Housed within Casey Eye Institute is the Translational Clinical Trial Center Reading Center, which has a collection of talented physicians and staff who have honed their skills on focused preclinical evaluation, clinical trial design and endpoint development of outcome measurements. The center has gained significant regulatory and organizational experience by being lead participants in ongoing clinical trials.
We understand there is a strong need for a center that can work with commercial and academic organizations to design clinical trials for eye diseases. Our center can offer expertise in quality control and provide analysis of data collected.
Although several reading centers exist, we are the only center that can directly assist in all aspects of clinical trial design and endpoint development, as well as offer unique services for the interpretation of Fundus Photography, OCT, visual field and electrophysiology. In addition, we work with many more visual function testing modalities, including Adaptive Optics, Microperimetry, Infrared, Fluorescein Angiography and Autofluorescence.
We offer unique web-based software for the management of clinical trials. It is remotely accessible, allowing easy upload of data and image files from clinical sites while allowing real time access for data interpretation by the TCTC Reading Center, Sponsors and Clinical Research Organizations. Due to its accessibility, we have taken great pains to ensure the data housed within our database is electronically secured. The TCTC RC software, database and server are FDA compliant for electronic records, according to 21 CFR Part 11 and we follow the FDA guidance put forth on General Principles of Software Validation; Final Guidance for Industry and FDA Staff.
The Reading Center has the following aims:
- Assist sponsors, CROs and researchers in the design of clinical trials for eye diseases. Special emphasis is given to early phase trials for gene therapy.
- Provide reading center analysis of clinical trial measures with specific emphasis on retinal visual field, imaging and electrophysiological endpoints.
- Provide the highest quality control for clinical trial outcome measures.
- Certify participant site staff and equipment in visual acuity testing, retinal imaging, visual field testing and retinal electrophysiology.