinical studies. The focus shall be on the design of studies and the collection, analysis, and interpretation of data emanating from these studies, as well as support, and monitoring patient safety and follow-up. Contractor shall also provide analytical and data management support, as described in the work statement, for specified clinical research data bases, cost-effectiveness and economic analyses, quality of life assessment and outcomes research. This will include, but not be limited to, the following areas: analysis of Medicare and other health care databases; evaluation of existing NEI databases such as, centralized NEI Intramural Research database, the Eye Disease Case Control Study, Early Treatment Diabetic Retinopathy Study, Framingham Eye Study, and intramural AIDS and uveitis databases. The 43 active/follow-up trials in 2016 are listed below: For more info: http://clinicalstudies.info.nih.gov/cgi/protinstitute.cgi?NEI.0.html 16-EI-0169: A Pilot Study to Investigate Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis * 16-EI-0134: Studies of the Natural History, Pathogenesis and Outcome of Ocular Disorders * 16-EI-0104: Clinical and Molecular Studies in Families with Inherited Eye Disease * 16-EI-0102: PeriOcular and Intravitreal Corticosteroids for Uveitic Macular Edema (POINT) Trial * 16-EI-0090: Natural History of Spinocerebellar Ataxia Type 7 (SCA7) * 16-EI-0046: Uveitis/Intraocular Inflammatory Disease Biobank (iBank) * 16-EI-0024: Rod and Cone Mediated Function in Retinal Disease 15-EI-0202: Evaluation of Oral Minocycline in the Treatment of Geographic Atrophy Associated with Age-Related Macular Degeneration * 15-EI-0128: The Genetics of Inherited Eye Disease * 15-EI-0052: Pilot Phase I/II Study of the Evaluation of Interferon Gamma-1b Administered Topically for Macular Edema/Intraretinal Schisis Cysts in Rod-Cone Dystrophy (RCD) and Enhanced S-Cone Syndrome (ESCS) * 15-EI-0041: Patient Expectations When Enrolling in an Early-Phase Clinical Trial * 15-EI-0038: A Phase I/IIa Study of RS1 Ocular Gene Transfer for X-linked Retinoschisis * 15-EI-0020: Adaptive Optics Retinal Imaging * 14-EI-0171: The Focal Electro-Oculogram in Macular Disease * 14-EI-0064: Whole Exome and Whole Genome Sequencing for Genotyping of Inherited and Congenital Eye Conditions * 13-EI-0154: Color Vision as an Outcome Measure for Clinical Trials of Inherited Retinal Degenerations * 13-EI-0072: Microbiome and Ocular Inflammatory Disease * 13-EI-0049: Genetics of Uveal Coloboma * 12-EI-0203: Natural History of ABCA4-Related Retinopathies * 12-EI-0042: NEI Intramural Biorepository for Retinal Diseases * 11-EI-0245: Generation of Induced Pluripotent Stem (iPS) Cell Lines from Somatic Cells of Participants with Eye Diseases and from Somatic Cells of Matched Controls * 11-EI-0147: Longitudinal Investigation of Dark Adaptation in Participants with Age-Related Macular Degeneration * 10-EI-0140: Genotype-Phenotype Study of Patients with Plaquenil -Induced Retinal Toxicity, with Evaluation of the ABCA4 Gene * 10-EI-0093: Immunogenetic Mechanisms in Behcet's Disease * 08-EI-0169: Evaluation and Treatment Protocol for Potential Research Participants with Ocular Diseases * 08-EI-0102: Screening Study for the Evaluation and Diagnosis of Potential Research Participants * 08-EI-0099: Epigenetics, Molecular Genetics, and Biomarkers of Degenerative and Inflammatory Ocular Diseases * 08-EI-0043: Age-Related Eye Disease Study (AREDS) and AREDS2 Follow-Up * 08-EI-0031: Visual Motor Coordination * 06-EI-0068: The Vitreous Proteome and Inflammatory Mediators in Ocular Inflammatory Disease * 03-EI-0122: Evaluation of Immune Responses to Different Antigens in Non Infectious Ocular Inflammatory Diseases * 03-EI-0033: X-Linked Juvenile Retinoschisis - Clinical and Molecular Studies * 16-EI-0159: A Phase I/II Trial for Intravitreous Treatment of Severe Ocular von Hippel-Lindau Disease Using a Combination of the PDGF Antagonist E10030 and the VEGF Antagonist Ranibizumab * 14-EI-0173: An Investigation of Retinal Findings in Patients with Signs and Symptoms of Alzheimer's Disease Enrolled in 09-M-0198 * 14-EI-0108: Pilot Study to Evaluate Oral Minocycline in the Treatment of Cystoid Macular Edema Associated with Retinitis Pigmentosa * 14-EI-0078: A Phase 2 Multicenter Randomized Clinical Trial of Ciliary Neurotrophic Factor (CNTF) for Macular Telangiectasia Type 2 (MacTel) * 13-EI-0124: A Pilot Study of Nitisinone in the Treatment of Oculocutaneous Albinism, Type 1B * 11-EI-0264: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Central Retinal Vein Occlusions * 11-EI-0263: A Pilot Study for the Evaluation of Minocycline as a Microglia Inhibitor in the Treatment of Branch Retinal Vein Occlusions * 07-EI-0213: Laboratory of Immunology/National Eye Institute Repository * 06-EI-0236: National Ophthalmic Genotyping and Phenotyping Network, Stage 1 - Creation of DNA Repository for Inherited Ophthalmic Diseases * 06-EI-0050: Multicenter Uveitis Steroid Treatment (MUST) Trial Protocol * 05-EI-0096: Natural History and Genetic Studies of Usher Syndrome
