Diabetic Macular Edema Trial OCT Endpoints

Challenge

Central subfield thickness measured by OCT anchored this diabetic macular edema trial's primary endpoint, yet automated segmentation—the software process that identifies retinal layer boundaries—fails often enough, and differently enough across devices, to compromise measurement reliability. With 70 sites using multiple OCT platforms, uncorrected segmentation errors threatened the comparability of thickness measurements on which the efficacy analysis depended.

Our Solution

Intrinsic Imaging's certified ophthalmic graders reviewed the automated segmentation of every OCT examination, manually correcting boundary errors wherever they were identified so that thickness measurements reflected true retinal anatomy rather than algorithmic artifact. Fluorescein angiography underwent centralized review of leakage characteristics under standardized grading criteria. This dual process delivered thickness and angiographic data of uniform quality across all device platforms and sites.

Results

• Retinal thickness measurements corrected across OCT devices
• Grader agreement above 0.92
• Primary endpoint data delivered on schedule