National Neurovision Research Institute

NATIONAL NEUROVISION RESEARCH INSTITUTE

NATIONAL EYE EVALUATION RESEARCH NETWORK

ANNOUNCEMENT OF FUNDING OPPORTUNITY

REQUEST FOR PROPOSALS TO EXPAND CLINICAL TREATMENT AND EVALUATION CENTERS
FOR THE STUDY OF INHERITED ORPHAN RETINAL DEGENERATIVE DISEASES
AND DRY AGE-RELATED MACULAR DEGENERATION

The National Neurovision Research Institute (NNRI) of the Foundation Fighting Blindness (FFB) has issued a Request for Proposals (RFP) to expand the Clinical Treatment and Evaluation Centers (CTECs) of the National Eye Evaluation Research (NEER) Network to conduct clinical trials and other clinical studies in persons with inherited orphan retinal degenerative diseases and dry age-related macular degeneration (AMD).

Scope of NEER Network Clinical Research:

single and multi-site Phase I and Phase II clinical trials to evaluate the safety and efficacy of new therapeutic and preventive strategies, including, but not limited to, the use of devices, biopharmaceuticals, small molecules, nutritional supplements, and gene transfer approaches;
natural history studies to develop standardized criteria to define disease stage, severity and progression;
observational studies to enhance understanding of the natural history of inherited orphan retinal degenerations for different genotypes and phenotypes;
evaluation of the reliability and validity of the different treatment outcomes measures available to determine those that are most appropriate for various genotypes and phenotypes as well as for specific interventions;
development of standard protocols for data collection for use across multiple clinical studies and clinical trials of retinal degenerative diseases; and
establishment of new or expansion of existing patient databases, classified by genotype and phenotype, to allow for the timely identification of eligible patients and to facilitate patient access for participation in clinical trials for specific genotypes and phenotypes

Eligible Institutions/Organizations: Proposals for CTECs may be submitted by individual academic research institutions, private practices specializing in retinal diseases, or a consortium of such institutions/organizations.

Deadline for Receipt of Proposals: April 24, 2008

Minimum Requirements for CTECs: Applicants must possess and document the capability to meet the following minimum requirements in order to be considered for review and funding as one of the NEER Network CTECs:

Experience in Patient Diagnosis, Treatment and Management: A minimum of five years of experience in the diagnosis, treatment and management of patients with inherited orphan retinal degenerative diseases and dry AMD, with particular emphasis on inherited orphan retinal degenerative diseases, including but not limited to: Retinitis Pigmentosa (RP), Stargardt Disease, and Usher Syndrome.
Access to Appropriate Study Populations: Access to sufficient numbers of patients with inherited orphan retinal degenerative diseases and dry AMD, with particular emphasis on inherited orphan retinal degenerative diseases, to serve as study participants for NEER Network clinical trials and other clinical studies. This includes documentation of the suitability of the existing pool of patients and information maintained on those patients, as evidenced by databases and/or registries of patients with dry AMD, RP, Stargardt Disease, Usher Syndrome, and other inherited orphan retinal degenerative diseases, to demonstrate the availability of a sufficient number of patients for enrollment in a minimum of two Phase I and one Phase II clinical trials, as well as one natural history study over a period of three years.
Recruitment and Retention of Study Participants: Documentation of a successful track record in the recruitment and retention of study participants for clinical trials of inherited orphan retinal degenerative diseases and dry AMD, with particular emphasis on inherited orphan retinal degenerative diseases, as evidenced by enrollment in clinical trials completed over the past five years and enrollment in clinical trials ongoing at the time of proposal submission.
Clinical Trial Conduct and Oversight: Experience and expertise in the conduct and oversight of clinical trials of dry AMD and inherited orphan retinal degenerative diseases, including but not limited to, RP, Stargardt Disease, and Usher Syndrome, as evidenced by the extent of participation in clinical trials for these diseases completed over the past five years and clinical trials ongoing at the time of proposal submission, with particular emphasis on clinical trials of inherited orphan retinal degenerative diseases. In addition, documentation of experience in and established policies and procedures for monitoring and ensuring compliance with Federal regulatory requirements and Good Clinical Practice (GCP) guidelines for research involving human subjects.
Clinical and Technical Personnel: The ability to provide appropriately trained and qualified clinical and technical personnel for the conduct and oversight of clinical trials, including clinical investigators and other clinical and laboratory staff.
Clinical Facilities, Equipment and Other Resources: The ability to provide the necessary clinical facilities, equipment and other resources for patient screening, enrollment, administration of investigational products/devices, and monitoring. This includes: (i) on-site outpatient facilities; (ii) operating room facilities and services on site or through arrangements with local off-site facilities; (iii) facilities for the conduct of inpatient protocols through arrangements, including hospital admission privileges, with qualified local institutions; (iv) laboratory and diagnostic facilities and equipment, on site or through arrangements with local off-site facilities, to perform protocol-required tests to determine patient eligibility, monitor safety, and process and store specimens and other protocol-specific diagnostic materials; and (v) ophthalmic equipment both on site and at local off-site facilities.

In addition, all CTECs will be required to participate in multi-site clinical trials approved for implementation within the NEER Network in order to ensure the timely enrollment of adequate numbers of study participants and the timely completion of clinical trials.

The NNRI reserves the right to make awards on the basis of multiple factors, including: (i) the clinical capabilities, experience, expertise and resources of the applicant organizations; (ii) the need to ensure the availability of an adequate pool of patients and qualified CTECs to conduct clinical research across multiple diseases and to enroll and complete clinical trials in a timely fashion; and (ii) the need to ensure geographic distribution of CTECs and access to clinical trials for patients from across the United States.