Foundation Fighting Blindness Clinical Research Institute
NATIONAL EYE EVALUATION RESEARCH NETWORK
CLINICAL TREATMENT AND EVALUATION CENTERS
FOR THE STUDY OF INHERITED ORPHAN RETINAL DEGENERATIVE DISEASES
AND DRY AGE-RELATED MACULAR DEGENERATION
The FFB Clinical Research Institute has established 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
All CTECs possess:
1. Experience in Patient Diagnosis, Treatment and Management: 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.
2. 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.
3. Proven Ability to Recruit and Retain Study Participants: 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 ongoing clinical trials.
4. Experience in Clinical Trial Conduct and Oversight: 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, 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.
5. Clinical and Technical Personnel: 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.
6. Clinical Facilities, Equipment and Other Resources: The 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.
All CTECs will 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.