Imaging endpoints

The Casey Reading Center excels at refining and systematizing advances in retinal imaging to be used as clinical trial endpoints. This requires a team of dedicated scientists and collaboration with leaders in the field. We are fortunate to work in collaboration with the Center for Ophthalmic Optics and Lasers (COOL) lab, that is led by Dr. David Huang and Dr. Yali Jia, both world-recognized leaders in OCT structural and angiographic imaging. Insights gained in their lab are translated by a rigorous process of systemization to integrate into CRC workflows. All clinical trial data remains within the CRC at all times. 

Optical Coherence Tomography (OCT) 

We function as a reading center for cross-sectional and volumetric structural OCT. We specialize in the training and certification of clinical sites in acquiring these images. We provide validation and analysis of standardized OCT metrics from a variety of OCT manufacturers and evaluate images for the presence of pre-defined features. We utilize internally-validated proprietary software for the automated detection of retinal features such as intraretinal and subretinal fluid. We apply, evaluate, and can manually adjust segmentation algorithms from OCT manufacturers, commercial vendors, and those developed by the COOL lab. 

Optical Coherence Tomography Angiography (OCTA) 

OCT Angiography provides a non-invasive way of evaluating retinal and choroidal blood supply, and has incredible potential in evaluating and classifying retinal disease. The technological advances in the generation and interpretation of these images provides a challenge however, for robust and standardized interpretation of images. Toward that end, in addition to using OCT manufacturers' products, we use the internally-validated proprietary OCTA Toolkit, a standardized software environment for evaluation and processing of OCTA images derived from multiple manufacturers that has been demonstrated in peer-reviewed publications. We therefore are positioned to use the most advanced analysis software while following a systematic evaluation structure that can tailored to the needs of the sponsor. 

Fundus Autofluorescence (FAF) 

Fundus Autofluorescence has been used as an FDA-approved clinical trial endpoint for evaluating RPE atrophy progression in patients with geographic atrophy. We have developed a manual of procedures to obtain the highest quality FAF images. Using custom software, we are able to evaluate the area of atrophy and qualitatively assess the hyper-autofluorescent patterns present in these images. 

Color Fundus Photography (CFP) 

Color fundus photography has been a mainstay of documentation of fundus findings and safety for patients with retinal diseases since the beginning of the age of retinal imaging. We are able to analyze findings and safety signals within these images using manual grading and are evaluating several automated fundus evaluation software packages for use in future clinical trials.