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Optical coherence tomography (OCT) is a valuable noninvasive imaging tool that may be used to help evaluate the structural integrity of the retina and pharmacological or toxicological drug effects at multiple time points in preclinical toxicological studies. Although ocular histopathology is still considered the gold standard for assessment of retinal morphology, OCT provides enhanced in vivo monitoring of ocular structures and may be used to guide tissue trimming and the interpretation of histopathological changes.    Methods:   Twelve studies that involved intravitreal or subretinal test article administration in multiple laboratory animal species and employed both OCT and histopathologic assessment were identified. These data were compared to determine the degree of correlation for each identified abnormality.Results:   Severity of observed OCT and histopathological changes ranged from minimal to severe, with moderate and severe changes having a higher rate of agreement between the 2 techniques. Changes to well-defined structures, including the retinal blood vessels, optic nerve, and retinal pigment epithelium, also showed a strong correlation.Conclusions:   There was a strong correlation between OCT and histopathology in both intravitreal and subretinal injection studies, demonstrating the value of collaboration between the study ophthalmologist and pathologist and offering translatable means to monitor pharmacological or toxicological effects in preclinical toxicological studies.

Correlations Between Retinal Optical Coherence Tomography and Histopathology in Preclinical Safety Assessment of Ocular Therapies